bluebird bio, Inc. (BLUE - Free Report) and partner Bristol-Myers Squibb Company (BMY - Free Report) announced positive top-line results from a phase II study on their lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate, idecabtagene vicleucel (ide-cel; bb2121).
The phase II KarMMa study evaluated the efficacy and safety of idecabtagene vicleucel in patients with relapsed and refractory multiple myeloma. The study met its primary endpoint and key secondary endpoint demonstrating deep and durable responses in a heavily pre-treated multiple myeloma patient population.
In the study, all treated patients were exposed to at least three prior therapies, including an immunomodulatory (IMiD) agent, a proteasome inhibitor (PI) and an anti-CD38 antibody, and all were refractory to their last regimen. Of these patients, 94% were refractory to an anti-CD38 antibody and 84% were triple refractory to an IMiD agent, PI, and anti-CD38 antibody.
Overall, the safety results were consistent with those observed in the phase I CRB-401 study, which evaluated the preliminary safety and efficacy of ide-cel.
The company is preparing for the submission of these data to Health Authorities for the proposed initial registration of ide-cel as a first-in-class B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy.
Ide-cel is being developed as part of a co-development, co-promotion and profit share agreement between bluebird and Bristol-Myers.
In November 2017, ide-cel was granted the Breakthrough Therapy designation by the FDA and PRIority Medicines (PRIME) eligibility by the European Medicines Agency based on preliminary clinical data from the phase 1 CRB-401 study.
Shares of bluebird have declined 19.9% year to date against the industry’s growth of 6.6%.
Zacks Rank & Stocks to Consider
bluebird currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.
Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.
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