Bristol-Myers Squibb announced the U.S. FDA has granted accelerated approval to Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Accelerated approval was based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate -040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In the CheckMate -040 cohort of HCC patients previously treated with sorafenib, after a minimum follow up of 28 months, 33% of patients responded to treatment with Opdivo + Yervoy; 8% (4/49) had a complete response (CR) and 24% (12/49) had a partial response (PR). Duration of responses (DOR) ranged from 4.6 to 30.5+ months, with 88% lasting at least six months, 56% at least 12 months and 31% at least 24 months. Overall response rate (ORR) and DOR were assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR assessed by BICR using modified RECIST was 35%, with a CR reported in 12% (6/49) of patients and a PR reported in 22% (11/49) of patients.
Opdivo + Yervoy was granted Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.
About Opdivo (nivolumab) and Yervoy (ipilimumab)
Opdivo (nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor. Yervoy (ipilimumab) targets CTLA-4, a protein receptor that regulates the immune system.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and is the most common cause of death in people with cirrhosis.