Bristol-Myers Squibb Company 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.

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. CheckMate -8HW is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator?s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability?high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

Approximately 830 patients were randomized to receive either Opdivo monotherapy (Opdivo 240 mg Q2W for six weeks, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four weeks, followed by Opdivo 480 mg Q4W), or investigator?s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival per blinded independent central review (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 trial also includes several secondary safety and efficacy endpoints, including overall survival.

The study is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints. Colorectal cancer is cancer that develops in the colon or the rectum, which are part of the body?s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world.

In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined. Mismatch repair deficiency occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors; they are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

Bristol Myers Squibb is inspired by a single vision ? transforming patients? lives through science.

The goal of the company?s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle.

Cancer can have a relentless grasp on many parts of a patient?s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.