2Seventy Bio has decided to halt enrollment in the Phase 3 KarMMa-9 study evaluating Abecma (idecabtagene vicleucel) in newly diagnosed multiple myeloma patients who have less than optimal responses to stem cell transplants. The decision, announced Wednesday, was driven by financial considerations and the rapidly evolving treatment landscape in multiple myeloma.
Financial Strategy and Shifting Priorities
The decision to discontinue enrollment in the KarMMa-9 trial is expected to save 2Seventy Bio approximately $80 million in the near term. This move is part of a broader strategy to achieve financial breakeven in the coming year. The company reported a $27 million loss from operations in the second quarter and held approximately $200 million in cash, cash equivalents, and marketable securities as of June 30.
Impact of Evolving Treatment Landscape
2Seventy Bio and Bristol Myers Squibb, which co-developed Abecma, acknowledged that the decision to halt the trial was influenced by the "greatly improved" treatment landscape for newly diagnosed multiple myeloma patients. Anna Truppel-Hartmann, 2Seventy’s chief medical officer, noted that this evolving landscape has resulted in "considerably fewer" patients who are eligible for a study like KarMMa-9.
Abecma's Current Market Position
Abecma was initially approved in 2021 for a narrower group of patients and later expanded in spring 2024 for use in hard-to-treat multiple myeloma cases that aren’t adequately controlled after two or more prior lines of therapy. While the KarMMa-9 trial aimed to explore Abecma's potential in earlier lines of treatment, the company believes the drug continues to show "encouraging signs of growth" in its currently approved indications. U.S. revenue from Abecma totaled $54 million between April and June, and 2Seventy Bio anticipates that number rising around 30% in the third quarter. The company also anticipates patient demand for the drug to increase by double-digits compared to the second quarter.
Competitive Context
The multiple myeloma treatment market has become increasingly competitive. Johnson & Johnson and Legend Biotech's Carvykti gained approval as a second-line treatment for adults with relapsed or refractory multiple myeloma in April. Gilead Sciences and Arcellx are also advancing anito-cel, a newer medicine, with a late-stage study initiated last month and data expected by 2028. This study is assessing anito-cel in participants who’ve already received between one and three types of treatments for their multiple myeloma.
2Seventy Bio's Strategic Realignment
Wednesday’s announcement follows other moves 2Seventy Bio has made this year to tailor the business and hasten it toward profitability. In January, the company sold its pipeline of cell therapy research to Regeneron for $5 million. Then in June, it handed off a hemophilia A research program to Novo Nordisk in exchange for $38 million. Shares of 2Seventy were down 8% Wednesday, hovering around $4.40 apiece. The biotech’s stock has lost more than 80% of its value since it began trading on the Nasdaq in late 2021.
