The FDA-approved combination of Opdivo plus Yervoy is rapidly reshaping first-line treatment for advanced hepatocellular carcinoma (HCC). The April 2025 approval was based on results from the phase 3 CheckMate 9DW trial, which compared the immunotherapy combination against standard tyrosine kinase inhibitors, including Lenvima and Nexavar.
The study showed the immunotherapy regimen improved median overall survival to 23.7 months compared with 20.6 months for TKIs. Long-term outcomes were also stronger, with nearly one-third of patients receiving immunotherapy still alive at four years. Response rates were significantly higher as well, reaching 36% versus 13% with TKIs, while responses lasted far longer.
Doctors emphasized that the regimen requires a precise dosing schedule and is best suited for patients with preserved liver function. Although the treatment carries a higher risk of immune-related side effects and treatment discontinuation, some patients who stopped therapy due to toxicity still experienced extended survival benefits.
Experts noted that real-world adoption is growing, especially among oncologists already familiar with the regimen from lung, kidney, and melanoma treatment. However, insurance barriers and prior authorization requirements continue to slow broader access in some regions.