Bristol Myers (BMY), TSVT CAR T-Cell Therapy to Face FDA's ODAC
Bristol Myers Squibb BMY and its partner 2seventy bio, Inc. TSVT announced that a notice was published in the Federal Register that the FDA will convene a virtual meeting of the Oncologic Drugs Advisory Committee (“ODAC”) on Mar 15, 2024, to review data supporting the supplemental biologics license application (sBLA) for Abecma (idecabtagene vicleucel).
The sBLA is seeking label expansion of Abecma for triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal phase III KarMMa-3 study. The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.
Abecma is a chimeric antigen receptor (CAR) T-cell therapy already indicated for adult patients with triple-class exposed RRMM after four or more prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. BMY and TSVT are jointly developing and commercializing Abecma in the United States.
The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared with standard regimens, significantly reducing the risk of disease progression or death versus standard regimens in patients with triple-class exposed RRMM.
Final PFS data and interim OS data from the KarMMa-3 study were presented at the 2023 American Society of Hematology Annual Meeting and Exposition in December 2023.
In November 2023, the FDA informed BMY and TSVT that the regulatory body would not be able to give a decision on the sBLA for Abecma by the original target date of Dec 16, 2023, and that ODAC will meet to review data supporting the sBLA for Abecma.
This CAR T-cell therapy was recently approved in Japan for patients with RRMM who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody based on the KarMMa-3 study.
As a result of this approval, Abecma became the first CAR T-cell therapy to receive regulatory approval for use in earlier lines of therapy for patients with relapsed and refractory multiple myeloma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency (“EMA”) also gave a positive opinion recommending Abecma’s approval for patients with triple-class exposed, relapsed and refractory multiple myeloma after at least two prior therapies.
Regulatory applications for Abecma for this patient population remain under review with the EMA and Swissmedic.
Shares of BMY have lost 20.7% in the past six months compared with no change for the industry.
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We remind investors that the FDA recently asked Gilead Sciences, Inc., Johnson & Johnson and Novartis NVS to add “boxed warning” to the labels of their T-cell immunotherapies, per Reuters.
The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies.
The FDA investigation followed reports received by the agency of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies, which resulted in not just hospitalization of patients but, in certain cases, death as well.
The agency has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies, including Abecma and BMY’s Breyanzi (lisocabtagene maraleucel).
Consequently, Novartis stated that it would update the prescribing information for its CAR-T cell therapy, Kymriah, to include instances of T-cell malignancies occurring after treatment with Kymriah. However, Novartis has not identified a causal relationship between Kymriah and secondary T-cell malignancies and remains confident about the therapy's profile.
Zacks Rank and A Stock to Consider
BMY carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Puma Biotechnology, Inc. PBYI, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained steady at 69 cents. Over the past year, shares of PBYI have gained 2.5%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
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