Bristol Myers Squibb’s Breyanzi Demonstrates Clinically Meaningful Outcomes Across Broad Range of B-Cell Malignancies in New Data Presented at 2024 ASCO® Annual Meeting
Bristol Myers Squibb's Breyanzi has shown significant clinical benefits for patients with various B-cell malignancies, according to new data presented at the 2024 ASCO Annual Meeting. The three-year follow-up from the Phase 3 TRANSFORM trial demonstrates sustained event-free survival and durable responses in patients with large B-cell lymphoma (LBCL), outperforming standard care.
The study also highlights Breyanzi's consistent efficacy and safety in mantle cell lymphoma (MCL) and follicular lymphoma (FL) across different subgroups, regardless of the number of prior treatments or use of bridging therapy. This underscores Breyanzi's potential for earlier lines of treatment and relapsed or refractory cases. Recently, the FDA granted accelerated approval for Breyanzi in relapsed or refractory FL and MCL, expanding its use across four types of B-cell lymphomas.
These findings emphasize Breyanzi's role as a transformative CAR T cell therapy with a robust clinical profile, offering hope for improved patient outcomes.
- Breyanzi demonstrates a 36-month event-free survival rate of 45.8% compared to 19.1% with standard care.
- Overall response rate (ORR) with Breyanzi is 87%, with 74% achieving a complete response.
- Progression-free survival (PFS) with Breyanzi not reached, indicating sustained benefits.
- FDA accelerated approval for Breyanzi in relapsed or refractory FL and MCL, expanding its indication.
- Consistent efficacy and safety profile across various subgroups and prior lines of therapy.
- High response rates in follicular lymphoma regardless of prior bridging therapy.
- Low rates of severe cytokine release syndrome and neurologic events.
- Breyanzi demonstrates durable responses and improved event-free survival compared to standard care.
- High costs associated with CAR T cell therapies like Breyanzi may limit accessibility.
- The treatment still poses risks of severe cytokine release syndrome and neurologic toxicities.
- Median overall survival not reached in the TRANSFORM trial, indicating a need for longer-term follow-up.
- In some subgroups, Breyanzi showed numerically shorter duration of response in heavily-pretreated patients.
- CRS occurred in 54% of patients, with ≥ Grade 3 CRS in 3.2% of patients.
- Neurologic toxicities, including serious events like cerebral edema and seizures, occurred in 31% of patients.
- Potential for secondary malignancies following treatment with Breyanzi.
Insights
The data reported from the TRANSFORM, TRANSCEND NHL 001 and TRANSCEND FL trials indicate that Breyanzi continues to show significant clinical benefits across various forms of B-cell malignancies. The three-year follow-up results from the TRANSFORM study are especially noteworthy, as they demonstrate prolonged event-free survival (EFS) and durable responses, which are critical for patients with relapsed or refractory large B-cell lymphoma (LBCL). These findings underscore Breyanzi’s potential as a transformative therapy and support its use earlier in the treatment paradigm.
The subgroup analyses from the MCL cohort of TRANSCEND NHL 001 and TRANSCEND FL further strengthen the case for using Breyanzi in a broad patient population. Specifically, the consistent efficacy regardless of the number of prior lines of therapy in the MCL cohort and the high response rates in the FL cohort, irrespective of bridging therapy status, highlight the versatility and robustness of Breyanzi.
For retail investors, these results suggest a promising outlook for Breyanzi in the CAR T cell therapy market. The long-term benefits and consistent safety profile could potentially translate into steady market adoption and revenue growth for Bristol Myers Squibb.
From a market perspective, the robust clinical data supporting Breyanzi's efficacy and safety across multiple B-cell malignancies positions Bristol Myers Squibb well in the competitive field of CAR T cell therapies. The recent FDA accelerated approvals for Breyanzi in relapsed or refractory follicular lymphoma (FL) and mantle cell lymphoma (MCL) expand its market reach and could drive significant revenue growth.
Breyanzi's differentiated profile, particularly its consistent performance irrespective of prior treatments, is a strong selling point. For retail investors, this suggests that Breyanzi could capture a larger market share, especially among patients who have exhausted other treatment options. The long-term data also implies a sustainable competitive advantage over other CAR T cell therapies, which may not have such extensive follow-up results.
However, potential investors should be mindful of the risks associated with CAR T cell therapies, including the high costs and the complex manufacturing process. Additionally, the safety concerns, such as cytokine release syndrome (CRS) and neurologic toxicities, though well-managed, could limit patient uptake or require additional investments in patient monitoring and care infrastructure.
The financial implications of the presented data for Breyanzi are quite positive. The long-term follow-up results from the TRANSFORM study showing significant improvements in event-free survival (EFS) and progression-free survival (PFS) against standard of care (SoC) suggest a strong potential for increased adoption and sales. The overall response rate (ORR) and complete response (CR) rates are impressive and position Breyanzi as a leading treatment option in its category.
The FDA's recent accelerated approvals for additional indications expand the potential market size for Breyanzi significantly. For investors, this means potential near-term revenue growth and enhanced market penetration. The consistent safety profile and the lack of new safety signals further reduce the risk of market withdrawal or restrictions, which is a positive factor for long-term financial stability.
Given the competitive landscape in CAR T cell therapies, Breyanzi's differentiated performance could lead to increased pricing power and better negotiation leverage with payers. However, investors should also consider the high costs associated with CAR T therapies and the potential need for additional post-marketing studies, which could impact margins.
Three-year follow-up results from TRANSFORM show ongoing event-free survival and durable responses with Breyanzi compared to standard of care
Results from a subgroup analysis from mantle cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi demonstrated consistent clinical benefit regardless of number of prior lines of therapy, supporting use of Breyanzi in earlier lines of treatment
Data from bridging therapy subgroup analysis of TRANSCEND FL show consistent efficacy with high response rates and a consistent safety profile regardless of receiving prior bridging therapy, supporting Breyanzi’s differentiated profile in relapsed or refractory follicular lymphoma
The data, presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, underscore Breyanzi as a transformative therapy with demonstrated clinically meaningful outcomes across the broadest array of B-cell malignancies.
Results from the primary analysis of TRANSCEND FL were simultaneously published in Nature Medicine.
“This year’s ASCO is another exciting moment in the cascade of milestones for Breyanzi, our differentiated CAR T cell therapy approved for the broadest range of B-cell malignancies of any CAR T cell therapy,” said Anne Kerber, M.D., senior vice president, head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “The new data being presented from our vast clinical development program are an incredible showcase of the improved outcomes and consistent safety profile Breyanzi provides for patients with diverse types of lymphomas, offering a definitive therapy with demonstrated improved outcomes, and we remain dedicated to leading the advancement of innovative therapies to improve outcomes for a wide range of patients.”
Notably, Breyanzi was recently granted accelerated approval by the
Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
Long-Term Results from TRANSFORM (Abstract #7013)
In the pivotal, global, randomized, multicenter, Phase 3 TRANSFORM study, 184 patients with primary refractory LBCL or relapsed disease within <12 months after first-line therapy who were eligible for autologous hematopoietic stem cell transplant (HSCT) were randomized to receive Breyanzi (n=92) or salvage chemotherapy followed by high-dose chemotherapy and autologous HSCT (standard of care, SoC; n=92).
With a median follow-up of 33.9 months, Breyanzi demonstrated sustained significant clinical benefit with continued improvements in the primary endpoint of event-free survival (EFS), and secondary endpoints of progression-free survival (PFS), overall responses and duration of response (DOR) compared to SoC, consistent with the primary analysis results.
With longer follow-up, EFS with Breyanzi was 29.5 months (
“The long-term data from TRANSFORM builds upon the remarkable results from the primary analysis, with liso-cel continuing to demonstrate deep and durable responses and improved event-free and progression-free survival along with a well-established safety profile,” said Manali Kamdar, M.D., lead investigator of the TRANSFORM study and Associate Professor, Clinical Director of Lymphoma Services, Division of Hematology, Hematologic Malignancies and Stem Cell Transplantation, University of Colorado Cancer Center. “This sustained clinical benefit with a median follow-up of three years is extremely meaningful for patients with relapsed or refractory LBCL, and the results reinforce the value of using a CAR T cell therapy such as liso-cel earlier in the treatment paradigm.”
In the patient-centric trial, which allowed for crossover, 61 patients (
Additionally, Breyanzi continued to demonstrate a consistent safety profile with no new safety signals observed.
Results from Subgroup Analyses from the MCL Cohort of TRANSCEND NHL 001 (Abstract #7016) and TRANSCEND FL (Abstract #7068)
The MCL cohort of TRANSCEND NHL 001 enrolled adults with relapsed or refractory disease after two or more prior lines of therapy, including a BTK inhibitor. In a subgroup analysis reporting outcomes for patients treated with Breyanzi by number of prior lines of therapy and response to prior BTK inhibitor, Breyanzi showed similar efficacy across most subgroups based on overall responses (ORR), complete responses (CR), median duration of response (DOR), progression-free survival (PFS) and overall survival (OS), including in heavily-pretreated patients. The greatest benefit was observed in patients who had received 2-4 prior lines of therapy. Numerically shorter DOR was observed in patients who had received >5 prior lines of therapy and those whose disease was refractory to prior treatment with a BTK inhibitor. The safety profile of Breyanzi was consistent across subgroups and well-tolerated with low rates of severe cytokine release syndrome (CRS) and neurologic events (NE).
The subgroup analysis for TRANSCEND FL in second-line plus relapsed or refractory FL, including second-line high-risk FL, assessed outcomes in patients by bridging therapy status. The primary endpoint of ORR was similar in patients who received bridging therapy (n=45;
“The subgroup analyses from the MCL cohort of TRANSCEND NHL 001 and TRANSCEND FL further demonstrate liso-cel's potential as a treatment option for a broad patient population with relapsed or refractory MCL or FL,” said M. Lia Palomba, M.D., TRANSCEND investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “In relapsed or refractory MCL, liso-cel demonstrated clinically meaningful and durable disease control across subgroups, including in earlier lines of treatment where there remains a critical unmet need. Additionally, results from the subgroup analysis from TRANSCEND FL show the consistent clinical benefit of using liso-cel for relapsed or refractory FL with or without prior bridging therapy, with high response rates regardless of bridging status, further expanding the use of liso-cel for these patients.”
About TRANSFORM
TRANSFORM (NCT03575351) is a pivotal, global, randomized, multicenter Phase 3 trial evaluating Breyanzi compared to current standard therapy regimens (platinum-based salvage chemotherapy followed by high-dose chemotherapy and HSCT in patients responding to salvage chemotherapy) in patients with large B-cell lymphoma (LBCL) that was primary refractory or relapsed within 12 months after CD20-antibody and anthracycline containing first-line therapy. Patients were randomized to receive Breyanzi or standard of care salvage therapy, including rituximab plus dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP), rituximab plus ifosfamide, carboplatin and etoposide (R-ICE), or rituximab plus gemcitabine, dexamethasone and cisplatin (R-GDP) per the investigators’ choice before proceeding to high-dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). The primary endpoint of the study was event-free survival (EFS), defined as time from randomization to death from any cause, progressive disease, failure to achieve complete response or partial response, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first. Complete response (CR) rate was a key secondary endpoint. Other efficacy endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and duration of response (DOR).
About TRANSCEND NHL 001
TRANSCEND NHL 001 (NCT02631044) is an open-label, multicenter, pivotal, Phase 1, single-arm, seamless-design study to determine the safety, pharmacokinetics and antitumor activity of Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), including diffuse LBCL, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma (FL) Grade 3B and mantle cell lymphoma (MCL). The primary outcome measures are treatment-related adverse events, dose-limiting toxicities and overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell NHL, including FL. The primary outcome measure is ORR, including best overall response of complete response or partial response as determined by an Independent Review Committee. Secondary outcome measures include CR rate, DOR, PFS, and safety.
About LBCL
LBCL refers to several subtypes of NHL, with diffuse large B-cell lymphoma (DLCBL) being the most common and aggressive form of the disease. Large B-cell lymphomas are cancers that start in the lymphocytes and affect immune cells called B lymphocytes, which are a type of white blood cell. LBCL accounts for about one out of every three cases of NHL, and occurs most often in older people, with a median age of 66 at diagnosis. Survival may vary depending on prognostic factors such as age, general health and stage of disease.
About MCL
MCL is an aggressive, rare form of NHL, representing roughly
About FL
FL is the second most common form of NHL and the most common subtype of indolent NHL, accounting for 20 to 30 percent of all NHL cases. Most patients with FL are over 50 years of age when they are diagnosed. FL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. It is characterized by periods of remission and relapse, and the disease becomes more difficult to treat after relapse or disease progression.
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
Breyanzi is approved in the
Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov.
Indications
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).
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Important Safety Information
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES
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.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
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. In clinical trials of BREYANZI, which enrolled a total of 702 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, 35 of 38 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. 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 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-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (
Adverse Reactions
The most common adverse reaction(s) (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 is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
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.
Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.
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, whether Breyanzi (lisocabtagene maraleucel) for the additional indication described in this release will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Breyanzi for such additional indication described in this release may be contingent upon verification and description of clinical benefit in confirmatory trials. 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.
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FAQ
What are the key findings from the Phase 3 TRANSFORM trial for Breyanzi (BMY)?
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What are the safety concerns associated with Breyanzi treatment?
Has Breyanzi received FDA approval for any new indications recently?
What is the significance of the new data presented at ASCO 2024 for Breyanzi (BMY)?
