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Bristol Myers (BMY) Announces Data on CAR T Cell Therapy Breyanzi

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Bristol Myers Squibb BMY announced positive top-line results from the TRANSFORM study on Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy.

Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy. It was approved in February 2021 for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma 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.

The TRANSFORM study has been designed to evaluate Breyanzi’s potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard-of-care regimen of high-dose chemotherapy and autologous stem-cell transplant.

The results of a pre-specified interim analysis conducted by an independent review committee showed that the study met its primary endpoint. Data showed a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care. The safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting.

Bristol Myers will complete an evaluation of the TRANSFORM data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities.

Bristol-Myers’ shares have gained 7.9% year to date against the industry's decline of 1.9%.

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Zacks Investment Research

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The company’s performance in the first quarter of 2021 was dismal as immuno-oncology drug Opdivo’s sales declined as competition is stiff from the likes of Merck’s MRK Keytruda. Moreover, Revlimid sales weren’t impressive either.

Nevertheless, the recent approval of new drugs adds a new stream of revenues, which should propel growth in the coming quarters.

In March, the company and partner bluebird bio, Inc. BLUE obtained the FDA approval for Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory MM.

Last month, the FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes Repligen Corporation RGEN, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 90 days.

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Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report

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Repligen Corporation (RGEN) : Free Stock Analysis Report

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