Bristol Myers Squibb (BMS) recently submitted an application to the European Medicines Agency (EMA) for the use of the immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with MSI-H or dMMR metastatic colorectal cancer (mCRC).

The EMA’s acceptance of this application initiates the centralized review process. The application is primarily based on data from the CheckMate -8HW study, which demonstrated statistically significant improvements in progression-free survival (PFS) when Opdivo plus Yervoy was used compared to chemotherapy.

MSI-H or dMMR mCRC patients typically do not respond well to chemotherapy, so the outcome of the CheckMate -8HW study highlights the potential of the Opdivo and Yervoy combination to offer a much-needed treatment option for these patients.

The safety profile of the immunotherapy combination was consistent with previous studies and manageable with established protocols. No new safety concerns were identified.

BMS acknowledges the contributions of patients and investigators involved in the CheckMate -8HW clinical trial. The study is still ongoing to evaluate the long-term effectiveness of Opdivo plus Yervoy in this patient population.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.