FDA Approves Combo of Opdivo Plus Yervoy for Advanced Liver Cancer

TUESDAY, April 15, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC).

The CheckMate-9DW combination of Opdivo plus Yervoy was previously granted accelerated approval by the FDA in 2020 and has been an established second-line treatment for patients with advanced HCC who were previously treated with sorafenib, but this FDA decision converts the existing indication to full approval and expands the indication into the first-line setting.

The approval is based on the results from the CheckMate-9DW trial, in which 85 percent of patients in the comparator arm were treated with lenvatinib and 15 percent were treated with sorafenib monotherapy. For the 335 participants treated with Opdivo plus Yervoy, median overall survival was 23.7 months compared with 20.6 months with lenvatinib or sorafenib (hazard ratio, 0.79). At three years, Opdivo plus Yervoy led to an overall survival rate of 38 percent compared with 24 percent with lenvatinib or sorafenib monotherapy. Opdivo plus Yervoy also led to an overall response rate of 36.1 percent compared with 13.2 percent for patients treated with lenvatinib or sorafenib (complete response, 6.9 versus 1.8 percent; partial response, 29.3 versus 11.4 percent). Additionally, the combination treatment was associated with longer responses, with a median duration of response of 30.4 months. This compared with 12.9 months for lenvatinib or sorafenib. No new safety signals were identified.

“The CheckMate-9DW approval is an important advancement for patients, considering the incidence of liver cancer has tripled in the last four decades, yet prognosis for HCC patients remains poor,” Aiwu Ruth He, M.D., Ph.D., a CheckMate-9DW study investigator from MedStar Georgetown University Hospital in Washington, D.C., said in a statement. “Given the strength of evidence from the trial, especially considering the selection and performance of a strong comparator arm, I believe that Opdivo plus Yervoy has the potential to become a standard of care for the first-line treatment of patients with unresectable or metastatic HCC.”

Full approval of Opdivo plus Yervoy was granted to Bristol Myers Squibb.

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