In a Chinese phase II study reported in The Lancet Oncology, Qin et al found that the programmed cell death protein 1 (PD-1) inhibitor camrelizumab showed activity in patients with previously treated advanced hepatocellular carcinoma.

Study Details

In the open-label multicenter trial, 217 evaluable pretreated patients were randomly assigned between November 2016 and November 2017 to receive camrelizumab at 3 mg/kg every 2 weeks (n = 109) or every 3 weeks (n = 108). Overall, 74% of patients had received one prior line of systemic therapy and 22% had received two or more. Extrahepatic metastases were present in 82% of patients. The primary endpoints were objective response on blinded independent central review and 6-month overall survival.

Efficacy Outcomes

Median follow-up was 12.5 months. Overall, objective responses (all partial responses) were observed in 32 patients (14.7%), including 13 (11.9%) in the every-2-week group and 19 (17.6%) in the every-3-week group. Median duration of response was not reached in the total population or either treatment group. Among all patients, responses were ongoing at last analysis in 56.3% of responders. Among all patients, stable disease was observed in an additional 64 patients (29.5%), yielding a disease control rate of 44.2%. Programmed cell death ligand 1 (PD-L1) expression data was available for 30 patients; response was achieved in 4 (36%) of 11 patients with PD-L1 expression ≥ 1% and in 2 (11%) of 19 patients with expression < 1%.  

Overall survival at 6 months was 74.4% among all patients, 75.9% in the every-2-week group, and 73.0% in the every-3-week group. Overall survival at 12 months was 55.9%, 59.6%, and 52.2%, and median overall survival was 13.8, 14.2, and 13.2 months, respectively.

Adverse Events

Among all patients, grade 3 or 4 treatment-related adverse events occurred in 22% of patients, with the most common being increased aspartate aminotransferase (5%) and decreased neutrophil count (3%). Select immune-related adverse events occurred in 83%, 80%, and 87% of patients, respectively, with the most common being reactive cutaneous capillary endothelial proliferation (67% of patients, all grade 1 or 2). Two deaths were considered to be potentially treatment-related, consisting of liver dysfunction in one patient and multiple organ failure in another.

The investigators concluded: “Camrelizumab showed antitumour activity in pretreated Chinese patients with advanced hepatocellular carcinoma, with manageable toxicities, and might represent a new treatment option for these patients.”

Shukui Qin, MD, of Cancer Centre of Jinling Hospital, Nanjing, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by Jiangsu Hengrui Medicine. For full disclosures of the study authors, visit thelancet.com.