Key clinical point: Nivolumab vs. sorafenib led to clinically meaningful, but not statistically significant, overall survival and response rates in advanced HCC.
Major finding: Median overall survival was 16.4 vs. 14.7 months with nivolumab vs. sorafenib (HR, 0.85; P = .0752).
Study details: The phase 3 CheckMate 459 study of 743 patients.
Disclosures: CheckMate 459 was funded by Bristol-Myers Squibb. Dr. Yau is an advisor and/or consultant to Bristol-Myers Squibb, and reported honoraria from the company to his institution. Dr. Lamarca reported honoraria, consultation fees, travel funding, and/or education funding from Eisai, Nutricia, Ipsen, Pfizer, Bayer, AAA, Sirtex, Delcath, Novartis, and Mylan, as well as participation in company-sponsored speaker bureaus for Pfizer, Ipsen, Merck, and Incyte.
Yau T et al. ESMO 2019, Abstract LBA38-PR.
Sorafenib has been the standard systemic treatment for advanced hepatocellular carcinoma (HCC) for several years. However, more recently, other targeted agents and immunotherapies have been evaluated in the first- and second-line settings, with modest success. In line with many other cancers, immune checkpoint inhibitors are under evaluation in HCC, as well. Previously, nivolumab has been demonstrated to have efficacy against HCC in the second-line setting. In the phase III Checkmate-459 study, Yau et al. evaluated nivolumab and sorafenib in the first-line setting. The primary outcome, overall survival, was not statistically different between the two agents. Of note, there were no new safety signals identified in the nivolumab-treated group, which is encouraging, as nivolumab may result in increased liver function test values. This study suggests that nivolumab may be a consideration in the first- line setting for some patients with advanced HCC.—Mark A. Klein, MD