2seventy, Bristol Myers Drop Abecma Study in Newly Diagnosed Patients
By Colin Kellaher
2seventy bio and Bristol Myers Squibb are pulling the plug on a late-stage study of their Abecma gene therapy in certain people newly diagnosed with the blood cancer multiple myeloma.
2seventy on Wednesday said the companies are ending enrollment in a Phase 3 study evaluating Abecma with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who have suboptimal response to autologous stem cell transplant.
The Cambridge, Mass., company said it expects the move will conserve more than $80 million in near-term spending and accelerate its path to breakeven results next year.
2seventy said a considerably improved treatment landscape for newly diagnosed patients has resulted in considerably fewer eligible patients than when the study was first designed.
The Food and Drug Administration in 2021 approved Abecma for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, and the agency earlier this year gave a green light to expanded use of the gene therapy after two or more lines.
2seventy on Wednesday said it expects third-quarter U.S. Abecma revenue will be about 30% above second-quarter revenue of $54 million, with double-digit growth in demand.
New York-based Bristol Myers and 2seventy, a Cambridge, Mass., biotechnology company, are jointly developing and commercializing Abecma in the U.S., with Bristol responsible for manufacturing and commercialization outside of the U.S.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 25, 2024 06:45 ET (10:45 GMT)
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