Bristol Myers Squibb announced the discontinuation of the Phase 3 RELATIVITY-123 trial, which was evaluating the fixed-dose combination of nivolumab and relatlimab as a treatment for microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients. This decision comes after an independent data monitoring committee determined that the trial was unlikely to meet its primary endpoints of overall survival.

The discontinuation was not due to safety concerns but rather the futility of the trial’s outcomes. The safety profile of the combination treatment was consistent with findings from previous studies. Despite this setback, Bristol Myers Squibb remains committed to developing immunotherapy options and will continue investigating nivolumab and relatlimab for other tumor types. The results won’t affect the existing approval for melanoma patients.

Jeffrey Walch, M.D., Ph.D., Vice President at Bristol Myers Squibb, expressed disappointment in the trial’s findings, acknowledging the high unmet need for effective treatments in MSS mCRC, where immunotherapies have historically shown limited efficacy. The company extends gratitude to the trial’s investigators, patients, and families and plans to share the data from the RELATIVITY-123 trial to inform the next steps and future research.

RELATIVITY-123 was designed to compare the efficacy of the fixed-dose combination of nivolumab and relatlimab to regorafenib or trifluridine plus tipiracil (TAS-102) in patients with MSS mCRC who had progressed despite prior therapies. The dual primary endpoints were overall survival and progression-free survival in patients with a PD-L1 combined positive score (CPS) ≥ 1. Secondary endpoints included objective response rate, duration of response, safety, and effects on physical function and quality of life. The trial did not include patients with MSI-H or dMMR tumors.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.