2seventy bio, Inc. (TSVT) and its partner Bristol Myers Squibb (BMY) have made the decision to halt enrollment in their ongoing Phase 3 KarMMa-9 study. This study focused on evaluating the effectiveness of Abecma (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance compared to lenalidomide maintenance alone for newly diagnosed multiple myeloma (NDMM) patients who have suboptimal response to autologous stem cell transplant.
The decision to discontinue enrollment was driven by a strategic focus on capital allocation and maximizing value for stakeholders. As explained by Chip Baird, CEO of 2seventy bio, “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.”
Despite the discontinuation of the KarMMa-9 study, 2seventy bio remains optimistic about the future of Abecma. The company is seeing positive momentum in Abecma’s performance in earlier line settings, following the FDA’s approval in April 2024 for earlier use in pretreated blood cancer patients. This momentum is expected to translate into significant revenue growth, with the company projecting a 30% increase in Abecma’s U.S. revenue in the third quarter compared to the second quarter.
Further, 2seventy bio reports strong demand for Abecma, with double-digit growth in new patients undergoing apheresis in the third quarter compared to the second quarter of 2024. While investor expectations for Abecma remain relatively low at this point, William Blair believes that maximizing the drug’s opportunity within its current label could offset concerns about the fixed costs associated with the cell therapy franchise.
It’s important to note that 2seventy bio and BMS share equally in all profits and losses related to the development, manufacturing, and commercialization of Abecma in the U.S. The decision to discontinue the KarMMa-9 study suggests that moving CAR-T therapies into earlier lines of treatment might face challenges due to the existing strong standard of care.
In recent developments, Novo Nordisk A/S (NVO) acquired the Hemophilia A program and rights to 2seventy’s in vivo gene editing technology outside of oncology. This acquisition excludes gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease. As a result of this transaction, 2seventy bio will now focus exclusively on the commercialization and continued development of Abecma.
The announcement of the study discontinuation resulted in a decrease in stock prices for both TSVT and BMY. As of Wednesday’s close, TSVT stock was down 7.65% at $4.41, while BMY stock was down 2.90% at $49.47.
