Bristol Myers Squibb (NYSE:BMY) has encountered a setback with its decision to terminate the late-stage RELATIVITY-123 study, posing challenges in the realm of advanced colorectal cancer treatments. The phase III trial, exploring the Opdivo (nivolumab) and relatlimab combination, was discontinued based on the outcome of an independent data monitoring committee’s planned analysis, revealing that it was unlikely to meet primary endpoints upon completion.
Despite the disappointment, Bristol Myers clarified that the study’s termination was not prompted by safety concerns. The safety profile remained consistent with prior studies of the Opdivo and relatlimab combination. While advanced treatments exist for patients with specific colorectal cancers, those with microsatellite stable (“MSS”) tumors face limited options in later therapy lines.
The company, undeterred by this setback, continues to assess the Opdivo and relatlimab combination for other tumor types as originally planned. The combination, marketed as Odualag, is already approved for unresectable or metastatic melanoma treatment in the United States.
The discontinuation of RELATIVITY-123 will not impact the existing approval for Odualag. Relatlimab, a lymphocyte-activation gene 3-blocking antibody, is concurrently undergoing evaluation in clinical trials in combination with other agents across various tumor types.
Despite challenges in the colorectal cancer study, Bristol Myers pursues diversification strategies to counteract the slowing growth of flagship drugs like Revlimid and Eliquis, now facing generic competition. The company faces additional setbacks, including the FDA’s delay in deciding on the supplemental Biologics License Application for Abecma, a drug co-developed with partner 2seventy Bio, Inc.
The FDA’s Oncologic Drugs Advisory Committee will review data supporting Abecma’s application, though the meeting date is yet to be confirmed. Bristol Myers Squibb and 2seventy bio aim to reinforce the drug’s potential to deliver improved outcomes for patients with triple-class exposed relapsed or refractory multiple myeloma.
Recent portfolio expansions, such as the FDA approval for repotrectinib targeting ROS1 oncogenic fusions, under the brand name Augtyro, highlight Bristol Myers’ commitment to strengthening its product offerings. However, the company faces the ongoing challenge of compensating for declining revenues from Revlimid and Eliquis.
While Opdivo maintains momentum and new drugs like Opdulag show promise, the loss of Revlimid revenues continues to exert pressure on Bristol Myers’ overall financial performance. Shares of BMY have experienced a 29.1% decline year to date, compared to the industry’s decrease of 17.6%.
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