PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced data from three studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzi as a second-line treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL), results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trial in relapsed or refractory follicular lymphoma (FL).
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 U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory FL who have received two or more prior lines of systemic therapy. The FDA also granted Breyanzi approval for patients with relapsed or refractory MCL who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor, expanding its use to include four distinct types of B-cell lymphomas.
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 (95% CI: 9.5-NR) compared to 2.4 months with SoC (95% CI: 2.2-4.9) (HR: 0.375; 95% CI: 0.259-0.542). The 36-month EFS rate with Breyanzi was 45.8% (95% CI: 35.2-56.5) vs. 19.1% (95% CI: 11.0-27.3) for SoC. The overall response rate (ORR) with Breyanzi was 87% (95% CI: 78.3-93.1) with 74% of patients achieving a complete response (CR) (95% CI: 63.7-82.5) vs. a 49% (95% CI: 38.3-59.6) ORR with SoC and a 43% (95% CI: 33.2-54.2) CR rate. DOR was not reached with Breyanzi (95% CI: 16.9-NR) and was 9.1 months with SoC (95% CI:.1-NR) (HR:0.603; 95% CI: 0.364.1.000). Additionally, PFS was not reached with Breyanzi (95% CI: 12.6-NR) vs. 6.2 months (95% CI: 4.3-8.6) for SoC (HR: 0.422; 95% CI: 0.279-0.639). The 36-month PFS rate for Breyanzi was 50.9% (95% CI: 39.9-62.0) and was 26.5% (95% CI: 15.9-37.1) with SoC.
“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 (66%) in the SoC arm crossed to receive Breyanzi. With longer follow-up, median overall survival (OS) was not reached for either arm, and the 36-month OS rate was numerically higher for Breyanzi (62.8% [95% CI: 52.7-72.9] vs. 51.8% [95% CI: 41.2-62.4]) (HR: 0.757; 95% CI: 0.481-1.191).
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; 93%) and patients who did not receive bridging therapy (n=79; 99%). CR rates were consistently high across both subgroups (93% in bridging therapy and 95% in non-bridging therapy), with all patients who received bridging therapy and responded to Breyanzi treatment achieving CR. Median DOR, PFS, and OS were not reached in either subgroup, with a median follow-up of 18.9 months. Breyanzi exhibited a consistent safety profile across both groups, with low rates of any-grade CRS (51% in bridging therapy subgroup and 62% in non-bridging therapy subgroup) and any-grade NEs (12% in bridging therapy subgroup and 17% in non-bridging therapy subgroup). Grade 3 CRS (0% vs 1%), NEs (6% vs 0%) and infections (2% vs 7%) were similarly low across subgroups, with no Grade 4 or 5 events.
“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 3% of all NHL cases. MCL originates from cells in the “mantle zone” of the lymph node. MCL occurs more frequently in older adults with an average age at diagnosis in the mid-60s, and it is more often found in males than in females. In MCL, relapse after initial treatment is common, and for most, the disease eventually progresses or returns.
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 U.S. for the treatment of relapsed or refractory LBCL after at least one prior line of therapy, and for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after two prior lines of therapy, and for the treatment of relapsed or refractory follicular lymphoma in adult patients who have received two or more prior lines of systemic therapy, and for the treatment of relapsed or refractory mantle cell lymphoma in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Breyanzi is also approved in Japan and Europe for the second-line treatment of relapsed or refractory LBCL, and in Japan, Europe, Switzerland and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.
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:
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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 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.
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 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.
The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.
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 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.
Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.
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 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.
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 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. 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. 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 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.
Adverse Reactions
The most common adverse reaction(s) (incidence ≥30%) in:
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.
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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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