Data from Phase 2 PILOT Study of Bristol Myers Squibb’s CAR T cell Therapy Breyanzi Show Substantial Durable Responses in Patients with Refractory or Relapsed Large B-cell Lymphoma After First-Line Therapy

First disclosure of results from primary analysis of Phase 2 PILOT study shows Breyanzi delivered complete responses in more than half of patients with refractory or relapsed large B-cell lymphoma after first-line therapy who were not deemed candidates for stem cell transplant

PILOT patient-reported outcomes analysis showed treatment with Breyanzi improved health-related quality of life measures for patients

Breyanzi is the only CAR T cell therapy that has been evaluated in two distinct trials in the second-line setting for large B-cell lymphoma, underscoring its value, if approved, as an important treatment option after failure of first-line therapy

PRINCETON, NJ, USA I May 26, 2022 I Bristol Myers Squibb (NYSE: BMY) today announced results from the primary analysis of PILOT, a multicenter, Phase 2 study evaluating Breyanzi (lisocabtagene maraleucel) in adults with refractory or relapsed large B-cell lymphoma (LBCL) after first-line therapy who were not deemed candidates for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT). The PILOT study is the only company-sponsored trial to evaluate a CAR T cell therapy as a second-line treatment for patients with relapsed or refractory LBCL who are not considered candidates for stem cell transplant. The data will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 4 from 9:00 AM – 12:00 PM EDT (ABSTRACT 7062).

The PILOT study enrolled a broad patient population of adults with refractory or relapsed LBCL after first-line treatment who were not considered candidates for transplant based on age, performance status and/or organ function and comorbidities, and regardless of time to relapse following first-line treatment. With a median follow-up of 12.3 months, the majority of patients treated with Breyanzi (n=61) saw a reduction in disease, with 80% of patients responding to treatment (overall response rate; 95% CI: 68.2 – 89.4) and 54% of patients achieving a complete response (CR; 95% CI:40.8-66.9). Responses with Breyanzi were durable, with a median duration of response of 12.1 months (95% CI: 6.2-NR) at 15.5 months median follow-up. In patients who achieved a CR, median duration of response was 21.7 months (95% CI: 12.7-NR). Median progression-free survival with Breyanzi was 9.0 months (95% CI: 4.2-NR), and median overall survival has not been reached (95% CI: 17.3-NR). In the PILOT study, patients were treated with Breyanzi and monitored in both the inpatient and outpatient setting.

“For patients with large B-cell lymphoma that is refractory to or relapses after first-line therapy, stem cell transplant has been the only potentially curative treatment option, but the reality is many patients are not candidates for stem cell transplant, leaving limited treatment options,” said Leo I. Gordon, M.D., study investigator, Professor in Medicine, Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois. “The results from the PILOT study, including the patient-reported outcomes, show that treatment with liso-cel as a second-line therapy offers durable responses with improved quality of life for patients who historically have had poor prognosis.”

LBCL, the most common type of non-Hodgkin lymphoma, is an aggressive blood cancer and approximately 40% of patients will have disease that is refractory to or relapses after first-line treatment. High-dose chemotherapy followed by autologous stem cell transplant has been the mainstay of care in the second-line setting; however, less than half of patients with primary refractory or relapsed disease are considered candidates for a stem cell transplant. For these patients, there are limited treatments that provide long-term disease control and palliative care is often the only option. If left untreated, patients with relapsed or refractory LBCL have a life expectancy of just three to four months.

“At Bristol Myers Squibb, we strive for cure by advancing innovative therapies that may provide long-term clinical benefit for some of the most challenging cancers with the hope of creating new standards of care that not only improve outcomes but also the patient experience,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “With Breyanzi, we have boldly designed a broad clinical trial program in relapsed or refractory LBCL, including patients who are not intended for stem cell transplant after failure of first-line therapy. These results from the PILOT study continue to demonstrate the practice-changing potential of Breyanzi in this setting, delivering on the promise of CAR T cell therapy for more patients.”

In the PILOT study, Breyanzi showed a manageable safety profile with no new safety signals and low rates of severe cytokine release syndrome (CRS) or neurologic events, and no Grade 4/5 CRS or neurologic events reported. Any grade CRS occurred in 38% of patients, with Grade 3 CRS reported in one patient (2%). Any grade neurologic events were seen in 31% of patients with Grade 3 neurologic events reported in three patients (5%).

In a separate analysis of patient-reported outcomes (PRO) from the PILOT study, patients who received Breyanzi and were evaluable for the PRO analysis (n=56) showed significant improvements in fatigue and pain. Improvements in overall lymphoma symptoms were clinically meaningful following treatment with Breyanzi, and in an individual patient-level analysis, 70% of patients reported meaningful improvements in quality of life based on FACT-LymS scores at month 6. Results from the analysis will be presented in a poster presentation on Monday, June 6 from 2:15 PM – 5:15 PM EDT (Abstract 6567).

A supplemental Biologics License Application for Breyanzi for the treatment of relapsed or refractory LBCL after failure of first-line therapy is currently under Priority Review with the U.S. Food and Drug Administration (FDA), with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 24, 2022.

Breyanzi, a differentiated CD-19 directed CAR T cell therapy, is currently approved by the FDA for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, 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. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

About Breyanzi

Breyanzi is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy, administered as a defined composition to reduce variability of the CD8 and CD4 component dose. Breyanzi has a 4-1BB costimulatory domain which enhances the expansion and persistence of the CAR T cells. Breyanzi was previously approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, 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. Breyanzi is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.

Breyanzi is also approved in the European Union, Switzerland, Japan 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 earlier lines of treatment for patients with relapsed or refractory LBCL and other types of lymphomas and leukemia. For more information, visit clinicaltrials.gov.

Breyanzi is not approved in any region for the second-line treatment of LBCL.

About PILOT

PILOT (NCT03483103) is a multicenter Phase 2 trial evaluating Breyanzi as a second-line therapy in adults with relapsed or refractory large B-cell lymphoma after first-line therapy who are ineligible for hematopoietic stem cell transplant (HSCT). All enrolled patients have relapsed or refractory large B-cell lymphoma after treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent and have been deemed non-candidates for high-dose chemotherapy and HSCT. The primary endpoint of the study is overall response rate. Other efficacy endpoints include complete response rate, duration of response, progression-free survival, event-free survival and overall survival.

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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.

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.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

SOURCE: Bristol Myers Squibb

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