Officials with the FDA have approved nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).1
Researchers evaluated this regimen’s efficacy in the CheckMate 9DW (NCT04039607) clinical trial, which was an open-label trial in which 668 adults with unresectable or metastatic HCC were randomly assigned to receive either nivolumab 1 mg/kg as an intravenous (IV) infusion with ipilimumab 3 mg/kg intravenously every 3 weeks for a maximum of 4 doses, followed by single-agent nivolumab 480 mg intravenously every 4 weeks, or investigator’s choice of lenvatinib or sorafenib.
Researchers noted that the median overall survival was 23.7 months (95% confidence interval [CI], 18.8-29.4) in the nivolumab + ipilimumab arm and 20.6 months (95% CI, 17.5-22.5) in the lenvatinib or sorafenib arm (hazard ratio, 0.79 [95% CI, 0.65-0.96]; P<.0180. The overall response rate was 36.1% (95% CI, 31.0-41.5) and 13.2% (95% CI, 9.8-17.3) in the respective arms (P<.0001).
The most common adverse reactions were rash, pruritus, fatigue, and diarrhea.
Reference
- FDA. FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma [press release]. April 11, 2025. Accessed April 30, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma