Bristol Myers Squibb BMY and its partner 2seventy bio, Inc. TSVT, a bluebird bio BLUE spinout, announced top-line data from the pivotal phase III KarMMa study evaluating Abecma (idecabtagene vicleucel) in adults with relapsed/refractory (R/R) multiple myeloma.
In 2021, bluebird bio spinoff its oncology portfolio and programs into a separate publicly-traded company, known as 2seventy bio.
The KarMMA-3 randomized study is currently evaluating Abecma against standard combination regimens for treating adults with R/R multiple myeloma after two or more prior lines of therapy and refractory to the last regimen.
Abecma was approved by the FDA in May 2021 for treating adult patients with R/R multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The KarMMA-3 study met its primary endpoint exhibiting a statistically significant improvement in progression-free survival and its key secondary endpoint of improved overall response rate.
Evaluation of another key secondary endpoint of overall survival rate after treatment with Abecma is currently in progress.
Bristol Myers and 2seventy bio will evaluate the complete data from the late-stage study and discuss results with the regulatory bodies to make Abecma available in the target market for earlier lines of treatment for patients.
Bristol Myers Shares have returned 22.9% in the year-to-date period against the industry’s decline of 17.9%.
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For Bristol Myers, Abecma is the second CAR-T cell therapy in its portfolio after Breyanzi, a differentiated CAR T cell, which was recently approved by the FDA for a label expansion.
Breyanzi was approved by the FDA in 2021 for adult patients with R/R LBCL after two or more lines of systemic therapy, including 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.
Earlier in the year, Johnson & Johnson’s JNJ Carvykti was approved by the FDA for the treatment of adult patients with R/R multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Carvykti was also approved in Europe, in May, for adults with R/R multiple myeloma after at least three lines of therapy with three major drug classes of multiple myeloma, including an immunomodulatory agent (IMiD), a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
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Bristol Myers currently has a Zacks Rank #3 (Hold).
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