Bristol Myers Squibb to Present Data at ASCO & EHA from More Than 130 Studies Across 25 Diseases Supporting Expansion into New Indications, Demonstrating Long-Term Survival, and Highlighting Novel Modalities and Research Platforms
Bristol Myers Squibb (NYSE: BMY) will present data from over 130 studies on approximately 25 cancer types and blood disorders at the 2024 ASCO and EHA meetings. Highlights include pivotal data on KRAZATI® (adagrasib) for KRASG12C-mutant NSCLC, and CheckMate -9DW trial results on Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for advanced hepatocellular carcinoma. Long-term data for Opdualag™, Opdivo, and Breyanzi® (lisocabtagene maraleucel) will be showcased, highlighting sustained clinical outcomes. Emerging science includes efficacy and safety data for new treatments like the triplet combination of nivolumab, relatlimab, and ipilimumab for advanced melanoma, and the first results of GPRC5D-directed CAR T cell therapy for multiple myeloma. The comprehensive data reflect Bristol Myers Squibb’s commitment to advancing immuno-oncology, targeted therapies, and novel treatment modalities.
- Presentation of data from over 130 studies across 25 diseases, showcasing a robust research portfolio.
- New pivotal data from Phase 3 KRYSTAL-12 study on KRAZATI® for KRASG12C-mutant NSCLC.
- CheckMate -9DW trial shows overall survival benefit of Opdivo® plus Yervoy® for advanced hepatocellular carcinoma.
- Three-year follow-up data from RELATIVITY-047 study showing sustained responses with Opdualag™ in metastatic melanoma.
- Five-year data from CheckMate -9LA trial demonstrating durable survival benefit with Opdivo plus Yervoy in metastatic NSCLC.
- First results of GPRC5D-directed CAR T cell therapy demonstrating promising efficacy and safety in multiple myeloma.
- Presentation of exploratory analysis supporting perioperative Opdivo-based regimen in resectable NSCLC.
- Disclosure of new Phase 1/2 data without FDA approval might raise questions about immediate clinical applicability.
- Safety and efficacy data for emerging treatments like RYZ101 and GPRC5D-directed CAR T cell therapy are still preliminary.
- Ongoing reliance on combinations of existing drugs may highlight lack of entirely new treatments.
- Data from multiple early-phase studies may not yet translate into immediate market impact.
“At this year’s ASCO and EHA meetings, we have the opportunity to share data across our robust and differentiated oncology portfolio including new data from pivotal studies, data that reinforce the longer-term impact our medicines are having for patients, and emerging science in the oncology space,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Drug Development, Bristol Myers Squibb. “We are focused on advancing critical research across immuno-oncology, targeted therapy, protein degradation, cell therapy, and radiopharmaceutical therapy, all with the goal of delivering potentially transformative treatment options that help provide long-term benefit for patients.”
Key data being presented by Bristol Myers Squibb at ASCO and EHA include:
New pivotal data
- Progression-free survival and overall response rate data from the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. (ASCO)
- First disclosure of results from the Phase 3 CheckMate -9DW trial demonstrating overall survival benefit with Opdivo® (nivolumab) plus Yervoy® (ipilimumab) vs. investigator’s choice of lenvatinib or sorafenib as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC). (ASCO)
Data strengthening the profile of our existing portfolio
- Three-year follow-up data from the Phase 3 RELATIVITY-047 study demonstrating sustained responses with Opdualag™ (nivolumab and relatlimab-rmbw) in previously untreated metastatic or unresectable melanoma. (ASCO)
- Five-year data from the Phase 3 CheckMate -9LA trial showing favorable clinical outcomes and durable survival benefit in patients with metastatic NSCLC treated with Opdivo plus Yervoy with chemotherapy vs. chemotherapy. (ASCO)
- Four-year follow-up data from the Phase 3 CheckMate -816 trial reinforcing neoadjuvant Opdivo plus chemotherapy as a treatment in resectable NSCLC. (ASCO)
- Exploratory analysis from the Phase 3 CheckMate -77T trial supporting the potential use of a perioperative Opdivo-based regimen as a treatment option for patients with resectable NSCLC, regardless of nodal status. (ASCO)
- Multiple subgroup analyses from the Phase 1/2 TRANSCEND CLL 004, Phase 1 TRANSCEND NHL 001 (MCL cohort) and Phase 2 TRANSCEND FL studies reinforcing the deep and durable responses with Breyanzi® (lisocabtagene maraleucel), demonstrating consistent clinical outcomes in relapsed/refractory chronic lymphocytic leukemia (CLL), relapsed/refractory mantle cell lymphoma (MCL) and relapsed/refractory follicular lymphoma (FL) across a broad study population. (ASCO/EHA)
Emerging science
- Efficacy and safety data from the Phase 2/3 RELATIVITY-048 trial evaluating the triplet combination of nivolumab, relatlimab, and ipilimumab in patients with advanced melanoma. (ASCO)
- Safety and efficacy data from the Phase 1b portion of the ACTION-1 trial of RYZ101 (an alpha-emitting radiopharmaceutical in development for SSTR2+ solid tumors) in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy. (ASCO)
- First results from the Phase 1 study of GPRC5D-directed CAR T cell therapy (BMS-986393/CC-95266) showcasing promising preliminary efficacy and safety outcomes with a single infusion of BMS-986393 in patients with relapsed or refractory multiple myeloma, including in patients with prior BCMA-directed therapy, who have received one to three prior regimens. (EHA)
- New Phase 1/2 data from the targeted protein degradation platform including the novel oral CELMoD agents iberdomide in newly diagnosed multiple myeloma, mezigdomide in relapsed/refractory multiple myeloma, and golcadomide in first-line LBCL and relapsed/refractory FL, reinforcing promising activity. (ASCO/EHA)
Please see below for Important Safety Information and full Prescribing Information for Opdualag, Opdivo, Opdivo + Yervoy, Augtyro™ (repotrectinib), Reblozyl® (luspatercept-aamt) and KRAZATI.
Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma® (idecabtagene vicleucel), Breyanzi and Inrebic® (fedratinib).
Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
Summary of Presentations:
Select Bristol Myers Squibb studies at the 2024 ASCO Annual Meeting include:
(all times in Central Time)
Abstract Title |
Author |
Presentation Type/# |
Session Title |
Session Date/Time (CDT) |
Acute Myeloid Leukemia (AML) |
||||
A post-hoc analysis of outcomes of patients with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received oral azacitidine (Oral-AZA) maintenance therapy in the QUAZAR AML-001 study. |
Stéphane De Botton |
Poster
Abstract #6522 |
Hematologic Malignancies— Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Bladder Cancer |
||||
SOGUG-Vexillum: Phase II non-randomized clinical trial of nivolumab/ipilimumab maintenance following first-line chemotherapy in unresectable locally advanced or metastatic urothelial cancer. |
Guillermo De Velasco |
Poster
Abstract #4576 |
Genitourinary Cancer—Kidney and Bladder |
Sunday, June 2, 2024
9:00 AM - 12:00 PM |
Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node-only metastatic urothelial carcinoma from the CheckMate 901 trial. |
Matthew D. Galsky |
Oral
Abstract #4509 |
Genitourinary Cancer—Kidney and Bladder |
Monday, June 3, 2024
8:00 AM - 11:00 AM |
Breast Cancer |
||||
Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 (trastuzumab imbotolimod) +/- pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (T-DXd). |
Mark Pegram |
Poster
Abstract #TPS1121 |
Breast Cancer—Metastatic |
Sunday, June 2, 2024
9:00 AM - 12:00 PM |
Chronic Lymphocytic Leukemia (CLL) |
||||
Evaluating CR as a surrogate endpoint for PFS in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): A meta-analysis of randomized controlled trials (RCT). |
Lin Wang |
Poster
Abstract #7046 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Association between treatment (tx) response and PFS and OS in R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): A 12-month landmark (LM) meta-analysis. |
Xin Wang |
Poster
Abstract #7047 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Colorectal Cancer (CRC) |
||||
A phase 2 study evaluating response and biomarkers in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC) treated with nivolumab/relatlimab. |
Eric Christenson |
Poster
Abstract #3554 |
Gastrointestinal Cancer—Colorectal and Anal |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Expanded efficacy analysis from CheckMate 8HW. |
Heinz-Joseph Lenz |
Oral
Abstract #3503 |
Gastrointestinal Cancer—Colorectal and Anal |
Sunday, June 2, 2024
8:00 AM - 11:00 AM |
Esophageal Cancer (EC) and Gastrointestinal Cancers |
||||
Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): 45-month (mo) follow-up from CheckMate 648. |
Ian Chau |
Poster
Abstract #4034 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. |
Elena Elimova |
Poster
Abstract #4040 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
Updated quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of nivolumab plus chemotherapy versus chemotherapy alone as first-line (1L) treatment for advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma (GC/GEJC/EAC): 4-year (yr) follow-up from CheckMate 649 (CM 649). |
Daniel Lin |
Poster
Abstract #4044 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
A phase II/III study of peri-operative nivolumab (nivo) and ipilimumab (ipi) in patients (pts) with locoregional esophageal (E) and gastroesophageal junction (GEJ) adenocarcinoma: Results of the neoadjuvant pathologic complete response (pCR) rate (ECOG-ACRIN EA2174). |
Jennifer Rachel Eads |
Oral
Abstract #4000 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Tuesday, June 4, 2024
9:45 AM - 12:45 PM |
Hepatocellular Carcinoma (HCC) |
||||
Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW. |
Peter Robert Galle |
Oral
Abstract #LBA4008 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Tuesday, June 4, 2024
9:45 AM - 12:45 PM |
Melanoma |
||||
Efficacy and safety of triplet nivolumab, relatlimab, and ipilimumab (NIVO + RELA + IPI) in advanced melanoma: Results from RELATIVITY-048. |
Paolo Antonio Ascierto |
Oral
Abstract #9504 |
Melanoma/Skin Cancers |
Friday, May 31, 2024
2:45 PM - 5:45 PM |
Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma (RELATIVITY-047): Overall survival (OS) and melanoma-specific survival (MSS) outcomes at 3 years. |
Hussein A. Tawbi |
Poster
Abstract #9524 |
Melanoma/Skin Cancers |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
Efficacy and safety of first-line (1L) nivolumab plus relatlimab (NIVO + RELA) versus NIVO plus ipilimumab (NIVO + IPI) in advanced melanoma: An updated indirect treatment comparison (ITC). |
Dirk Schadendorf |
Poster
Abstract #9557 |
Melanoma/Skin Cancers |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
First-line treatment preferences for advanced melanoma among oncologists and patients in the US: A discrete choice experiment. |
Michael A. Postow |
Poster
Abstract #9539 |
Melanoma/Skin Cancers |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
A phase 2, open-label, 2-cohort study to evaluate patient preference for nivolumab (NIVO) + relatlimab (RELA) fixed-dose combination (FDC) subcutaneous (SC) vs NIVO + RELA FDC intravenous (IV) and NIVO SC vs NIVO IV in participants with melanoma. |
Steven Y. Liu |
Poster
Abstract #TPS9619 |
Melanoma/Skin Cancers |
Saturday, June 1, 2024
1:30 PM - 4:30 PM |
Multiple Myeloma (MM) |
||||
Association of patient (pt) factors and pharmacodynamic biomarkers with progression-free survival (PFS) after idecabtagene vicleucel (ide-cel) in pts from KarMMa-3. |
Bertrand Arnulf |
Poster
Abstract #7527 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Impact of renal impairment (RI) on pharmacokinetics (PK) and clinical outcomes with mezigdomide plus dexamethasone (DEX) in relapsed/refractory multiple myeloma (RRMM). |
Suzanne Trudel |
Poster
Abstract #7539 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Validation of prototype biomarkers to identify risk factors of inflammatory adverse events (iAEs) following idecabtagene vicleucel (ide-cel) infusion in patients with relapsed and refractory multiple myeloma (RRMM) in KarMMa-3. |
Clara Amorosi |
Poster
Abstract #7529 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Myelodysplastic Syndromes (MDS) |
||||
Preliminary safety and efficacy of oral azacitidine (Oral-AZA) in patients (pts) with low-/Intermediate (Int)-risk myelodysplastic syndromes (MDS): Phase 2 results from the ASTREON trial. |
Guillermo Garcia-Manero |
Rapid Oral
Abstract #6509 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Saturday, June 1, 2024
8:00 AM - 9:30 AM |
Clinical benefit of luspatercept treatment (tx) in transfusion-dependent (TD), erythropoiesis-stimulating agent (ESA)-naive patients (pts) with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) in the COMMANDS trial. |
Amer Methqal Zeidan |
Poster
Abstract #6565 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Non-Hodgkin Lymphoma (includes DLBCL, LBCL, FL, MCL, etc.) |
||||
Lisocabtagene maraleucel (liso-cel) in patients (pt) with R/R mantle cell lymphoma (MCL): Subgroup analyses by number of prior systemic lines of therapy (LOT) and by response to prior Bruton tyrosine kinase inhibitor (BTKi) from the TRANSCEND NHL 001 MCL cohort (TRANSCEND-MCL). |
M. Lia Palomba |
Rapid Oral
Abstract #7016 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Sunday, June 2, 2024
4:30 PM - 6:00 PM |
Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (pt) with R/R large B-cell lymphoma (LBCL): 3-year follow-up (FU) from the randomized, phase 3 TRANSFORM study. |
Manali Kirtikumar Kamdar |
Rapid Oral
Abstract #7013 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Sunday, June 2, 2024
4:30 PM - 6:00 PM |
Real-world outcomes of lisocabtagene maraleucel (liso-cel) in patients (pt) with Richter transformation (RT) from the Center for International Blood and Marrow Transplant Research (CIBMTR). |
Allison Marie Winter |
Rapid Oral
Abstract #7010 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Sunday, June 2, 2024
4:30 PM - 6:00 PM |
Impact of clinical response and AEs on health-related quality of life (HRQoL) in patients (pts) with R/R large B-cell lymphoma (LBCL): Pooled data from 4 lisocabtagene maraleucel (liso-cel) trials. |
Patrick Connor Johnson |
Poster
Abstract #11105 |
Quality Care/Health Services Research |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Estimating the health care costs associated with receipt of lisocabtagene maraleucel: Insights from adults with mantle cell lymphoma (TRANSCEND NHL 001). |
Tycel Jovelle Phillips |
Poster
Abstract #7028 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Impact of bridging therapy (BT) on lisocabtagene maraleucel (liso-cel) treatment in patients (pt) with R/R follicular lymphoma (FL). |
M. Lia Palomba |
Poster
Abstract #7068 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Patients (pts) with R/R large B-cell lymphoma (LBCL) treated with lisocabtagene maraleucel (liso-cel) nonconforming product (NCP) under the Expanded Access Protocol (EAP). |
Mecide Meric Gharibo
|
Poster
Abstract #7026 |
Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia |
Monday, June 3, 2024
9:00 AM - 12:00 PM |
Non-Small Cell Lung Cancer (NSCLC) |
||||
KRYSTAL-12: Phase 3 Study of Adagrasib versus Docetaxel in Patients with Previously Treated Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation. |
Tony Mok |
Oral
Abstract #LBA8509 |
Clinical Science Symposium—Targeting KRAS in Non-Small Cell Lung Cancer |
Saturday, June 1, 2024
1:15 PM - 2:45 PM |
Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in patients (pts) with resectable NSCLC: 4-year update from CheckMate 816. |
Jonathan Spicer |
Rapid Oral
Abstract #LBA8010 |
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
Sunday, June 2, 2024
4:30 PM - 6:00 PM |
Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study. |
Tina Cascone |
Oral
Abstract #LBA8007 |
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
Monday, June 3, 2024
8:00 AM - 11:00 AM |
Correlation of the combination of CT-derived tumor texture and vessel tortuosity on survival outcomes for immunotherapy but not for chemotherapy in metastatic non-small cell lung cancer (mNSCLC): Results from a CheckMate227 (CM227) subset. |
Pushkar Mutha |
Poster
Abstract #8610 |
Lung cancer—Non-Small Cell Metastatic |
Monday, June 3, 2024
1:30 PM - 4:30 PM |
Five-year outcomes with first-line (1L) nivolumab + ipilimumab + chemotherapy (N + I + C) vs C in patients (pts) with metastatic NSCLC (mNSCLC) in CheckMate 9LA. |
Martin Reck |
Poster
Abstract #8560 |
Lung cancer—Non-Small Cell Metastatic |
Monday, June 3, 2024
1:30 PM - 4:30 PM |
Repotrectinib in tyrosine kinase inhibitor (TKI)-naïve patients (pts) with advanced ROS1 fusion-positive (ROS1+) NSCLC in the phase 1/2 TRIDENT-1 trial: Clinical update, treatment beyond progression and subsequent therapies. |
Alexander Drilon |
Poster
Abstract #8522 |
Lung cancer—Non-Small Cell Metastatic |
Monday, June 3, 2024
1:30 PM - 4:30 PM |
Pancreatic Cancer |
||||
Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. |
Daniel Halperin |
Poster
Abstract #3091 |
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology |
Saturday, June 1, 2024
9:00 AM - 12:00 PM |
Renal Cell Carcinoma (RCC) |
||||
Health-related quality of life (HRQoL) with nivolumab (NIVO) subcutaneous (SC) or intravenous (IV) in patients (pts) with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior therapy in the phase 3 CheckMate 67T trial. |
Saby George |
Poster
Abstract #4535 |
Genitourinary Cancer—Kidney and Bladder |
Sunday, June 2, 2024
9:00 AM - 12:00 PM |
Subcutaneous (SC) nivolumab (NIVO) vs intravenous (IV) NIVO in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Safety and patient-reported outcomes (PROs) of the randomized phase 3 CheckMate 67T trial. |
Maria T. Bourlon |
Poster
Abstract #4532 |
Genitourinary Cancer—Kidney and Bladder |
Sunday, June 2, 2024
9:00 AM - 12:00 PM |
Intratumoral T-cell infiltration and response to nivolumab plus ipilimumab in patients with metastatic clear cell renal cell carcinoma from the CheckMate-214 trial. |
Sayed Matar |
Poster
Abstract #4536 |
Genitourinary Cancer— Kidney and Bladder |
Sunday, June 2, 2024
9:00 AM - 12:00 PM |
Partitioned overall survival: Comprehensive analysis of survival states over 4 years in CheckMate 9ER comparing first-line nivolumab plus cabozantinib versus sunitinib in advanced renal cell carcinoma (aRCC). |
Charlene Mantia |
Oral
Abstract #4507 |
Genitourinary Cancer—Kidney and Bladder |
Monday, June 3, 2024
8:00 AM - 11:00 AM |
Brain Cancer |
||||
Phase II study of enasidenib in IDH2-mutated malignant sinonasal and skull base tumors. |
Elisabetta Xue |
Poster
#TPS3183 |
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology |
Saturday, June 1, 2024
9:00 AM - 12:00 PM |
All abstracts, except late-breaking abstracts, are available on the ASCO website as of 5:00 PM EDT on Thursday, May 23. All late-breaking abstracts will be available on the ASCO website at 8:00 AM EDT on the day of the scientific session for the abstract presentation.
Select Bristol Myers Squibb studies at the 2024 EHA Congress include:
(all times in Eastern Daylight and Central European Time)
Abstract Title |
Author |
Presentation Type |
Session Date/Time (EDT/CET) |
Acute Myeloid Leukemia (AML) |
|||
A post hoc analysis of outcomes of patients with acute myeloid leukemia with myelodysplasia-related changes who received oral azacitidine maintenance therapy in the QUAZAR AML-001 study. |
Maria Teresa Voso
|
Oral Abstract #S141 |
Saturday, June 15, 2024
11:30 AM - 12:45 PM (16:30 - 17:45 CET) |
Impact of TP53 mutations in patients with acute myeloid leukemia (AML) during oral azacitidine maintenance therapy: Outcomes from the QUAZAR AML-001 trial. |
Andrew H. Wei |
Poster Abstract #P560 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Chronic Lymphocytic Leukemia (CLL) |
|||
Characteristics associated with response to lisocabtagene maraleucel (liso-cel) in patients (PTS) with R/R CLL/SLL: Exploratory analyses from TRANSCEND CLL 004. |
William G. Wierda |
Oral Abstract #S158 |
Sunday, June 16, 2024
6:30 AM - 7:45 AM (11:30 - 12:45 CET) |
Multiple Myeloma (MM) |
|||
Disease characteristics and survival outcomes in patients with relapsed and refractory multiple myeloma by extramedullary disease status: findings from the Connect® MM disease registry. |
Hans Lee |
Poster Abstract #P930 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Safety and preliminary efficacy of BMS-986393, a GPRC5D CAR T cell therapy, in patients with relapsed/refractory (RR) multiple myeloma (MM) and 1-3 prior regimens: First results from a phase 1 study. |
Omar Nadeem |
Poster Abstract #P951 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Idecabtagene vicleucel (ide-cel) in patients (pts) with clinical high-risk early relapse multiple myeloma (MM) without front-line (1L) autologous stem cell transplantation (ASCT): KarMMa-2 cohort 2b. |
Xavier Leleu |
Oral Abstract #S208 |
Saturday, June 15, 2024
11:30 PM - 12:45 PM (16:30 - 17:45 CET) |
Association of patient factors and pharmacodynamic biomarkers with progression-free survival after idecabtagene vicleucel in patients from KarMMa-3. |
Bertrand Arnulf |
Poster
|
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Iberdomide is immune stimulatory and induces deep anti-myeloma activity across doses in combination with daratumumab in patients with TNE NDMM from the CC-220-MM-001 study. |
Michael Amatangelo |
Poster Abstract #P847 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Mezigdomide (mezi), tazemetostat (taz), and dexamethasone (dex) in patients (PTS) with relapsed/refractory multiple myeloma (RRMM): Preliminary results from the CA057-003 trial. |
Luciano Costa |
Poster Abstract #P903 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Improved disease status pre-infusion leads to better outcomes with standard of care idecabtagene vicleucel (ide-cel) in patients with relapsed refractory multiple myeloma (RRMM). |
Aimaz Afrough |
Poster Abstract #P939 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Myelodysplastic Syndromes (MDS) |
|||
Real-world dose escalation and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in clinical practice. |
Kashyap Patel |
Poster Abstract #P768 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Quantifying the relationship between transfusion independence and overall survival in lower-risk myelodysplastic syndromes. |
Luca Malcovati |
Poster Abstract #P782 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Value of early luspatercept use in lower-risk myelodysplastic syndromes (LR-MDS). |
David Valcárcel |
Poster Abstract #P789 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Relationship between haemoglobin and quality of life in transfusion-dependent patients with lower-risk myelodysplastic syndrome receiving luspatercept or epoetin alfa. |
Esther Oliva |
Poster Abstract #P774 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Luspatercept improves hematopoiesis in lower-risk myelodysplastic syndromes (MDS): Comparative biomarker analysis of ring sideroblast-positive and -negative subgroups from the phase 3 COMMANDS study. |
Sheida Hayati |
Poster Abstract #P763 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Clinical benefit of luspatercept in transfusion-dependent, erythropoiesis-stimulating agent-naive patients with very low-, low- or intermediate-risk myelodysplastic syndromes in the COMMANDS trial. |
Valeria Santini |
Poster Abstract #P785 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Multilineage and safety results from the COMMANDS trial in transfusion-dependent, erythropoiesis-stimulating agent-naive patients with very low-, low- or intermediate-risk myelodysplastic syndromes. |
Guillermo Garcia-Manero |
Poster Abstract #P780 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Comparative analysis of clinical benefit by genomic landscape and mutational burden of luspatercept versus epoetin alfa in lower-risk myelodysplastic syndromes (MDS) in the Phase 3 COMMANDS study. |
Rami S Komrokji |
Poster Abstract #P749 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Myelofibrosis |
|||
Patient characteristics, treatment patterns, and health outcomes in a real-world population of patients with myelofibrosis treated with fedratinib. |
Francesco Passamonti |
Poster Abstract #P1034 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Fedratinib inhibits immune evasion and restores B cell maturation: Biomarker analysis from the FREEDOM2 study. |
Claire Harrison |
Poster Abstract #P1020 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Non-Hodgkin Lymphoma (includes DLBCL, LBCL, FL, MCL, etc.) |
|||
Safety and efficacy of golcadomide, a potential first-in-class CELMOD agent ± rituximab in a phase 1/2 open-label study of patients with relapsed/refractory (r/r) follicular lymphoma (FL). |
Julio Chavez |
Poster Abstract #P1132 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Golcadomide (Golca [CC-99282]), a novel CELMoD agent, plus R-CHOP in patients (pts) with untreated aggressive B-cell lymphoma (A-BCL): Updated safety and 12-month efficacy results. |
Marc Hoffmann |
Oral Abstract #S235 |
Friday, June 14, 2024
9:45 AM - 11:00 AM (14:45 - 16:00 CET) |
Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by ASCT as second-line treatment in patients with R/R large b-cell lymphoma: 3-year follow up of TRANSFORM. |
Jeremy Abramson |
Oral Abstract #S272 |
Sunday, June 16, 2024
6:30 AM - 7:45 AM (11:30 - 12:45 CET) |
Subgroup analyses in patients with R/R MCL treated with lisocabtagene maraleucel by prior lines of therapy and response to bruton tyrosine kinase inhibitor from the TRANSCEND NHL 001 MCL cohort. |
Manali Kamdar |
Poster Abstract #P1126 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Thalassemia (Alpha or Beta) |
|||
Safety data from the dose-finding cohorts: a phase 2A study of luspatercept in pediatric patients with βeta-thalassemia. |
Antonis Kattamis |
Poster Abstract #P1516 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
Characterizing patterns of transfusion burden (TB) reduction in patients (pts) with transfusion-dependent (TD) βeta-thalassemia treated with luspatercept in the BELIEVE trial. |
Kevin Kuo |
Poster Abstract #P1522 |
Friday, June 14, 2024
1:00 PM - 2:00 PM (18:00 - 19:00 CET) |
All EHA abstracts, except late-breaking abstracts, will be available at 10:00 AM EDT on May 14. All late-breaking abstracts will be available at 10:00 AM EDT on June 3.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
OPDIVO
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in
Immune-Mediated Colitis
OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in
In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in
Immune-Mediated Hepatitis and Hepatotoxicity
OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in
In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in
OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in
Immune-Mediated Endocrinopathies
OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in
In patients receiving OPDIVO monotherapy, hypophysitis occurred in
In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in
In patients receiving OPDIVO monotherapy, thyroiditis occurred in
In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in
In patients receiving OPDIVO monotherapy, hypothyroidism occurred in
In patients receiving OPDIVO monotherapy, diabetes occurred in
Immune-Mediated Nephritis with Renal Dysfunction
OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in
Immune-Mediated Dermatologic Adverse Reactions
OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.
YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in
Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <
In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <
Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
Infusion-Related Reactions
OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in
Complications of Allogeneic Hematopoietic Stem Cell Transplantation
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.
Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone
In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Lactation
There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥
Please see
Clinical Trials and Patient Populations
Checkmate 227—previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA-previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649-previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577-adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238- adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K- adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274-adjuvant treatment of urothelial carcinoma; Checkmate 275-previously treated advanced or metastatic urothelial carcinoma; Checkmate 142-MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142-MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3-esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 040-hepatocellular carcinoma, in combination with YERVOY; Checkmate 743-previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037-previously treated metastatic melanoma; Checkmate 066—previously untreated metastatic melanoma; Checkmate 067-previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017-second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057-second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816-neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 901-Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141-recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025-previously treated renal cell carcinoma; Checkmate 214-previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER-previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039-classical Hodgkin lymphoma
OPDUALAG
INDICATION
Opdualag™ (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions (IMARs) listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
IMARs which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, they can also occur after discontinuation of Opdualag. Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if Opdualag requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
Opdualag can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD- 1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in
Immune-Mediated Colitis
Opdualag can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-mediated diarrhea or colitis occurred in
Immune-Mediated Hepatitis
Opdualag can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.
Immune-mediated hepatitis occurred in
Immune-Mediated Endocrinopathies
Opdualag can cause primary or secondary adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus, which can be present with diabetic ketoacidosis. Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. In patients receiving Opdualag, adrenal insufficiency occurred in
Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Hypophysitis occurred in
Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Thyroiditis occurred in
Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. Diabetes occurred in
Immune-Mediated Nephritis with Renal Dysfunction
Opdualag can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear etiology. In patients receiving Opdualag, immune-mediated nephritis and renal dysfunction occurred in
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
Immune-Mediated Dermatologic Adverse Reactions
Opdualag can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Rash with eosinophilia and systemic symptoms has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
Immune-mediated rash occurred in
Immune-Mediated Myocarditis
Opdualag can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology. The diagnosis of immune-mediated myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. If clinically confirmed, permanently discontinue Opdualag for Grade 2-4 myocarditis.
Myocarditis occurred in
Other Immune-Mediated Adverse Reactions
The following clinically significant IMARs occurred at an incidence of <
Infusion-Related Reactions
Opdualag can cause severe infusion-related reactions. Discontinue Opdualag in patients with severe or life- threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions. In patients who received Opdualag as a 60-minute intravenous infusion, infusion- related reactions occurred in
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody. Transplant- related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies, Opdualag can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Opdualag and for at least 5 months after the last dose of Opdualag.
Lactation
There are no data on the presence of Opdualag in human milk, the effects on the breastfed child, or the effect on milk production. Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Opdualag and for at least 5 months after the last dose.
Serious Adverse Reactions
In Relativity-047, fatal adverse reactions occurred in 3 (
Common Adverse Reactions and Laboratory Abnormalities
The most common adverse reactions reported in ≥
The most common laboratory abnormalities that occurred in ≥
Please see
KRAZATI
INDICATION
KRAZATI is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
GASTROINTESTINAL ADVERSE REACTIONS
-
In the pooled safety population, serious gastrointestinal adverse reactions observed were gastrointestinal obstruction in
1.6% , including1.4% grade 3 or 4, gastrointestinal bleeding in0.5% of patients, including0.5% grade 3, and colitis in0.3% , including0.3% grade 3. In addition, nausea, diarrhea, or vomiting occurred in89% of 366 patients, including9% grade 3. Nausea, diarrhea, or vomiting led to dosage interruption or dose reduction in29% of patients and permanent discontinuation of KRAZATI in0.3% - Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity
QTC INTERVAL PROLONGATION
- KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death
-
In the pooled safety population,
6% of 366 patients with at least one post-baseline electrocardiogram (ECG) assessment had an average QTc ≥501 ms, and11% of patients had an increase from baseline of QTc >60 msec. KRAZATI causes concentration-dependent increases in the QTc interval - Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation
- Monitor ECGs and electrolytes prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are taking medications that are known to prolong the QT interval. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity
HEPATOTOXICITY
- KRAZATI can cause hepatotoxicity
-
In the pooled safety population, hepatotoxicity occurred in
37% , and7% were grade 3 or 4. A total of32% of patients who received KRAZATI had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST);5% were grade 3 and0.5% were grade 4. Increased ALT/AST leading to dose interruption or reduction occurred in11% of patients. KRAZATI was discontinued due to increased ALT/AST in0.5% of patients - Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity
INTERSTITIAL LUNG DISEASE /PNEUMONITIS
-
KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. In the pooled safety population, ILD/pneumonitis occurred in
4.1% of patients,1.4% were grade 3 or 4, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was discontinued due to ILD/pneumonitis in0.8% of patients - Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified
ADVERSE REACTIONS
-
The most common adverse reactions (≥
25% ) are nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, decreased appetite
FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
- Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential
Please see
BREYANZI
INDICATION
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
-
adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse after first line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
- relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
- Adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- Adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Important Safety Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES
|
Cytokine Release Syndrome (CRS)
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI which enrolled a total of 614 patients with non-Hodgkin lymphoma (NHL), CRS occurred in
Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.
Neurologic Toxicities
Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.
In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in
The most common neurologic toxicities (≥
CRS and Neurologic Toxicities Monitoring
Monitor patients daily for at least 7 days following BREYANZI infusion at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:
- Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
- Certified healthcare facilities must have on-site, immediate access to tocilizumab.
- Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-866-340-7332.
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).
Serious Infections
Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in
Febrile neutropenia developed after BREYANZI infusion in
Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.
Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 26 of 29 patients with prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.
Prolonged Cytopenias
Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in
Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.
Secondary Malignancies
Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (
Adverse Reactions
The most common adverse reactions (incidence ≥
- LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
- CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
- FL are cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
REBLOZYL
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Important Safety Information
WARNINGS AND PRECAUTIONS
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (
Hypertension
Hypertension was reported in
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.
ADVERSE REACTIONS
ESA-naïve adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥
The most common (≥
ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes
Grade ≥3 (≥
The most common (≥
LACTATION
It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.
DRUG ABUSE POTENTIAL
Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.
Please see
ABECMA
INDICATION
ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES
|
Warnings and Precautions:
Early Death:
In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254;
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Of the 349 patients who received ABECMA in clinical trials, 226 (
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA. In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in
At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff.
Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in
In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.
In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.
HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.
ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or contact Bristol-Myers Squibb at 1-866-340-7332.
Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.
Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion.
In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in
Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in
Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.
Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies,
Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.
Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in
Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in
Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.
Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.
Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.
Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy.
Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
INREBIC
INDICATION
INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S
Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.
WARNINGS AND PRECAUTIONS
Encephalopathy, including Wernicke’s: Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in
Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.
Anemia: New or worsening Grade 3 anemia occurred in
Thrombocytopenia: New or worsening Grade ≥3 thrombocytopenia during the randomized treatment period occurred in
Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in
Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in
Amylase and Lipase Elevation: Grade 3 or higher amylase
ADVERSE REACTIONS:
The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (
DRUG INTERACTIONS:
Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC.
PREGNANCY/LACTATION: Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.
RENAL IMPAIRMENT: Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.
HEPATIC IMPAIRMENT: Avoid use of INREBIC in patients with severe hepatic impairment.
Please see full Prescribing Information, including Boxed WARNING, and Summary of Product Characteristics for INREBIC.
AUGTYRO
Augtyro (TPX-0005, BMS-986472) is a next-generation tyrosine kinase inhibitor (TKI) targeting ROS1-positive or NTRK-positive locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), where there remain significant unmet medical needs for patients. Augtyro was designed to improve durability of response and with favorable properties for human brain penetration to enhance intracranial activity. It is being studied in a registrational Phase 1/2 trial in adults (TRIDENT-1) and a Phase 1/2 trial in pediatric patients (CARE).
Augtyro has demonstrated clinically meaningful results and was granted three Breakthrough Therapy Designations (BTDs) by the FDA for the treatment of patients with: ROS1-positive metastatic NSCLC who have not been treated with a ROS1 TKI; ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy; and advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior tropomyosin receptor kinase (TRK) TKIs (with or without prior chemotherapy) and have no satisfactory alternative treatments.
Augtyro was also previously granted four fast-track designations in patients with: ROS1-positive advanced NSCLC who have been treated with disease progression following one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI; ROS1-positive advanced NSCLC who have not been treated with a ROS1 TKI; ROS1-positive advanced NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy; and advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. Augtyro was also granted an Orphan Drug designation by the
INDICATION
AUGTYROTM (repotrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Warnings & Precautions
IMPORTANT SAFETY INFORMATION
Central Nervous System Adverse Reactions
-
Among the 351 patients who received AUGTYRO in the TRIDENT-1 study, a broad spectrum of central nervous system (CNS) adverse reactions including dizziness, ataxia, and cognitive disorders occurred in
75% with Grade 3 or 4 events occurring in4% . Dizziness, including vertigo, occurred in64% and Grade 3 dizziness occurred in2.8% of patients. The median time to onset was 6 days (1 day to 1.4 years). Dose interruption was required in9% of patients, and12% required dose reduction of AUGTYRO due to dizziness. -
Ataxia, including gait disturbance and balance disorder, occurred in
29% of the 351 patients; Grade 3 ataxia occurred in0.3% . The median time to onset was 15 days (1 day to 1.4 years). Dose interruption was required in6% of patients,8% required dose reduction and one patient (0.3% ) permanently discontinued AUGTYRO due to ataxia. -
Cognitive disorder, including memory impairment and disturbance in attention, occurred in
23% of the 351 patients. Cognitive disorders included memory impairment (13% ), disturbance in attention (11% ), and confusional state (2% ); Grade 3 cognitive disorders occurred in0.9% of patients. The median time to onset of cognitive disorders was 37 days (1 day to 1.4 years). Dose interruption was required in2% of patients,1.7% required dose reduction and0.6% permanently discontinued AUGTYRO due to cognitive adverse reactions. -
Mood disorders occurred in
6% of the 351 patients. Mood disorders occurring in >1% of patients included anxiety (2.8% ), irritability (1.1% ), and depression (1.4% ); Grade 4 mood disorders (mania) occurred in0.3% of patients. Dose interruption was required in0.3% of patients and0.3% required a dose reduction due to mood disorders. -
Sleep disorders including insomnia and hypersomnia occurred in
15% of the 351 patients. Sleep disorders observed in >1% of patients were somnolence (8% ), insomnia (6% ) and hypersomnia (1.1% ). Dose interruption was required in0.9% of patients, and0.3% required a dose reduction due to sleep disorders. - The incidences of CNS adverse reactions reported were similar in patients with and without CNS metastases.
- Advise patients not to drive or use machines if they are experiencing CNS adverse reactions. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue AUGTYRO based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis
-
Among the 351 patients treated with AUGTYRO, ILD/pneumonitis (pneumonitis [
2.6% ] and interstitial lung disease [0.3% ]) occurred in2.9% ; Grade 3 ILD/pneumonitis occurred in1.1% . The median time to onset was 45 days (19 days to 0.9 years). Dose interruption was required in1.4% of patients,0.6% required dose reduction, and1.1% permanently discontinued AUGTYRO due to ILD/pneumonitis. - Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold AUGTYRO in patients with suspected ILD/pneumonitis and permanently discontinue AUGTYRO if ILD/pneumonitis is confirmed.
Hepatotoxicity
-
Among the 351 patients treated with AUGTYRO, increased alanine transaminase (ALT) occurred in
35% , increased aspartate aminotransferase (AST) occurred in40% , including Grade 3 or 4 increased ALT in2% and increased AST in2.6% . The median time to onset of increased ALT or AST was 15 days (range: 1 day to 1.9 years). Increased ALT or AST leading to dose interruptions or reductions occurred in2.8% and1.4% of patients, respectively. Hyperbilirubinemia leading to dose interruptions occurred in0.6% . - Monitor liver function tests, including ALT, AST and bilirubin, every 2 weeks during the first month of treatment, then monthly thereafter and as clinically indicated. Withhold and then resume at same or reduced dose upon improvement or permanently discontinue AUGTYRO based on the severity.
Myalgia with Creatine Phosphokinase (CPK) Elevation
-
Among the 351 patients treated with AUGTYRO, myalgia occurred in
13% of patients, with Grade 3 in0.6% . Median time to onset of myalgia was 19 days (range: 1 day to 2 years). Concurrent increased CPK within a 7-day window was observed in3.7% of patients. AUGTYRO was interrupted in one patient with myalgia and concurrent CPK elevation. - Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor serum CPK levels during AUGTYRO treatment and monitor CPK levels every 2 weeks during the first month of treatment and as needed in patients reporting unexplained muscle pain, tenderness, or weakness. Initiate supportive care as clinically indicated. Based on severity, withhold and then resume AUGTYRO at same or reduced dose upon improvement.
Hyperuricemia
-
Among the 351 patients treated with AUGTYRO, 18 patients (
5% ) experienced hyperuricemia reported as an adverse reaction,0.9% experienced Grade 3 or 4 hyperuricemia. One patient without pre-existing gout required urate-lowering medication. - Monitor serum uric acid levels prior to initiating AUGTYRO and periodically during treatment. Initiate treatment with urate-lowering medications as clinically indicated. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue AUGTYRO based on severity.
Skeletal Fractures
-
Among 351 adult patients who received AUGTYRO, fractures occurred in
2.3% . Fractures involved the ribs (0.6% ), feet (0.6% ), spine (0.3% ), acetabulum (0.3% ), sternum (0.3% ), and ankles (0.3% ). Some fractures occurred at sites of disease and prior radiation therapy. The median time to fracture was 71 days (range: 31 days to 1.4 years). AUGTYRO was interrupted in0.3% of patients. - Promptly evaluate patients with signs or symptoms (e.g., pain, changes in mobility, deformity) of fractures. There are no data on the effects of AUGTYRO on healing of known fractures and risk of future fractures.
Embryo-Fetal Toxicity
- Based on literature reports in humans with congenital mutations leading to changes in tropomyosin receptor tyrosine kinase (TRK) signaling, findings from animal studies, and its mechanism of action, AUGTYRO can cause fetal harm when administered to a pregnant woman.
- Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with AUGTYRO and for 2 months following the last dose, since AUGTYRO can render some hormonal contraceptives ineffective.
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment with AUGTYRO and for 4 months after the last dose.
Adverse Reactions
-
Among 351 patients who received AUGTYRO for ROS1-positive NSCLC and other solid tumors in the TRIDENT-1 trial, the most common (>
20% ) adverse reactions were dizziness (64% ), dysgeusia (50% ), peripheral neuropathy (47% ), constipation (37% ), dyspnea (30% ), ataxia (29% ), fatigue (29% ), cognitive disorders (23% ), and nausea (20% ). -
In a subset of 264 patients who received AUGTYRO for ROS1-positive NSCLC, the most common (≥
20% ) adverse reactions were dizziness (63% ), dysgeusia (48% ), peripheral neuropathy (47% ), constipation (36% ), dyspnea (30% ), ataxia (28% ), fatigue (24% ), cognitive disorders (23% ), and muscular weakness (21% ).
Drug Interactions
Effects of Other Drugs on AUGTYRO
Strong and Moderate CYP3A Inhibitors
- Avoid concomitant use with strong or moderate CYP3A inhibitors. Concomitant use of AUGTYRO with a strong or a moderate CYP3A inhibitor may increase repotrectinib exposure, which may increase the incidence and severity of adverse reactions of AUGTYRO. Discontinue CYP3A inhibitors for 3 to 5 elimination half-lives of the CYP3A inhibitor prior to initiating AUGTYRO.
P-gp Inhibitors
- Avoid concomitant use with P-gp inhibitors. Concomitant use of AUGTYRO with a P-gp inhibitor may increase repotrectinib exposure, which may increase the incidence and severity of adverse reactions of AUGTYRO.
Strong and Moderate CYP3A Inducers
- Avoid concomitant use with strong or moderate CYP3A inducers. Concomitant use of AUGTYRO with a strong or moderate CYP3A inducer may decrease repotrectinib plasma concentrations, which may decrease efficacy of AUGTYRO.
Effects of AUGTYRO on other Drugs
Certain CYP3A4 Substrates
- Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates, where minimal concentration changes can cause reduced efficacy. If concomitant use is unavoidable, increase the CYP3A4 substrate dosage in accordance with approved product labeling.
- Repotrectinib is a CYP3A4 inducer. Concomitant use of repotrectinib decreases the concentration of CYP3A4 substrates, which can reduce the efficacy of these substrates.
Contraceptives
- Repotrectinib is a CYP3A4 inducer, which can decrease progestin or estrogen exposure to an extent that could reduce the effectiveness of hormonal contraceptives.
- Avoid concomitant use of AUGTYRO with hormonal contraceptives. Advise females to use an effective nonhormonal contraceptive.
Please see
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in
About Bristol Myers Squibb and 2seventy bio
Abecma is being jointly developed and commercialized in the
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the treatments and combination treatments may not receive regulatory approval for the indications described in this release will be commercially successful, and any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether the treatments and combination treatments for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
corporatefinancial-news
View source version on businesswire.com: https://www.businesswire.com/news/home/20240522033055/en/
Bristol Myers Squibb
Media Inquiries:
media@bms.com
Investors:
investor.relations@bms.com
Source: Bristol Myers Squibb
FAQ
What new data will Bristol Myers Squibb present at ASCO 2024?
What is the significance of the CheckMate -9DW trial for BMY?
What are the long-term results shown for Opdualag™?
How does BMY’s data presentation at ASCO and EHA impact their oncology portfolio?
What emerging therapies are included in BMY’s presentation?
