Bristol Myers-2seventy Bio Halt Phase 3 Trial For Abecma In Newly Diagnosed Myeloma Patients, Speeds Path To Profitability

2seventy bio, Inc TSVT and its partner Bristol Myers Squibb & Co BMY, will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study of Abecma (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone for newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.

"Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80 million in near-term expenditures and accelerate our path to breakeven in 2025," said Chip Baird, CEO of 2seventy bio.

Also Read: FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer.

2seventy also reported continued positive momentum in Abecma's expected return to growth in the earlier line setting following the FDA's approval in April 2024.

The company expects third-quarter Abecma U.S. revenue growth of approximately 30% from second-quarter revenue of $54 million. Demand, as measured by new patients undergoing apheresis in the third quarter, is also expected to reflect double-digit growth compared to the second quarter of 2024.

William Blair says while expectations for Abecma are generally low for investors at this point, the ability to maximize the opportunity in the current label would offset concerns about the fixed costs of the cell therapy franchise.

2seventy bio and BMS share equally in all profits and losses related to the development, manufacturing, and commercialization of Abecma in the U.S.

Overall, the announcement suggests moving CAR-T therapies into the earliest lines of treatment may have headwinds given the strong current standard of care. Therefore, we think thoughtful trial designs that reflect the changing standard of care will have the greatest potential of maximizing the CAR-T total addressable market."

Recently, Novo Nordisk A/S NVO acquired the Hemophilia A program and rights to 2seventy's in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease.

2seventy bio will focus exclusively on the commercialization and continued development of Abecma.

Price Action: TSVT stock is down 7.65% at $4.41, and BMY stock is down 2.90% at $49.47 at last check Wednesday.

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