FDA Approves Opdivo Plus Yervoy for Advanced HCC

The Food and Drug Administration (FDA) has approved the combination use of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the agency has announced.

The FDA approved Opdivo wplus Yervoy for the first-line treatment of adults with unresectable or metastatic HCC.

The effectiveness of the regimen was determined in the CHECKMATE-9DW trial of 668 adults with unresectable or metastatic HCC. Patients were randomized to receive either 1 milligram per kilogram of Opdivo as an intravenous infusion with 3 milligrams per kilogram of Yervoy intravenously every three weeks for a maximum of four doses, followed by single-agent Opdivo at 480 milligrams intravenously every four weeks, or investigator’s choice of Lenvima (lenvatinib) or Nexavar (sorafenib) monotherapy.

The median overall survival was 23.7 months in the Opdivo plus Yervoy arm and 20.6 months in the investigator’s choice arm, while the objective response rates were 36.1% and 13.2%, respectively. The complete and partial response rates in the immunotherapy arm were 7% and 29%, respectively, compared with 2% and 11% in the control group.

In addition, the median duration of response was 30.4 months with the combination compared with 12.9 months with the monotherapy choices. The median progression-free (PFS) survival in these respective arms was 9.1 months versus 9.2 months. In the investigational arm, the 18- and 24-month PFS rates were 34% and 28% compared with 18% and 12%, respectively, in the control arm.

The most common side effects experienced by more than 20% of patients were rash, pruritis, fatigue and diarrhea.

This full approval builds upon the March 2020 accelerated FDA approval that was granted to Opdivo plus Yerboy for the treatment of patients with HCC who had received prior sorafenib, based on data from the phase 1/2 CheckMate 040 trial.

The recommended dosing is is 1 milligram per kilogram of Opdivo with 3 milligrams per kilogram of Yervoy intravenously every three weeks for a maximum of four doses, followed by 240 milligrams of Opdivo intravenously every two weeks or 480 milligrams of Opdivo intravenously as a single agent every four weeks.

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