A Milestone in Colorectal Cancer Treatment: Opdivo and Yervoy Show Remarkable Efficacy

In a landmark development in the Phase 3 CheckMate -8HW trial, the combination of immunotherapies, Opdivo and Yervoy, significantly reduced disease progression or death by 79% in MSI-H/dMMR metastatic colorectal cancer compared to chemotherapy. This breakthrough marks the first time a dual immunotherapy has shown such efficacy with fewer side effects, offering new hope for patients.

Bristol Myers Squibb announced results from the Phase 3 CheckMate -8HW trial, evaluating the efficacy of a dual immunotherapy regimen in treating metastatic colorectal cancer. The study, which examined the combination of Opdivo (nivolumab) and Yervoy (ipilimumab), revealed a significant reduction in the risk of disease progression or death by 79% when compared to traditional chemotherapy methods. The trial's findings, set to be presented at the 2024 ASCO Gastrointestinal Cancers Symposium, mark a pivotal moment in cancer treatment, highlighting the potential of immunotherapy as a first-line treatment option.

“With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer. Today, with these data from CheckMate -8HW, we showed that Opdivo plus Yervoy reduced the risk of disease progression or death by an unprecedented 79%,” said Dr. Dana Walker, Vice president, Global Program Lead, Bristol Myers Squibb.

The safety profile of Opdivo and Yervoy

The combination of Opdivo and Yervoy maintained a consistent and manageable safety profile, aligning with prior data, without new safety concerns. Treatment-related adverse events (TRAEs) of Grade 3/4 were lower in the Opdivo plus Yervoy group (23%) compared to the chemotherapy group (48%). Discontinuations due to TRAEs were also lower with the combination therapy (17%) versus chemotherapy (32%).

Implications for Colorectal Cancer Treatment

This study is a beacon of hope for patients with MSI-H/dMMR mCRC. Dr. Thierry Andre, Head of the Medical Oncology Department, Sorbonne University, emphasized the "impressive improvement in PFS and sustained benefit" observed in the trial. “These results demonstrate the meaningful efficacy of this combination with practice-changing potential for this patient population.”

Key Findings of the CheckMate -8HW Trial

The CheckMate -8HW trial, involving approximately 830 patients, compared the efficacy of Opdivo plus Yervoy against the investigator’s choice of chemotherapy. The results were staggering:

• A 79% reduction in the risk of disease progression or death (Hazard Ratio [HR]: 0.21) in patients treated with Opdivo plus Yervoy.
• Progression-free survival (PFS) was markedly improved with the immunotherapy combination, with median PFS not yet reached, versus 5.9 months for chemotherapy.
• Consistent PFS benefits were observed across various subgroups, including patients with different types of mutations and metastases.
• The safety profile of Opdivo plus Yervoy remained manageable, with fewer severe treatment-related adverse events compared to chemotherapy.

This breakthrough is especially significant for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC), a group historically less responsive to conventional chemotherapy.

The CheckMate -8HW trial is ongoing, with the aim to further assess the efficacy of Opdivo plus Yervoy compared to Opdivo alone and other secondary endpoints, including overall survival (OS). The trial’s groundbreaking findings are a testament to the strides being made in cancer research, particularly in the realm of immunotherapy.