The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This positive opinion follows the successful results from the CheckMate -8HW trial, which demonstrated a significant reduction in the risk of disease progression or death for patients treated with the combination therapy.
CheckMate -8HW Trial Results
The positive opinion from the CHMP is based on the results from the CheckMate -8HW trial, which showed a 79% reduction in the risk of disease progression or death in the patient population treated with Opdivo/Yervoy compared to chemotherapy. The trial’s findings, with a hazard ratio (HR) of 0.21 and a 95% confidence interval (CI) of 0.14-0.32, were statistically significant (p<0.0001), supporting the use of the combination therapy as a first-line treatment option.
Global Approval Status
Notably, Opdivo/Yervoy previously received marketing approval as a first-line treatment for MSI-H/dMMR CRC in China in October 2024, marking the combination’s first global approval. This latest recommendation from the CHMP in Europe further expands the potential patient population that could benefit from this immunotherapy combination, offering a new treatment option for those with MSI-H/dMMR mCRC.-Fineline Info & Tech
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