Opdivo (nivolumab) plus Yervoy (ipilimumab) demonstrates statistically significant and clinically meaningful improvement in progression-free survival compared to investigator’s choice of chemotherapy

Combination of Opdivo plus Yervoy is the only dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR metastatic colorectal cancer

Bristol Myers Squibb announced the Phase 3 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.

“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.”

CheckMate -8HW is a Phase 3 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.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.