Second-line avelumab shows therapeutic potential in advanced HCC

Use of the antiprogrammed death ligand 1 (PD-L1) antibody avelumab in the second-line treatment of patients with advanced hepatocellular carcinoma (HCC) yields moderate efficacy with tolerable safety profile, according to the results of a phase II trial.

In total, 30 patients (median age, 62 years; 73.3 percent male) with Child-Pugh A score who had at least one measurable lesion received intravenous avelumab 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

Chronic HBV infection was the most common aetiology of HCC (n=26; 86.7 percent), followed by chronic HCV infection (n=3; 10.0 percent) and alcoholic liver disease (n=1; 3.3 percent). The most frequent sites of metastasis were liver (76.7 percent), lung (63.3 percent), lymph node (40.0 percent), and bone (13.3 percent). All 30 patients had prior treatment with sorafenib.

Over a median follow-up of 13.9 months, 27 progression events and 20 deaths occurred. Three patients (10.0 percent) achieved partial responses, 19 (63.3 percent) had stable disease, and none showed complete response.

Objective response rate was 10.0 percent, while disease control rate was 73.3 percent. The median time to progression (TTP) and overall survival (OS) were 4.4 and 14.2 months, respectively. PD-L1 expression did not modify avelumab response.

Prior duration of sorafenib treatment, when dichotomized by the median 2.7 months, was associated with treatment outcome, such that patients with longer sorafenib duration had longer TTP (6.5 vs 1.8 months; p=0.007) and OS (19.0 vs 7.8 months; p=0.006) with avelumab.

The study drug was well tolerated. There were seven cases of grade 3 adverse events, and none of the patients developed grade 4 events.