The checkpoint inhibitor nivolumab has been shown to increase survival time in different types of cancers. Now, it appears it may also have a role in helping patients with advanced hepatocellular carcinoma (HCC). New data suggest that nivolumab may produce long-term benefits in sorafenib-experienced patients with advanced HCC.

Results from the CheckMate 040 study, presented at The International Liver Congress 2017, showed nivolumab produced durable responses with long-term survival rates, regardless of whether patients were infected with hepatitis B or C.

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The overall objective response rate (ORR) by blinded independent central review (BICR) was 14.5% and ORR by investigator assessment was 19.3% in sorafenib-experienced patients in the dose expansion phase of CheckMate 040, according to the researchers’ report. Responses by BICR were ongoing in 71.4% of patients and the 12-month overall survival (OS) rate in this cohort was 59.9%. The safety profile of nivolumab was manageable and consistent with that reported in other tumor types. 

Prognosis for patients with HCC is poor and the multikinase inhibitor sorafenib is the only approved systemic treatment. Currently, no standard of care is established for patients who are intolerant of sorafenib or the agent is contraindicated.

Of the 145 patients who had previously received sorafenib, 132 (91.0%) had disease progression and 12 (8.3%) were intolerant of the therapy. The median follow up was 12.9 months in this interim analysis of the dose expansion phase. The overall median OS was 16.7 months, and it was not reached in those with chronic viral hepatitis B and C. Responses to nivolumab occurred regardless of PD-1 ligand expression on tumor cells. 


1. Trojan J. Nivolumab in sorafenib-experienced patients with advanced hepatocellular carcinoma (HCC) with or without chronic viral hepatitis: CheckMate 040 study (GS010). Presented at: The International Liver Congress 2017; April 19-23, 2017; Amsterdam, The Netherlands.