Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate<\/i><\/b><\/p>\n
With these data, <\/i>Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type, the most of any CD19-directed CAR T cell therapy<\/i><\/b><\/p>\n
PRINCETON, N.J.–(BUSINESS WIRE<\/a>)–Bristol Myers Squibb<\/a> (NYSE: BMY) today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi<\/i>\u00ae<\/sup>(lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. Results showed Breyanzi<\/i> demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients.<\/p>\n \nThe study also met the key secondary endpoint of complete response rate (CRR). In the topline analysis, Breyanzi <\/i>continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed. This study marks the fifth cancer type in which Breyanzi <\/i>has demonstrated clinically meaningful benefit, representing the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy and furthering evidence of Breyanzi\u2019s <\/i>best-in-class and best-in-disease profile.<\/p>\n \n\u201cMarginal zone lymphoma is a slow-growing cancer that, for many, has a favorable prognosis. But for those patients who relapse or become refractory, the disease can be quite aggressive, and there is a need for new effective and tolerable treatment options to address this unmet critical need,\u201d said Rosanna Ricafort, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy, Bristol Myers Squibb. \u201cWe are pleased that the TRANSCEND FL study supports the potential of Breyanzi <\/i>in marginal zone lymphoma and look forward to presenting detailed results from the study at an upcoming medical meeting.\u201d<\/p>\n \nBristol Myers Squibb thanks the patients and investigators who are participating in the TRANSCEND FL clinical trial.<\/p>\n About TRANSCEND FL About MZL About Breyanzi Breyanzi<\/i> is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (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 at least 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 <\/i>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, and in Japan for the treatment of relapsed or refractory patients with high-risk follicular lymphoma after one prior line of systemic therapy and in patients after two or more lines of systemic therapy.<\/p>\n \nBristol Myers Squibb\u2019s clinical development program for Breyanzi<\/i> includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov<\/a>.<\/p>\n U.S. FDA-Approved Indications Limitations of Use<\/span>: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.<\/p>\n Important Safety Information Cytokine Release Syndrome \nSerious 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).<\/p>\n \nEnsure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.<\/p>\n Neurologic Toxicities<\/b><\/p>\n \nNeurologic 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.<\/p>\n \nIn clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including \u2265 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.<\/p>\n \nThe most common neurologic toxicities (\u22655%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.<\/p>\n CRS and Neurologic Toxicities Monitoring<\/b><\/p>\n \nMonitor 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.<\/p>\n BREYANZI REMS<\/b><\/p>\n \nBecause 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:<\/p>\n \nFurther information is available at www.BreyanziREMS.com<\/a>, or contact Bristol Myers Squibb at 1-866-340-7332.<\/p>\n Hypersensitivity Reactions<\/b><\/p>\n \nAllergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).<\/p>\n Serious Infections<\/b><\/p>\n \nSevere 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.<\/p>\n \nFebrile 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.<\/p>\n \nMonitor 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.<\/p>\n \nViral 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.<\/p>\n Prolonged Cytopenias<\/b><\/p>\n \nPatients 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.<\/p>\n Hypogammaglobulinemia<\/b><\/p>\n \nB-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.<\/p>\n \nLive 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.<\/p>\n Secondary Malignancies<\/b><\/p>\n \nPatients 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.<\/p>\n Effects on Ability to Drive and Use Machines<\/b><\/p>\n \nDue 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.<\/p>\n Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)<\/b><\/p>\n \nImmune 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.<\/p>\n Adverse Reactions<\/b><\/p>\n \nThe most common adverse reaction(s) (incidence \u226530%) in:<\/p>\n Please see full <\/b>Prescribing Information<\/b><\/a>, including Boxed WARNINGS and <\/b>Medication Guide<\/b><\/a>.<\/b><\/p>\n Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy<\/span><\/b><\/p>\n \nA pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.<\/p>\n \nBristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy\u2019s transformational potential.<\/p>\n \nThe building blocks to realize this ambition\u2014a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities\u2014are in our cells.<\/i> We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here<\/a>.<\/p>\n About Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements \ncorporatefinancial-news<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250207490270\/en\/<\/a><\/span><\/p>\n Bristol Myers Squibb<\/b><\/p>\n Media Inquiries:
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<\/span><\/b>TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi <\/i>in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.<\/p>\n
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<\/span><\/b>Marginal zone lymphoma (MZL) is the second most common, slow-growing form of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases. Most patients with MZL are at a median age of 67 when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person\u2019s lymph nodes or organs. MZL presents in three main forms: extranodal, which affects the gastrointestinal tract, skin, and lung, comprising 60% of cases; nodal, involving the lymph nodes, 30%; and splenic, involving the spleen, 10%. Initial therapy often leads to long remissions, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma.<\/p>\n
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<\/i><\/span><\/b>Breyanzi is <\/i>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 <\/i>is made from a patient\u2019s 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.<\/p>\n
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<\/span><\/b>BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:<\/p>\n\n
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<\/span><\/b>WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES<\/b><\/p>\n\n
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<\/b>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 \u2265 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 (\u226510%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.<\/p>\n\n
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<\/span><\/b>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<\/a> or follow us on LinkedIn<\/a>, X<\/a>, YouTube<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n
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<\/span><\/b>This press release contains \u201cforward-looking statements\u201d 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,<\/i>that future study results may not be consistent with the results to date, that <\/i>Breyanzi (lisocabtagene maraleucel), may not receive regulatory approval for the additional indication, described in this release, in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether <\/i>Breyanzi for such indication 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\u2019s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb\u2019s 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.<\/i><\/p>\n<\/p>\n
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