Phase III CheckMate -8HW trial evaluating Opdivo (nivolumab) + Yervoy (ipilimumab) compared to chemotherapy in microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer meets primary endpoint
Bristol Myers Squibb announced the Phase III CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) met the dual primary endpoint of progression-free survival (PFS)
as assessed by Blinded Independent Central Review (BICR) at a pre-specified interim analysis.
The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.
CheckMate -8HW is a Phase III randomized, open-label trial evaluating Opdivo plus Yervoy compared to either Opdivo alone or investigator’s choice of chemotherapy in patients with MSI-H or dMMR mCRC. The dual primary endpoints of the trial are PFS per BICR for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints. The company will complete a full evaluation of the available CheckMate -8HW data and work with investigators to share the results with the scientific community at an upcoming medical conference, as well as discuss with health authorities.
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