Opdivo for HCC – pro
There is a small recent study that suggests efficacy of OPDIVO or for hepatocellular carcinoma. In patients with advanced hepatocellular carcinoma, treatment with nivolumab (Opdivo) resulted in responses and long-term survival in patients who were either previously treated or naive to sorafenib (Nexavar). CheckMate 040 enrolled 262 patients with advanced hepatocellular carcinoma, treating them with nivolumab at 0.1 to 10 mg/kg in the dose-escalation phase (n = 48) and at 3 mg/kg in the dose-expansion phase (n = 214). Previous treatment with sorafenib was allowed (70%), though some patients (30%) were sorafenib-naive. It showed that Opdivo monotherapy provided early, stable, and durable responses. Efficacy was observed irrespective of hepatitis C or B viral infection status, and responses were durable irrespective of PD-L1 [programmed cell death ligand 1] expression on tumor cells. Altogether 19% of patients responded to the antibody targeting programmed cell death protein 1 (PD-1), with a median duration of response of 17 months in the dose-escalation cohort and not reached in the expansion cohort. This exciting results.
The U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017. Recently it was fully approved under the accelerated approval program.
Melero I, Sangro B, Yau TC, et al: Nivolumab dose escalation and expansion in patients with advanced hepatocellular carcinoma: The CheckMate 040 study. 2017 Gastrointestinal Cancers Symposium. Abstract 226. Presented January 20, 2017.
Melero I, Sangro B, Yau T, et al., “Nivolumab dose escalation and expansion in patients with advanced hepatocellular carcinoma (HCC): The CheckMate 040 study;” J Clin Oncol, 35: (suppl 4S abstract 226), 2017.
Dr Anthony B El-Khoueiry et al, Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. The Lancet Volume 389, No. 10088, p24922502, 24 June 2017