FDA granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo and Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Bristol-Myers Squibb Co. sponsors the drugs.
Efficacy of the combination was investigated in Cohort 4 of CHECKMATE-040, (NCT01658878) a multicenter, multiple cohort, open-label trial conducted in patients with HCC who progressed on or were intolerant to sorafenib. A total of 49 patients received nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg every 3 weeks for four doses, followed by single-agent nivolumab 240 mg every 2 weeks until disease progression or unacceptable toxicity.
The main efficacy outcome measures were overall response rate and duration of response as determined by blinded independent central review using RECIST v1.1. ORR was 33% (n=16; 95% CI: 20, 48), with 4 complete responses and 12 partial responses. Response duration ranged from 4.6 to 30.5+ months, with 31% of responses lasting at least 24 months.
