Nivolumab shows promise for advanced HCC
Nivolumab shows clinical activity in patients with advanced hepatocellular carcinoma (aHCC) with Child-Pugh B status, accompanied by a favourable safety profile and manageable side-effects, a recent study has found.
Researchers conducted a phase I/II open-label, noncomparative trial including 49 patients with Child-Pugh B aHCC, of whom 24 had previously been treated with sorafenib while 25 were naïve. Intravenous nivolumab was given every 2 weeks at 240-mg doses until unacceptable toxicity or disease progression. Objective response rate (ORR), as assessed by the investigator, and response duration were the primary endpoints.
Over a median follow-up of 16.3 months, six patients showed treatment response, yielding an ORR of 12 percent. The disease control rate was 55 percent. Patients took a median of 2.7 months to demonstrate treatment response, which lasted for a median of 9.9 months.
Safety of nivolumab was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events. Twenty-five patients (51 percent) experienced treatment-related adverse events (TRAEs), leading to the discontinuation of two participants (4 percent).
Hypertransaminasemia, amylase increase, and aspartate aminotransferase increase were the most common grade 3/4 TRAEs, each detected in two patients. Nevertheless, the safety profile of nivolumab in Child-Pugh B patients was similar to that in Child-Pugh A aHCC.
“The evidence from this study suggests that nivolumab shows clinical activity and an acceptable safety profile in patients with hepatocellular carcinoma with Child-Pugh B status who have mild to moderate impairment of liver function or liver decompensation that might rule out other therapies,” the researchers said.
“Further studies are warranted to assess the safety and efficacy of nivolumab in this patient population,” they added.