Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023
First disclosure from Phase 3 COMMANDS study, selected for both ASCO’s official press program and EHA’s plenary session, highlights potential of Reblozyl (luspatercept-aamt) as first-line treatment of anemia in very low- to intermediate-risk myelodysplastic syndromes
First presentation of results from primary analysis of TRANSCEND CLL 004 demonstrates benefit of Breyanzi (lisocabtagene maraleucel) in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
New TRIDENT-1 data reinforce potential of precision medicine repotrectinib in patients with locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer (NSCLC), including those with central nervous system metastases
Four-year data in NSCLC from CheckMate -9LA demonstrate durable long-term survival benefit for Opdivo (nivolumab) + Yervoy (ipilimumab) + platinum-based chemotherapy and three-year data from CheckMate -816 continue to demonstrate long-term clinical benefits of Opdivo + chemotherapy in patients with earlier stages of NSCLC
Bristol Myers Squibb to Host Virtual Investor Event on Tuesday, June 6, 2023, to Discuss ASCO Highlights
“We look forward to sharing our research during ASCO, EHA and ICML, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “The breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. Positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. Our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most.”
Key data being presented by Bristol Myers Squibb at ASCO, EHA and ICML 2023 include:
Hematology
- First disclosure of data from the Phase 3 COMMANDS study of Reblozyl (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (RBC) transfusions and are ESA-naïve. (ASCO/EHA)
- Preliminary results from the dose-escalation and expansion components of the Phase 1 CC-93269-MM-001 study demonstrate subcutaneous administration of bispecific T-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (EHA)
- Results from the dose-escalation components of a Phase 1/2 study evaluating BET inhibitor BMS-986158 as monotherapy and in combination with ruxolitinib or Inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (EHA)
- First disclosure of clinical data from a Phase 1b study evaluating golcadomide (CC-99282), a novel CELMoDTM agent, in combination with R-CHOP in patients with previously untreated aggressive B-cell lymphoma will be presented. (ICML)
- Results from a dose-expansion cohort of the Phase 1/2 CC-92480-MM-001 study, evaluating novel CELMoD agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (EHA)
Cell Therapy
- First disclosure of data from the primary analysis of the TRANSCEND CLL 004 study of Breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (ASCO)
- Multiple analyses from the KarMMa-3 study showed improved health-related quality of life (HRQOL) and patient-reported outcomes, in addition to lower risk of disease progression, with Abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (ASCO/EHA)
- Interim results from Phase 1 study of GPRC5D CAR T (BMS-986393/CC-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior BCMA-directed therapy. (EHA)
Solid Tumor
- Results from the registrational TRIDENT-1 trial showed durable clinical activity with repotrectinib in ROS1 tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1-positive NSCLC with or without baseline central nervous system metastases, including robust intracranial responses. (ASCO)
- Four-year data from the Phase 3 CheckMate -9LA trial reinforce durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic NSCLC, including subgroups with higher unmet needs. (ASCO)
- Three-year results demonstrated long-term clinical benefit of neoadjuvant Opdivo with chemotherapy in patients with resectable NSCLC who received definitive surgery in the Phase 3 CheckMate -816 trial. (ASCO)
- Biomarker analyses from the Phase 3 CheckMate -76K trial support a potential clinical benefit of Opdivo for the adjuvant treatment of patients with stage IIB/C melanoma, across all biomarker sub-groups. (ASCO)
- Three-year data from the Phase 3 CheckMate -649 trial evaluating Opdivo plus chemotherapy continue to demonstrate durable long-term survival and HRQOL benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (ASCO)
- Two-year data from the Phase 2/3 RELATIVITY-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (ASCO)
Please see below for Important Safety Information and full Prescribing Information for Reblozyl, Opdualag, Opdivo, and Opdivo+Yervoy.
Please see below for Important Safety Information and full Prescribing Information, including Boxed Warnings, for Abecma, Breyanzi and Inrebic.
Investor Event
Bristol Myers Squibb will host a virtual Investor Event on Tuesday, June 6, 2023, from 7:00-8:00 a.m. CT/8:00-9:00 a.m. ET to discuss data presented at ASCO. Company executives will provide an overview of data presented and address questions from investors and analysts.
Investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. An archived edition of the session will be available later that day.
Summary of Presentations
Select Bristol Myers Squibb studies at the 2023 ASCO Annual Meeting include:
Abstract Title |
Author |
Presentation
|
Session Title |
Session
|
Acute Myeloid Leukemia |
||||
Implications for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic: A Connect Myeloid Registry study. |
Bart L. Scott |
Poster
Abstract #7021 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
9:00 AM –
|
Gastrointestinal |
||||
First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): 64-month (mo) follow-up from CheckMate 142. |
Heinz-Josef Lenz |
Poster
Abstract #3550 |
Gastrointestinal Cancer—Colorectal and Anal |
Monday,
9:00 AM –
|
Predictive value of tumor-infiltrating lymphocyte (TIL) dynamics in the tumor microenvironment (TME) during preoperative chemoradiotherapy (CRT) on pathologic complete response (pCR) in microsatellite-stable (MSS) locally advanced rectal cancer (LARC). |
Mitsuho Imai |
Poster
Abstract #3608 |
Gastrointestinal Cancer—Colorectal and Anal
|
Monday,
9:00 AM –
|
Nivolumab (NIVO) plus chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 3-year follow-up from CheckMate 649. |
Yelena Y. Janjigian |
Poster
Abstract #4025 |
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Monday,
9:00 AM –
|
Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): 36-month results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649. |
Elena Elimova |
Poster
Abstract #4038
|
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Monday,
9:00 AM –
|
Genitourinary |
||||
Health-related quality of life (HRQoL) of risk-based patient subgroups with advanced renal cell cancer (aRCC) treated with nivolumab plus cabozantinib (NIVO+CABO) vs sunitinib (SUN) in the CheckMate 9ER trial. |
David Cella |
Poster
Abstract #4527 |
Genitourinary Cancer—Kidney and Bladder |
Saturday,
9:00 AM –
|
Adjuvant nivolumab plus ipilimumab vs placebo for patients with localized renal cell carcinoma at high risk of relapse after nephrectomy: Subgroup analyses from the phase 3 CheckMate 914 (part A) trial. |
Robert J. Motzer |
Oral
Abstract #4506 |
Genitourinary Cancer—Kidney and Bladder |
Monday,
12:30 PM –
|
Gynecologic |
||||
Preliminary antitumor activity of the combination of COM701 + BMS-986207 + nivolumab in patients with recurrent, metastatic MSS endometrial cancer. |
Drew W. Rasco |
Poster
Abstract #5595 |
Gynecologic Cancer |
Monday,
2:15 PM –
|
Efficacy and final safety analysis of pre- and co-administration of nivolumab (Nivo) with concurrent chemoradiation (CCRT) followed by Nivo maintenance therapy in patients (pts) with locally advanced cervical carcinoma (LACvCa): Results from the phase I trial, GOTIC-018. |
Kazuto Nakamura |
Poster
Abstract #5519 |
Gynecologic Cancer |
Monday,
5:30 PM –
|
Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers. |
Cassandra Vandenberg |
Publication Only
Abstract #e17634 |
Gynecologic Cancer |
N/A |
Head & Neck |
||||
A phase 2, open-label, multicenter study investigating efficacy and safety of |
Kevin Joseph Harrington |
Poster
Abstract #TPS6106 |
Head and Neck Cancer |
Monday,
2:15 PM –
|
Lymphoma |
||||
Longitudinal, prospective cardiovascular and metabolic risk in treatment-naive patients with chronic myeloid leukemia in chronic phase (CML-CP) starting tyrosine kinase inhibitor (TKI) therapy in a real-world setting. |
Javid J. Moslehi |
Poster
Abstract #7053 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
9:00 AM –
|
Subgroup analyses of primary refractory (refr) vs early relapsed (rel) large B-cell lymphoma (LBCL) from the TRANSFORM study of lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line (2L) therapy. |
Loretta J. Nastoupil |
Poster
Abstract #7526 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday,
9:00 AM –
|
Response-adapted therapy (tx) with nivolumab plus brentuximab vedotin (nivo + BV) without autologous hematopoietic cell transplantation (auto-HCT) in children, adolescents, and young adults (CAYA) with low-risk relapsed/refractory (R/R) classic Hodgkin lymphoma (cHL): CheckMate 744. |
Paul David Harker-Murray
|
Poster
Abstract #7515 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Monday,
2:15 PM –
|
Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004. |
Tanya Siddiqi |
Oral
Abstract #7501 |
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia |
Tuesday,
10:45 AM –
|
Melanoma |
||||
The validity of a machine learning algorithm in predicting response to immune checkpoint inhibitors in melanoma. |
Faisal Fa’ak |
Poster
Abstract #9523 |
Melanoma/Skin Cancers |
Saturday,
2:15 PM –
|
Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of |
Joseph J. Sacco |
Poster
Abstract #9527 |
Melanoma/Skin Cancers |
Saturday,
2:15 PM –
|
Durable clinical outcomes in patients (pts) with advanced melanoma and progression-free survival (PFS) ≥3y on nivolumab (NIVO) ± ipilimumab (IPI) or IPI in CheckMate 067. |
F. Hodi |
Poster
Abstract #9542 |
Melanoma/Skin Cancers |
Saturday,
2:15 PM –
|
Efficacy and safety of first-line (1L) nivolumab plus relatlimab (NIVO + RELA) versus NIVO plus ipilimumab (NIVO + IPI) in advanced melanoma: An indirect treatment comparison (ITC) using patient-level data (PLD). |
Dirk Schadendorf |
Poster
Abstract #9552 |
Melanoma/Skin Cancers |
Saturday,
2:15 PM –
|
Association of circulating tumor DNA kinetics with disease recurrence in patients with stage IIB/C/IV melanoma treated with adjuvant immunotherapy in CheckMate 238. |
Mahrukh M. Syeda |
Poster
Abstract #9577 |
Melanoma/Skin Cancers |
Saturday,
2:15 PM –
|
Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047. |
Hussein A. Tawbi |
Oral
Abstract #9502 |
Melanoma/Skin Cancers |
Monday,
4:00 PM –
|
Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209 -76K). |
Georgina V. Long |
Oral
Abstract #9504 |
Melanoma/Skin Cancers |
Monday,
4:00 PM –
|
Merkel Cell Carcinoma |
||||
Non-comparative, open-label, international, multicenter phase I/II study of nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with recurrent/metastatic Merkel cell carcinoma (MCC) (CheckMate 358). |
Shailender Bhatia |
Oral
Abstract #9506 |
Melanoma/Skin Cancers |
Monday,
4:00 PM –
|
Multiple Myeloma |
||||
Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class–exposed (TCE) relapsed and refractory multiple myeloma (RRMM). |
Julia Piasecki |
Poster
Abstract #8031 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday,
9:00 AM –
|
Health related quality of life (HRQoL) in patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE RRMM) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: Patient-reported outcomes (PROs) from KarMMa-3 phase 3 randomized controlled trial (RCT). |
Michel Delforge |
Poster
Abstract #8032 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday,
9:00 AM –
|
Tumor-intrinsic features associated with progression-free survival (PFS) in patients (pts) with relapsed and refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel). |
Nicholas Strong |
Poster
Abstract #8035 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday,
9:00 AM –
|
EXCALIBER-RRMM: A phase 3, two-stage study of iberdomide, daratumumab, and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM). |
Sagar Lonial |
Poster
Abstract #TPS8069 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday,
9:00 AM –
|
A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM): SUCCESSOR-2. |
Paul G. Richardson
|
Poster
Abstract #TPS8070 |
Hematologic Malignancies—Plasma Cell Dyscrasia |
Monday,
9:00 AM –
|
Myelodysplastic Syndrome |
||||
Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)-‑naive transfusion-dependent (TD) patients (pts) with lower-‑risk myelodysplastic syndromes (LR-MDS). |
Guillermo Garcia-Manero |
Oral
Abstract #7003 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Friday,
2:00 PM –
|
Hematologic and transfusion outcomes in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) receiving luspatercept: Real-world assessment in the community practice setting. |
Sudipto Mukherjee |
Poster
Abstract #7057 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
9:00 AM –
|
Clinical outcomes by SF3B1 mutation status in patients (pts) with lower-risk myelodysplastic syndrome (LR-MDS) retreated with erythropoiesis-stimulating agents (ESAs). |
Adeola Y. Makinde |
Poster
Abstract #7071 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
9:00 AM –
|
A phase 2/3 trial of oral azacitidine (Oral-AZA) in patients (pts) with low- or intermediate-risk myelodysplastic syndromes (MDS). |
Guillermo Garcia-Manero
|
Poster
Abstract #TPS7083 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
9:00 AM –
|
Myelofibrosis |
||||
Safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis: Results from the ACE-536-MF-001 study. |
Aaron Thomas Gerds |
Poster
Abstract #7016 |
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant |
Monday,
12:30 PM –
|
Thoracic |
||||
Phase 2 small cell lung cancer (SCLC) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab. |
Koichi Azuma |
Poster
Abstract #8593 |
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
Sunday,
9:00 AM –
|
Clinical outcomes with neoadjuvant nivolumab (N) + chemotherapy (C) vs C by definitive surgery in patients (pts) with resectable NSCLC: 3-y results from the phase 3 CheckMate 816 trial. |
Jonathan Spicer |
Poster
Abstract #8521 |
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
Sunday,
12:30 PM –
|
Intracranial and systemic efficacy of repotrectinib in advanced ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) and central nervous system metastases (CNS mets) in the phase 1/2 TRIDENT-1. |
Jessica Jiyeong Lin |
Poster
Abstract #9017 |
Lung Cancer—Non-Small Cell Metastatic |
Sunday,
5:30 PM –
|
First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4‑y clinical update and outcomes by tumor histologic subtype (THS). |
David Paul Carbone |
Poster
Abstract #LBA9023 |
Lung Cancer—Non-Small Cell Metastatic |
Sunday,
5:30 PM –
|
All abstracts except late-breaking abstracts will be available on the ASCO website at 5:00 PM EDT on Thursday, May 25. 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 2023 EHA Congress include:
Abstract Title |
Author |
Presentation
|
Session
|
Acute Myeloid Leukemia |
|||
Longitudinal characterization of molecular variants at remission and relapse: subanalyisis of the QUAZAR AML-001 trial. |
Andrew Wei |
Poster
Abstract #P411 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Disease monitoring of NPM1-mutant (mut) acute myeloid leukemia (AML) using measurable residual disease (MRD) assessments during oral azacitidine (oral-AZA) treatment (tx): a QUAZAR AML-001 subanalysis. |
Gail Roboz |
Poster
Abstract #P459 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
A real-world evaluation of treatment patterns and outcomes of acute myeloid leukemia induction therapies in the community setting. |
Keri Maher |
Poster
Abstract #P515 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Phase 1b OMNIVERSE trial: Safety and tolerability of oral azacitidine in combination with venetoclax for treatment of acute myeloid leukemia. |
Shaun Fleming |
Poster
Abstract #P567 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Real-world characteristics and use of antiemetic therapies among patients with acute myeloid leukemia treated with oral azacitidine maintenance therapy. |
Ying Qui
|
Poster
Abstract #P587 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Implications of registry data for acute myeloid leukemia (AML) treatment and care during the COVID-19 pandemic. |
John Kelly |
Poster
Abstract #P589 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Beta Thalassemia |
|||
Effect of luspatercept on bone mineral density in patients with beta-thalassemia enrolled in the phase 3 BELIEVE trial. |
Thomas D. Coates |
Poster
Abstract #P1466
|
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Long-term erythroid response data from patients (pts) with non-transfusion-dependent beta-thalassemia (NTDT) receiving luspatercept in the BEYOND trial. |
Ali T. Taher |
Oral
Abstract #S273 |
Sunday, June 11, 2023
5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST) |
Alpha Thalassemia |
|||
Trial in Progress: A phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of luspatercept to treat anemia in adults with alpha-thalassemia. |
Vip Viprakasit |
Abstract only publication
Abstract #PB2535 |
N/A |
Lymphoma |
|||
Economic burden in chronic lymphocytic leukemia (CLL) for patients with ≥2 prior lines of therapy including a bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i). |
Farrukh Awan |
Poster
Abstract #P1696 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Qualitative interviews to describe burden in patients (pt) with third-line or later CLL/SLL with prior exposure to bruton tyrosine kinase inhibitor (BTKi) and/or B-cell lymphoma 2 inhibitor (BCL2i). |
Mona L Martin |
Abstract only publication
Abstract #PB2696 |
N/A |
Multiple Myeloma |
|||
Synergistic antitumor activity of the BCMA 2+1 T cell engager (TCE) alnuctamab (ALNUC; BMS-986349; CC-93269) and CELMoD agents in multiple myeloma (MM) preclinical models. |
Bruno Paiva |
Poster
Abstract #P799 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the KarMMa-3 study of triple-class-exposed relapsed and refractory multiple myeloma. |
Marc S. Raab |
Poster
Abstract #P801 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; BB2121) who are at risk for severe/refractory inflammatory adverse events. |
Yi Lin |
Poster
Abstract #P809 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Soluble factors correlated with cytokine release syndrome (CRS) with IV vs subcutaneous (SC) alnuctamab (ALNUC; BMS-986349; CC-93269) in patients with relapsed/refractory multiple myeloma (RRMM). |
Luciano Costa |
Poster
Abstract #P825 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
| Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): KarMMa-3 subgroup analysis by prior lines of therapy. | Saloman Manier |
Poster
Abstract #P866 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Mezigdomide (MEZI) plus dexamethasone (DEX) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): results from the dose-expansion phase of the CC-92480-MM-001 trial. |
Nizar J. Bahlis |
Poster
Abstract #P868 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (ASCT): results from KarMMa-2 cohort 2c. |
Melissa Alsina |
Poster
Abstract #P871 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Pomalidomide, daratumumab, and dexamethasone after lenalidomide treatment in patients with relapsed or refractory multiple myeloma (RRMM): final overall survival analysis of the phase 2 MM-014 study. |
Nizar J. Bahlis |
Poster
Abstract #P882 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Alnuctamab (ALNUC; BMS-986349; CC-93269), a BCMA × CD3 T-cell engager, in patients (pts) with relapsed/refractory multiple myeloma (RRMM): latest results from a phase 1 first-in-human clinical study. |
Sandy W. Wong |
Poster
Abstract #P883 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (TCE RRMM) patients in KarMMa-3 trial (phase 3 RCT): idecabtagene vicleucel (ide-cel) versus standard regimens. |
Michel Delforge |
Poster
Abstract #P905 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Treatment patterns and clinical outcomes of patients with multiple myeloma previously treated with lenalidomide and an anti-CD38 monoclonal antibody: findings from the Connect® MM disease registry. |
Rafat Abonour |
Poster
Abstract #P915 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Real-world clinical outcomes among triple-class exposed relapsed refractory multiple myeloma patients in US and |
Hartmut Goldschmidt |
Poster
Abstract #P945 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
BMS-986393 (CC-95266), a G protein–coupled receptor class C group five member D (GPRC5D)–targeted CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM): Results from a phase 1 study. |
Susan Bal |
Oral
Abstract #S193 |
Saturday, June 10, 2023
5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST) |
Idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm): a KarMMa-3 analysis in high-risk subgroups. |
Krina Patel |
Oral
Abstract #S195
|
Saturday, June 10, 2023
10:30 – 11:45 AM (4:30 – 5:45 PM CEST) |
Elotuzumab or daratumumab in combination with pomalidomide and dexamethasone (EPd and DPd) in relapsed refractory multiple myeloma (RRMM): a network meta-analysis. |
Adriana Cury |
Abstract only publication
Abstract #PB2095 |
N/A |
Myelodysplastic Syndromes |
|||
Luspatercept versus epoetin alfa for treatment (TX) of anemia in ESA-naïve patients with lower-risk myelodysplastic syndromes(LR-MDS) patients (PTS) requiring RBC transfusions: data from the COMMANDS study. |
Matteo Giovanni Della Porta |
Oral plenary and special session
Abstract #S102 |
Saturday, June 10, 2023
8:45 – 10:15 AM (2:45 – 4:15 PM CEST) |
Luspatercept restores effective erythropoiesis and provides superior and sustained benefit vs epoetin alfa: biomarker analysis from the phase 3 COMMANDS study. |
Uwe Platzbecker |
Poster
Abstract #P693 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Distinct splicing alternations associated with clinical response to luspatercept in patients with lower-risk myelodysplastic syndromes from the MEDALIST study. |
Amit Verma |
Poster
Abstract #P697 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Treatment patterns and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in routine clinical practice in |
Sudipto Mukherjee |
Poster
Abstract #P733 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
First-line treatment patterns and outcomes among patients with the newly diagnosed myelodysplastic syndromes: a global, retrospective observational cohort study. |
Amer M. Zeidan |
Abstract only publication
Abstract #PB2010 |
N/A |
Myelofibrosis |
|||
Efficacy and safety of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ACE-536-MF-001 Study. |
Francesco Passamonti
|
Oral
Abstract #S167 |
Friday, June 9, 2023
8:45 – 10:00 AM (2:45 – 4:00 PM CEST) |
Fedratinib is effective in ruxolitinib-resistant cells: clinical and preclinical correlations. |
Vikas Gupta |
Poster
Abstract #P997 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
Real-world treatment patterns and healthcare resource utilization in myelofibrosis patients with anemia. |
John Mascarenhas |
Poster
Abstract #P1059 |
Friday, June 9, 2023
12:00 – 1:00 PM (6:00 – 7:00 PM CEST) |
BMS-986158, a potent BET inhibitor, as monotherapy and in combination with ruxolitinib or fedratinib in intermediate- or high-risk myelofibrosis (MF): results from a phase 1/2 study. |
Haifa Kathrin Al-Ali
|
Oral
Abstract #S213 |
Saturday, June 10, 2023 5:30 – 6:45 AM (11:30 AM – 12:45 PM CEST) |
All EHA abstracts except late-breaking abstracts will be available on May 11. All late-breaking abstracts will be available on June 1.
Select Bristol Myers Squibb studies at the 2023 ICML Annual Meeting include:
Abstract Title |
Author |
Presentation
|
Session Title |
Session
|
Non-Hodgkin Lymphoma |
||||
CC-99282 plus R-CHOP in patients (pts) with previously untreated aggressive B-cell lymphoma (aBCL): early safety and efficacy results from a phase 1b study. |
Javier Munoz |
Poster
|
Phase I-II
|
Wednesday, June 14, 2023
6:00AM – 12:00 PM (12:00 – 6:00 PM CEST)
Thursday, June 15 – Friday, June 16, 2023
4:00 AM – 12:00 PM (10:00 AM – 6:00 PM CEST) |
Open-label phase 1/2 study of CC-99282, a cereblon E3 ligase modulator (CELMoD) agent ± rituximab, in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). |
Jean-Marie Michot |
Oral
Abstract #90 |
Session 14 Novel Agents |
Saturday, June 17, 2023
2:45 – 4:15 AM (9:45 – 10:15 AM CEST) |
Chronic Lymphocytic Leukemia |
||||
Health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in TRANSCEND CLL 004. |
S.S. Kenderian |
Poster
Abstract #400 |
CAR-T (Cellular Therapies)
|
Wednesday, June 14, 2023
6:00AM – 12:00 PM (12:00 – 6:00 PM CEST)
Thursday, June 15 – Friday, June 16, 2023
4:00 AM – 12:00 PM (10:00 AM ‒ 6:00 PM CEST) |
Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): primary analysis of TRANSCEND CLL 004. |
Tanya Siddiqi |
Oral
Abstract #26 |
Session 4 CLL and Richter Syndrome
|
Thursday, June 15, 2023
7:45 – 9:15 AM (1:45 – 3:15 PM CEST) |
Large B Cell Lymphoma |
||||
Comparison of overall survival of lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) adjusting for crossover in second-line (2L) R/R large B-cell lymphoma. |
Franck Morschhauser |
Poster
Abstract #332 |
DLBCL
|
Wednesday, June 14, 2023
6:00AM – 12:00 PM (12:00 – 6:00 PM CEST)
Thursday, June 15 – Friday, June 16, 2023
4:00 AM – 12:00 PM (10:00 AM – 6:00 PM CEST) |
Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) as second-line therapy in large B-cell lymphoma (TRANSFORM study): Subgroup analyses by prior therapy response. |
Loretta J. Nastoupil |
Oral
Abstract #138 |
Session 8 “Focus on...” Large B-Cell and Double Hit Lymphomas |
Thursday, June 15
11:00 AM – 12:00 PM (5:00 ‒ 6:00 PM CEST) |
All ICML accepted abstracts (except encore abstracts) will be available on June 9.
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 scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at 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. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.
REBLOZYL
INDICATIONS
REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell 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
Extramedullary Hematopoietic Masses
In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in
In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in
Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines. Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses.
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
Beta-Thalassemia
Serious adverse reactions occurred in
Most common adverse reactions (at least
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.
Please click here for full Prescribing Information for REBLOZYL.
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.
Important Safety Information
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
- BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
Cytokine Release Syndrome
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Among patients receiving BREYANZI for LBCL (N=418), CRS occurred in
In patients receiving BREYANZI after two or more lines of therapy for LBCL, CRS occurred in
In patients receiving BREYANZI after one line of therapy for LBCL, CRS occurred in
The most common manifestations of CRS (≥
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.
Of the 418 patients who received BREYANZI for LBCL,
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 patients receiving BREYANZI after two or more lines of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in
In patients receiving BREYANZI after one line of therapy for LBCL, CAR T cell-associated neurologic toxicities occurred in
In all patients combined receiving BREYANZI for LBCL, 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.
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-888-423-5436.
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 infusions.
In patients receiving BREYANZI for LBCL, 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 patients who received BREYANZI for LBCL, 15 of the 16 patients with a 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.
Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in
Monitor complete blood counts prior to and after BREYANZI administration.
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI.
In patients receiving BREYANZI for LBCL, hypogammaglobulinemia was reported as an adverse reaction in
Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.
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. 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.
Adverse Reactions
The most common nonlaboratory adverse reactions (incidence ≥
The most common Grade 3-4 laboratory abnormalities (≥
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
OPDIVO
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age 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 of age and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
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), 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
Immune-Mediated Hepatitis and Hepatotoxicity
OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, 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 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 US Full Prescribing Information for OPDIVO and YERVOY.
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).
IMPORTANT SAFETY INFORMATION
BOXED 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
Major Adverse Cardiac Events (MACE): Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur.
Thrombosis: Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.
Secondary Malignancies: Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
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.
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 four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
- ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Warnings and Precautions:
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA 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. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.
Fifty four percent (68/127) of patients received tocilizumab (single dose:
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.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA in
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): HLH/MAS occurred in
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 1-888-423-5436.
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. Infections (all grades) occurred in
Febrile neutropenia was observed in
Viral Reactivation: 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.
Prolonged Cytopenias: In the clinical study,
Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support.
Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adverse event 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.
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. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.
Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, 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 include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
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
Hyperthyroidism did not lead to permanent discontinuation of Opdualag. Hyperthyroidism led to withholding of Opdualag 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 <
Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other IMARs, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Other (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.
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
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 in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitation on their use, and, if approved, whether such treatments or 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, 2022, 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/20230510006079/en/
Bristol Myers Squibb
Media Inquiries:
media@bms.com
Investors:
investor.relations@bms.com
Source: Bristol Myers Squibb
