https://ir.2seventybio.com/news-releases/...rmma-9-study-and-previews
"2seventy bio Provides Update on KarMMa-9 Study and Previews Anticipated Strong Third Quarter Revenue Performance
September 25, 2024 at 6:00 AM EDT
2seventy and Bristol Myers Squibb discontinue enrollment in Phase 3 KarMMa-9 study
Decision results in over $80 million in anticipated cost savings for 2seventy over the next several years and accelerates path to breakeven in 2025
Expanded 3L+ label drives re-acceleration in Abecma U.S. revenues with third quarter revenue expected to grow approximately 30% from second quarter revenue of $54 million
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 25, 2024-- 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.
“With a greatly improved NDMM treatment landscape and following our rigorous review of the business case for the KarMMa-9 study, we have decided to discontinue enrollment in this Phase 3 study,” said Chip Baird, chief executive officer, 2seventy bio. “Abecma continues to show encouraging signs of growth with an expanded label in the third line and a differentiated safety profile. 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. We will continue to look for ways to optimize our business for growth while remaining true to our mission of delivering more time for patients.”
2seventy and its partner, BMS, remain committed to and strongly believe in the value that Abecma brings to patients and the important role it plays in the multiple myeloma treatment paradigm. Abecma has a differentiated safety profile and a competitive efficacy profile, particularly when combined with effective bridging therapies. The partners plan to continue expanding the reach of Abecma to as many multiple myeloma patients as possible.
Anna Truppel-Hartmann, chief medical officer, 2seventy bio, added, “Since we initiated the Phase 3 KarMMa-9 study in NDMM based on the positive data generated in a similar patient population in the KarMMa-2 cohort 2c study, the NDMM treatment landscape has improved considerably with the increasing use of quadruplet therapy induction, incorporation of more aggressive consolidation therapies, and the ongoing optimization of maintenance therapy regimens. As a result, there are considerably fewer eligible patients than when the study was first designed. We celebrate this progress in treatment options for patients and will continue to focus on serving patients with a high unmet need who will benefit most from Abecma. We would like to extend our deepest gratitude to the patients, their families, and the investigators and study staff who participated in this trial.”
Commercial Progress and Guidance
2seventy is pleased to report continued positive momentum in Abecma’s expected return to growth in the earlier line setting following the FDA’s approval in April 2024. The Company expects third quarter Abecma U.S. revenue growth of approximately 30% from second quarter revenue of $54 million. Demand, as measured by new patients undergoing apheresis in the third quarter, is also expected to reflect double-digit growth when compared to the second quarter of 2024. The Company remains committed to driving the continued success of Abecma in 2024 and beyond.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S." |
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