Nivolumab induces durable objective responses in advanced hepatocellular carcinoma


Patients with advanced hepatocellular carcinoma are commonly treated with Sorafenib, however outcomes remain poor. In the CheckMate 040 trial, advanced hepatocellular carcinoma patients with or without hepatitis C or B (HCV or HBV) infection and patients with or without previous sorafenib treatment were treated with nivolumab to assess treatment safety and efficacy. In the dose-escalation phase, in which patients were treated with a dose of 0.1-10 mg/kg every 2 weeks, 46 (96%) of 48 patients discontinued treatment, 42 (88%) of them due to disease progression. 12 (25%) of 48 patients had grade 3/4 treatment-related adverse events. Three (6%) patients had treatment-related serious adverse events (pemphigoid, adrenal insufficiency and liver disorder). In the dose-expansion phase, a nivolumab dose of 3 mg/kg was selected. The objective response rate of 214 patients was 20%, including three (1%) complete responses and 39 (18%) partial responses. PD-L1 expression levels were retrospectively assessed in 174 (81%) of 214 patients. In patients with PD-L1 expression ≥1%, objective responses were observed in nine (26%) of 34 patients; in patients with PD-L1 expression ≤1%, objective responses were observed in 26 (19%) of 140 patients. These results demonstrate that nivolumab treatment induces durable objective responses in patients with advanced hepatocellular carcinoma.

El-Khoueiry AB, Sangro B, Yau T, et al., Lancet. 2017. pii: S0140-6736(17)31046-2.

doi: 10.1016/S0140-6736(17)31046-2

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