FDA approves Opdivo for treatment of hepatocellular carcinoma
Opdivo is already indicated to treat various renal, urothelial, head and neck carcinomas as well as classical Hodgkin lymphoma, melanoma, and non-small cell lung cancer.
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This accelerated approval is based on tumor response rate and durability of response data from the CheckMate -040 trial; continued approval may be based on verification and description of clinical benefit in confirmatory trials.
The Phase 1/2, open-label, multicenter study (n=154) evaluated treatment with Opdivo in patients with HCC who progressed on or were intolerant to sorafenib. Efficacy outcomes included confirmed overall response rate and duration of response. All patients had previously received treatment with sorafenib and 19% had received ≥2 systemic therapies.
The data showed 14.3% (95% CI: 9.2–20.8) of patients responded to Opdivo treatment of which 1.9% showed complete response and 12.3% showed partial response. Of the total responders (n=22), their responses ranged from 3.2–38.2+ months. Most patients (91%) had responses lasting ≥6 months and about half of the patients (55%) had responses lasting ≥12 months. The overall response rate based on modified RECIST was 18.2% with complete response rate of 3.2% and partial response rate of 14.9%. These responses were seen across all PD-L1 expression levels.
Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated to treat various renal, urothelial, head and neck carcinomas; classical Hodgkin lymphoma, melanoma, and non-small cell lung cancer.
Bristol-Myers Squibb's Opdivo® (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with Sorafenib [press release]. Bristol-Myers Squibb. September 22, 2017. https://investors.bms.com/iframes/press-releases/press-release-details/2017/Bristol-Myers-Squibbs-Opdivo-nivolumab-Receives-FDA-Approval-for-the-Treatment-of-Hepatocellular-Carcinoma-Patients-Previously-Treated-with-Sorafenib/default.aspx