Is OPDIVO Effective for Liver Cancer?

On December 13, 2021, Thomas Yau and colleagues from the University of Hong Kong published the effectiveness and safety results of the CheckMate 459 Phase III clinical trial in the medical journal "The Lancet Oncology." The trial focused on the use of the anti-PD-1 antibody drug OPDIVO (nivolumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC).

CheckMate 459 was a randomized, open-label, Phase III clinical trial that randomized 743 patients with advanced HCC in a 1:1 ratio into the OPDIVO group (240mg every two weeks, N=371) and the sorafenib group (400mg twice daily, N=372). Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS).

The trial was initiated following the confirmation of the efficacy and safety of OPDIVO for advanced HCC in the CheckMate 040 Phase I/II trial. This trial sought to compare and validate its efficacy against sorafenib.

With a median follow-up of 15.2 months for the OPDIVO group and 13.4 months for the sorafenib group, the median overall survival was 16.4 months for the OPDIVO group and 14.7 months for the sorafenib group. OPDIVO was associated with a 15% reduction in the risk of death.

Regarding safety, the most common Grade 3 or higher side effects were hand-foot syndrome (OPDIVO group <1%, N=1; sorafenib group 14%, N=52), increased AST (OPDIVO group 6%, N=22; sorafenib group 4%, N=13), and hypertension (OPDIVO group 0%; sorafenib group 7%, N=26). The incidence of serious side effects was 12% in the OPDIVO group (N=43) and 11% in the sorafenib group (N=39). The number of deaths related to treatment-related side effects was 4 in the OPDIVO group and 1 in the sorafenib group.

Based on the results of the CheckMate 459 trial, Thomas Yau and others stated that while OPDIVO as a first-line treatment did not significantly improve overall survival compared to sorafenib monotherapy, its safety profile is manageable. OPDIVO may represent a new treatment option for patients who have risks associated with tyrosine kinase inhibitors or angiogenesis inhibitors.

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00604-5/fulltext

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