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CheckMate 040 Cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis

Journal of Hepatology May 29, 2021

Kudo M, Matilla A, Santoro A, et al. - Researchers present data from the Child-Pugh B cohort of CheckMate 040 [consisting of 6 cohorts, is a phase 1/2 study of nivolumab alone or combined with other agents in advanced hepatocellular carcinoma (aHCC) patients] who were managed with nivolumab alone. This work represents the first prospective analysis of immunotherapy in cases with Child-Pugh B aHCC. Until unacceptable toxicity or disease progression, patients were treated with intravenous nivolumab 240 mg every 2 weeks. Treatment was initiated in 25 sorafenib-naive and 24 sorafenib-treated patients between November 2016 and October 2017 (median follow-up, 16.3 months). An investigator-assessed objective response rate of 12% was reported, with six patients responding; a disease control rate of 55% was obtained. The median duration of response was noted to be 9.9 months. Findings revealed that clinical activity of nivolumab was evident as well as a favourable safety profile of it was reported with manageable toxicities, indicating its likely suitability for Child-Pugh B aHCC cases.

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