2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating the use of Abecma in combination with lenalidomide maintenance therapy compared to lenalidomide maintenance alone for patients with newly diagnosed multiple myeloma (NDMM) who have shown a suboptimal response to autologous stem cell transplant.
According to the company’s press release, the decision was made in response to the significantly improved treatment landscape for NDMM and an assessment of the current business case for this indication. As a result of ending the trial, 2seventy bio is expected to save approximately USD 80 million, which will alleviate financial pressures in the coming years.
Abecma, the first-in-class B-cell maturation antigen (BCMA)-directed CAR-T therapy, received its initial approval from the U.S. FDA in 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma. The therapy’s indication was expanded in April 2024 to include use after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 2seventy bio reported that this expansion is contributing to sales growth, with Q2 2024 revenues at USD 54 million, and an expected increase of around 30% in Q3. The costs and profits from Abecma in the U.S. are shared equally between BMS and 2seventy bio.- Flcube.com
