FDA accepts Opdivo + Yervoy combination for patients with previously treated advanced hepatocellular carcinoma (liver cancer). - BMS

Bristol-Myers Squibb Company announced that the FDA has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib.

The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020.

This application is based on data from the Opdivo plus Yervoy cohort of the Phase 1/II CheckMate -040 study evaluating the Immuno-Oncology combination in patients with advanced HCC previously treated with sorafenib. Data from this study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

CheckMate -040 (NCT01658878) is an ongoing Phase 1/II, open-label, multi-cohort study investigating Opdivo or Opdivo-based combinations in patients with advanced HCC with and without chronic viral hepatitis who are na�ve, intolerant to or who have progressed during sorafenib therapy. The Opdivo plus Yervoy cohort of CheckMate -040 is evaluating the safety and efficacy of the combination in patients with previously treated advanced HCC. Primary endpoints include safety and tolerability, and objective response rate based on investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints include disease control rate, duration of response, overall survival, time to response, time to progression and progression-free survival.