The latest results from the CheckMate 040 study showed that the programmed cell death ligand 1 (PD-L1) checkpoint inhibitor nivolumab produces durable responses with promising long-term survival rates in patients with advanced, unresectable hepatocellular carcinoma (HCC), regardless of hepatitis B and C status.
The updated interim data were presented at the International Liver Congress 2017 in Amsterdam.
The overall objective response rate by blinded independent central review was 14.5%, with responses ongoing in 15 of 21 patients (71.4%) and a 12-month overall survival rate of 59.9%. Responses to nivolumab occurred regardless of PD-L1 tumor expression.
The overall objective response rate was 19.3% by investigator assessment. Grade 3/4 adverse events related to nivolumab occurred in 16.6% of patients.
“The durable responses and survival rates that were achieved with nivolumab are very welcome, especially as the side effects were manageable,” said study author Bruno Sangro, MD, PhD, of the Clinica Universidad de Navarra in Spain, in a press release. “These data support the potential of nivolumab in the treatment and stabilization of advanced liver cancer in those patients who have progressed on sorafenib, with or without chronic viral hepatitis.”
The dose-expansion portion of the phase I/II CheckMate 040 trial included 145 advanced HCC patients who were previously treated with sorafenib; 132 of these patients (91%) had progressed on sorafenib and 12 patients (8.3%) were intolerant. All were treated with 3 mg/kg intravenous nivolumab every 2 weeks until disease progression or toxicity.
With a median follow-up of 12.9 months, the median duration of response was not yet reached. Of the 21 patients who responded to nivolumab, eight had a response that lasted longer than 12 months. The median overall survival rate was 16.7 months, and was not reached in patients with chronic hepatitis B and C infections.
“The reported median survival of 16.7 months in patients previously treated with sorafenib is promising and it encourages the evaluation of nivolumab in patients affected with HCC,” said Alejandro Forner, MD, PhD, of the Hospital Clinic Barcelona in Spain, in the press release.