2seventy bio Updates KarMMa-9 Study, Previews Strong Q3 Revenue

CAMBRIDGE, Mass.--2seventy bio, Inc. (Nasdaq: TSVT) announced the termination of patient enrollment in the Phase 3 KarMMa-9 study, conducted with Bristol Myers Squibb (BMS), that evaluated Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance against lenalidomide maintenance alone for patients with newly diagnosed multiple myeloma (NDMM) who had an insufficient response to autologous stem cell transplant.

Chip Baird, CEO of 2seventy bio, explained that the evolution of NDMM treatment options and a thorough business assessment led to the decision to halt the KarMMa-9 study. He emphasized that Abecma remains a promising treatment, particularly with its expanded third-line label and distinctive safety profile. The termination is expected to save over $80 million in immediate expenses and expedite the company's journey towards profitability by 2025. Baird underscored the company’s ongoing commitment to maximizing business growth while staying focused on improving patient outcomes.

Despite the discontinuation of KarMMa-9 enrollment, 2seventy bio and BMS remain dedicated to expanding Abecma's reach among multiple myeloma patients. Anna Truppel-Hartmann, Chief Medical Officer at 2seventy bio, acknowledged the improvements in NDMM treatment, such as the adoption of quadruplet therapy induction and enhanced consolidation therapies, which have reduced the pool of eligible patients for the study. She thanked the trial participants and the medical professionals involved, highlighting the company’s dedication to addressing high unmet needs in patient care.

In terms of commercial progress, 2seventy bio reported positive momentum for Abecma, anticipating a 30% revenue growth in the U.S. for the third quarter of 2024 compared to the second quarter's $54 million. This growth is credited to the increasing number of new patients undergoing apheresis. The company remains optimistic about Abecma's success in earlier treatment lines and continues its commitment to the product's market performance.

Abecma, developed jointly by 2seventy bio and BMS, is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy. It is intended for treating adults with relapsed or refractory multiple myeloma after at least two prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The safety profile of Abecma includes serious risks such as Cytokine Release Syndrome (CRS), neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), prolonged cytopenia, and secondary hematological malignancies. Patients treated with Abecma have experienced severe reactions, including fatal outcomes in some cases. Due to these risks, Abecma is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Abecma's adverse reactions commonly include fever, CRS, hypogammaglobulinemia, infections, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea, and viral infections. Patients are monitored for various severe conditions post-infusion, and appropriate treatments are administered as needed.

The development and commercialization of Abecma in the U.S. are managed through a Co-Development, Co-Promotion, and Profit Share Agreement between 2seventy bio and BMS, with BMS responsible for activities outside the U.S. The ongoing and planned clinical studies (KarMMa-2, KarMMa-3) aim to explore Abecma's efficacy in earlier lines of treatment for multiple myeloma.

2seventy bio, with a mission to maximize the time patients can spend with their loved ones, emphasizes rapid translation of scientific discoveries into practical applications. This approach is reflected in their development of the first FDA-approved CAR T cell therapy for multiple myeloma. The company remains dedicated to its mission, ensuring that its operations and culture align with its core values.

(Note: The original document's Forward-Looking Statement section has been excluded from this summary.)