The following is a summary of “Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial,” published in the March 2023 issue of Oncology by Yau, et al.

For a study, researchers sought to evaluate the safety and efficacy of nivolumab plus cabozantinib, with or without ipilimumab, in patients with advanced hepatocellular carcinoma who were treatment-naive, sorafenib-intolerant, or had progressed on sorafenib.

In cohort 6 of the CheckMate 040 study, 71 patients were randomly assigned to receive nivolumab 240 mg every 2 weeks plus cabozantinib 40 mg once daily (doublet arm) or nivolumab 3 mg/kg every 2 weeks plus cabozantinib 40 mg once daily with ipilimumab 1 mg/kg once every 6 weeks (triplet arm). The primary objectives were to evaluate the safety and tolerability, objective response rate, and duration of response by investigator assessment per RECIST v1.1. Secondary objectives included progression-free survival and overall survival.

After a median follow-up of 32.0 months, the objective response rate (95% CI) was 17% (6 to 33) in the doublet arm and 29% (15 to 46) in the triplet arm. The median duration of response was 8.3 months (6.9 to not estimable) in the doublet arm and not reached in the triplet arm. The median progression-free survival was 5.1 months in the doublet arm and 4.3 months in the triplet arm. The median overall survival was 20.2 months in the doublet arm and 22.1 months in the triplet arm. Grade 3-4 treatment-related adverse events occurred in 50% and 74% of doublet and triplet arms patients, respectively. Treatment-related adverse events leading to discontinuation were reported for 11% and 23% of doublet and triplet arms patients, respectively. No treatment-related deaths occurred in either arm.

The study concluded that nivolumab plus cabozantinib, with or without ipilimumab, showed promising antitumor activity and had a safety profile consistent with the individual drugs in patients with advanced hepatocellular carcinoma who were treatment-naive, sorafenib-intolerant, or had progressed on sorafenib.

Reference: ascopubs.org/doi/full/10.1200/JCO.22.00972