Bristol Myers says Phase 3 RELATIVITY-123 trial to be discontinued

Bristol Myers Squibb announced that the Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns. The safety profile was consistent with previously reported studies of the fixed-dose combination of nivolumab and relatlimab. Investigation of the fixed-dose combination of nivolumab and relatlimab as a treatment for other tumor types will continue as planned. These results do not impact the currently approved indication for patients with unresectable or metastatic melanoma. “Metastatic colorectal cancer is a challenging cancer to treat with high unmet needs. Though there have been advances in treating patients with microsatellite instability-high/deficient mismatch repair colorectal cancers, patients with microsatellite stable tumors continue to have limited treatment options in later lines of therapy. While we know immunotherapies have historically demonstrated limited efficacy in MSS colorectal cancers, we had hoped to demonstrate meaningful clinical benefit in this patient population and are disappointed in this outcome,” said Jeffrey Walch, M.D., Ph.D., vice president, global program lead, Bristol Myers Squibb. “We continue to be committed to the development of I-O therapies, including Opdivo and Yervoy, in MSI-H/dMMR colorectal cancers, and we thank the investigators, patients, and their loved ones who participated in this trial.” The company will share the data with investigators so they may determine appropriate next steps for patients enrolled in the RELATIVITY-123 trial. The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community.