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BMS to Discuss First-Line Opdivo-Yervoy Colorectal Cancer Approval With Health Authorities

NEW YORK – Bristol Myers Squibb said on Thursday that it is planning to share with health authorities the results of the Phase III CheckMate-8HW trial of Opdivo plus Yervoy (nivolumab plus ipilimumab) in metastatic microsatellite instability (MSI)-high or DNA mismatch repair deficient (dMMR) colorectal cancer.

In the randomized trial, first-line treatment with BMS's immune checkpoint inhibitor combination met one of its primary endpoints, improved progression-free survival versus chemotherapy in MSI-high or dMMR colorectal cancer. The trial design included three arms: one with the immunotherapy combination, one with Opdivo alone, and one with investigator's choice of chemotherapy alone.

BMS is still waiting to evaluate the trial's other primary endpoint, progression-free survival with Opdivo-Yervoy compared to Opdivo alone in any treatment line. In the meantime, the drugmaker said it is working on a full evaluation of the available results data to share at an upcoming medical conference and is discussing the data with health authorities.

Based on results of the previous CheckMate-142 trial, Opdivo, either alone or combined with Yervoy, was already US Food and Drug Administration-approved in 2018 for metastatic MSI-high/dMMR colorectal cancer patients who have previously received chemotherapy. In 2021, the combination of the two was approved for the same second-line patient population in Europe.