The FDA has accepted the supplemental biologics license application and granted breakthrough therapy designation to nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib (Nexavar).
The agency based its decision on data from the nivolumab-ipilimumab cohort of the ongoing, open-label, multi-cohort phase I/II CheckMate -040 study – designed to evaluate the dual immune-oncology therapy in in patients with advanced HCC previously treated with sorafenib. Data from the study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in June.
In the nivolumab-ipilimumab cohort, researchers are evaluating the safety and efficacy of the combination in patients with previously treated advanced HCC. Safety and tolerability, as well as objective response rate based on investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) are the primary endpoints of the study. Secondary endpoints include disease control rate, duration of response, overall survival, time to response, time to progression and progression-free survival.
“The FDA’s acceptance of our application for Opdivo plus Yervoy represents important progress for patients with liver cancer in the United States, where hepatocellular carcinoma is the fastest rising cause of cancer-related death,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb – the manufacturer of nivolumab – said in a press release.
“Despite recent advances, hepatocellular carcinoma remains a difficult-to-treat cancer and patients are in need of additional effective treatment options,” he added. “We look forward to working with the FDA to bring the potential of a dual immuno-oncology therapy to these patients for the first time.”
Under the priority review, the agency set a Prescription Drug User Fee Act (PDUFA) date of March 10, 2020.
Bristol-Myers Squibb. U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma. Available from: https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-0. Accessed: November 11, 2019.
November 11, 2019