2seventy bio, Bristol Myers halt late-stage Abecma study in multiple myeloma over recruitment issues

2seventy bio and partner Bristol Myers Squibb announced the discontinuation of enrollment in the Phase 3 KarMMa-9 study, which was examining the efficacy of Abecma in patients newly diagnosed with multiple myeloma. The decision follows a detailed business review and reflects significant improvements in treatment options for newly diagnosed patients, according to 2seventy CEO Chip Baird.

Bristol Myers Squibb, in a separate statement, highlighted challenges in patient enrollment due to advancements in induction therapies, which reduced the number of eligible participants for the study. Despite being active for over a year across 18 countries, only 10% of the target enrollment had been achieved. The trial aimed to recruit 618 patients, as noted on ClinicalTrials.gov.

The termination of the trial is projected to support 2seventy's financial goals, enabling the company to break even by next year. CEO Baird emphasized that this strategic move aligns with their focus on efficient capital allocation and value creation for stakeholders. He anticipates the decision will save over $80 million in immediate costs, expediting the company's breakeven timeline to 2025.

The KarMMa-9 study was evaluating Abecma, a CAR-T therapy, in conjunction with lenalidomide maintenance, against lenalidomide maintenance alone. The target population was patients with newly diagnosed multiple myeloma who had not responded optimally to an autologous stem cell transplant.

Earlier this year, the FDA granted expanded approval for Abecma in a third-line setting, building on its initial approval for use in fifth-line patients. This came despite earlier concerns about a higher mortality rate in patients receiving Abecma compared to those on standard treatment regimens. Nonetheless, Baird noted that Abecma has shown positive growth and a promising safety profile, particularly with the extended label in the third line.

2seventy bio also projected a 30% increase in Abecma revenue in the US for the third quarter of 2024, up from $54 million in the second quarter.