Bristol Myers Squibb has secured approval for the combination of Opdivo (nivolumab) 1 mg/kg and Yervoy (ipilimumab) 3 mg/kg from the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC) in patients who were previously treated with sorafenib.
Approval for the indication has been issued under accelerated approval on the basis of overall response rate and duration of response noted in the Opdivo + Yervoy cohort of the phase 1/2 CheckMate -040 trial.
According to Bristol Myers Squibb, continued approval for the indication in hepatocellular carcinoma could depend upon verification and description of clinical benefit in confirmatory clinical trials.
In the CheckMate -040 cohort of 49 hepatocellular carcinoma patients treated previously with sorafenib, following a minimum follow up of 28 months, 33% of them responded to the Opdivo + Yervoy treatment. Bristol Myers Squibb said that 8% showed complete response (CR), while 24% had a partial response (PR).
Duration of responses (DOR) varied from 4.6 to 30.5+ months, with 88% lasting more than six months, 56% at least 12 months and 31% for more than 24 months.
The Opdivo + Yervoy combination is the only dual immunotherapy to get FDA approval in this setting, said Bristol Myers Squibb. The US pharma company said that the combination therapy has a potentially synergistic mechanism of action that targets two different checkpoints PD-1 and CTLA-4 and works in complementary ways.
The combination was previously given breakthrough therapy designation for the indication and also a priority review from the FDA. It is now approved for the treatment of four forms of cancer.
Adam Lenkowsky – general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb said: “We recognize there is a critical need to provide patients with aggressive forms of cancer, like HCC, new treatment options that may offer clinically meaningful and ultimately durable responses.
“Today’s announcement builds on our legacy in pioneering immunotherapy treatments and is an important step in our commitment to transforming patients’ lives through science.”