Bristol Myers Squibb’s immunotherapy combination therapy, Opdivo plus Yervoy, has received validation from the European Medicines Agency (EMA) for its application as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC) in adults who have not received prior systemic therapy.
The application is supported by positive results from the Phase 3 CheckMate -9DW trial, which demonstrated improved overall survival with Opdivo and Yervoy compared to lenvatinib or sorafenib alone. The validation of the application marks the start of the EMA’s centralized procedure review to evaluate the potential of this combination therapy for HCC patients.
With an estimated 62,000 HCC cases diagnosed annually in the European Union, its prevalence highlights the need for effective treatments in advanced stages. The promising results of the CheckMate -9DW trial suggest that Opdivo plus Yervoy has the potential to provide a new treatment option with improved clinical outcomes.
The combination of Opdivo and Yervoy exhibited a manageable safety profile consistent with previous data without any new safety concerns identified. The positive results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Bristol Myers Squibb acknowledges the contributions of patients and investigators involved in the CheckMate -9DW clinical trial, which evaluated the effectiveness of Opdivo plus Yervoy compared to lenvatinib or sorafenib in untreated HCC patients. The combination therapy aims to improve survival outcomes and reduce symptom deterioration, offering hope to patients with this aggressive cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
