Hepatocellular carcinoma (HCC), the most common form of primary liver cancer, has seen a significant development with the recent validation of Bristol Myers Squibb’s application by the European Medicines Agency (EMA) for the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or advanced HCC who have not received prior systemic therapy. This application validation stems from the Phase 3 CheckMate -9DW trial, marking the commencement of the EMA’s centralized review process.
The announcement underscores the pressing need for improved therapeutic options for HCC, which remains a challenging cancer to treat, particularly in its advanced stages. The prognosis for patients with advanced HCC is often poor despite recent advancements, highlighting the urgency for treatments that can provide better clinical outcomes. According to Dana Walker, M.D., M.S.C.E., vice president at Bristol Myers Squibb, around 62,000 liver cancer cases are diagnosed annually in the European Union, with HCC being predominant. She emphasizes the potential of Opdivo plus Yervoy to offer a new dual immunotherapy combination for this patient population.
Hepatocellular Carcinoma: Opdivo and Yervoy Show Improved Survival in Phase 3 CheckMate -9DW Trial
The Phase 3 CheckMate -9DW trial demonstrated that the combination of Opdivo plus Yervoy significantly improved overall survival (OS) compared to the investigator’s choice of lenvatinib or sorafenib, thus showing a clear clinical benefit when used as a first-line treatment. The safety profile of the combination therapy remained consistent with previous reports and was manageable with established protocols, with no new safety concerns identified. These findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, further validating the potential of this therapeutic approach.
The CheckMate -9DW trial is a randomized, open-label study that enrolled approximately 668 patients. Participants were randomized to receive either the combination of Opdivo and Yervoy or lenvatinib or sorafenib monotherapy. The trial’s primary endpoint was overall survival, with secondary endpoints including objective response rate and time to symptom deterioration. The promising results from this trial have paved the way for Bristol Myers Squibb to advance their application, working closely with the EMA to bring this new treatment option to patients in need.
Hepatocellular Carcinoma: A Global Health Crisis with Limited Treatment Options
Hepatocellular carcinoma is a major global health concern, being the third leading cause of cancer-related deaths worldwide. It accounts for 75% to 85% of all liver cancers, with most cases being diagnosed at an advanced stage. Effective treatment options are limited, often resulting in poor outcomes. Recurrence rates for HCC are high, with up to 70% of patients experiencing recurrence within five years, especially those at high risk after surgery or ablation. While hepatitis B and C infections are the primary causes, the rising prevalence of metabolic syndrome and nonalcoholic steatohepatitis (NASH) is expected to further increase HCC rates.
Bristol Myers Squibb is dedicated to transforming the lives of patients through innovative cancer treatments. Their commitment to oncology research aims to develop medicines that not only extend survival but also improve the quality of life for patients. By leveraging advanced scientific research and digital technologies, Bristol Myers Squibb is at the forefront of personalized medicine, seeking to offer tailored treatment solutions for various cancers. Their ongoing efforts in understanding cancer biology and developing new therapeutic strategies demonstrate their resolve in tackling cancer from all possible angles.
In conclusion, the validation of the application for Opdivo plus Yervoy by the EMA marks a significant step forward in the treatment of unresectable or advanced hepatocellular carcinoma. Bristol Myers Squibb’s dedication to enhancing cancer care continues to provide hope for better clinical outcomes and improved quality of life for patients battling this challenging disease.
Resource: Business Wire , July 19, 2024
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