EMA Validates Bristol Myers Squibb’s Opdivo and Yervoy for First-Line Treatment

28 June 2024

The European Medicines Agency (EMA) has officially validated Bristol Myers Squibb’s application for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment in adult patients with metastatic colorectal cancer characterized by high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). This validation signifies that the submission is complete, initiating the EMA's centralized review process.

Colorectal cancer ranks as the third most common cancer globally, necessitating more treatment options, especially for MSI-H/dMMR metastatic colorectal cancer (mCRC) patients who typically do not respond well to chemotherapy. Dana Walker, M.D., M.S.C.E., vice president and global program lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb, emphasized the company's eagerness to collaborate with the EMA to bring this dual immunotherapy option to European patients.

The application is grounded on findings from the CheckMate -8HW study. This study demonstrated that the combination of Opdivo and Yervoy significantly improved progression-free survival (PFS) when compared to the investigator's choice of chemotherapy, as assessed by Blinded Independent Central Review (BICR). These results were presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. The study continues to evaluate other primary and secondary endpoints, including PFS when comparing Opdivo plus Yervoy to Opdivo alone. The safety profile of the Opdivo and Yervoy combination was consistent with previously reported data and manageable using established protocols, with no new safety concerns identified.

The CheckMate -8HW trial, a Phase 3 randomized, open-label study, involves approximately 830 patients with MSI-H or dMMR mCRC. Participants were randomized to receive either Opdivo alone, Opdivo combined with Yervoy, or chemotherapy of the investigator's choice. The trial's dual primary endpoints are the PFS rate of Opdivo plus Yervoy compared to chemotherapy and the PFS rate of the combination therapy compared to Opdivo alone. Secondary endpoints also include overall survival and other safety and efficacy measures. The study is ongoing to further assess these outcomes.

Mismatch repair deficiency (dMMR) refers to the lack of functional proteins that repair errors in DNA replication, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic colorectal cancer patients fall into this category, which is associated with a poor response to chemotherapy and a generally poor prognosis.

Bristol Myers Squibb aims to transform patients' lives through scientific advancements, particularly in cancer care. Their research focus is on delivering treatments that offer better, longer, and potentially curative outcomes for patients. By exploring new frontiers in personalized medicine and leveraging innovative digital platforms, Bristol Myers Squibb is committed to understanding and addressing cancer from multiple angles.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that helps restore the body's anti-tumor immune response, making it a crucial treatment for multiple cancer types. The Opdivo development program has treated over 35,000 patients globally and contributed to a deeper understanding of biomarkers in patient care. Since its first regulatory approval in July 2014, Opdivo has been approved in over 65 countries. The combination of Opdivo and Yervoy was the first immuno-oncology regimen to receive regulatory approval for metastatic melanoma in October 2015 and is now approved in more than 50 countries.

Yervoy is a monoclonal antibody that inhibits the CTLA-4 protein, enhancing T-cell activity against tumors. Since its FDA approval in March 2011 for metastatic melanoma, Yervoy has been approved in over 50 countries and is under ongoing development for multiple tumor types.

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