Bristol Myers’ phase 3 trial for Opdivo+Yervoy in mCRC meets primary endpoints

Bristol Myers Squibb “announced the Phase 3 CheckMate -8HW trial evaluating Opdivo, or nivolumab, plus Yervoy or ipilimumab, compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, mCRC, met the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Reviewat 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. 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. “The benefits of Opdivo plus Yervoy in MSI-H/dMMR mCRC were established previously in CheckMate -142, in which the dual immunotherapy combination demonstrated strong and durable anti-tumor activity among patients who had progressed after prior fluoropyrimidine-based combination chemotherapy,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “Now, with these positive results from CheckMate -8HW, we have randomized data showing Opdivo plus Yervoy significantly improved PFS in the first line setting for patients with MSI-H/dMMR mCRC. These results further support the benefits of dual PD-1 and CTLA-4 inhibition, and demonstrate our continued commitment to pursue combination strategies that may help improve outcomes for patients with high unmet need.”