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Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label,

Shukui Qin¹, Zhenggang Ren², Zhiqiang Meng³

¹Cancer Centre of Jinling Hospital, Nanjing, China.

The Lancet. Oncology

|March 1, 2020

Abstract

Background:

Blocking the interaction between PD-1 and its ligands is a promising treatment strategy for advanced hepatocellular carcinoma. This study aimed to assess the antitumour activity and safety of the anti-PD-1 inhibitor camrelizumab in pretreated patients with advanced hepatocellular carcinoma.

Methods:

This is a multicentre, open-label, parallel-group, randomised, phase 2 trial done at 13 study sites in China. Eligible patients were aged 18 years and older with a histological or cytological diagnosis of advanced hepatocellular carcinoma, had progressed on or were intolerant to previous systemic treatment, and had an Eastern Cooperative Oncology Group performance score of 0-1. Patients were randomly assigned (1:1) to receive camrelizumab 3 mg/kg intravenously every 2 or 3 weeks, via a centralised interactive web-response system using block randomisation (block size of four). The primary endpoints were objective response (per blinded independent central review) and 6-month overall survival, in all randomly assigned patients who had at least one dose of study treatment. Safety was analysed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02989922, and follow-up is ongoing, but enrolment is closed.

Findings:

Between Nov 15, 2016, and Nov 16, 2017, 303 patients were screened for eligibility, of whom 220 eligible patients were randomly assigned and among whom 217 received camrelizumab (109 patients were given treatment every 2 weeks and 108 every 3 weeks). Median follow-up was 12·5 months (IQR 5·7-15·5). Objective response was reported in 32 (14·7%; 95% CI 10·3-20·2) of 217 patients. The overall survival probability at 6 months was 74·4% (95% CI 68·0-79·7)]. Grade 3 or 4 treatment-related adverse events occurred in 47 (22%) of 217 patients; the most common were increased aspartate aminotransferase (ten [5%]) and decreased neutrophil count (seven [3%]). Two deaths were judged by the investigators to be potentially treatment-related (one due to liver dysfunction and one due to multiple organ failure).

Interpretation:

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.

Funding:

Jiangsu Hengrui Medicine.

Insights

Camrelizumab demonstrated significant antitumour activity in patients with advanced hepatocellular carcinoma. This anti-PD-1 therapy showed manageable side effects, offering a potential new treatment option.

Area of Science:

Oncology
Immunotherapy
Hepatocellular Carcinoma Research

Background:

Immuno-oncology targeting PD-1/PD-L1 interactions is a key strategy for advanced hepatocellular carcinoma.
This study evaluates camrelizumab, an anti-PD-1 inhibitor, in pretreated patients with advanced liver cancer.

Purpose of the Study:

To assess the antitumour efficacy of camrelizumab in advanced hepatocellular carcinoma.
To evaluate the safety and tolerability profile of camrelizumab in this patient population.

Main Methods:

A multicentre, randomized, open-label phase 2 trial involving 220 patients in China.
Patients received camrelizumab 3 mg/kg intravenously every 2 or 3 weeks.
Primary endpoints included objective response and 6-month overall survival.

Main Results:

Objective response rate was 14.7% (95% CI 10.3-20.2) in 217 treated patients.
6-month overall survival probability was 74.4% (95% CI 68.0-79.7).
Grade 3/4 treatment-related adverse events occurred in 22% of patients, with increased AST and decreased neutrophils being most common.

Conclusions:

Camrelizumab exhibits antitumour activity in pretreated Chinese patients with advanced hepatocellular carcinoma.
The observed toxicities were manageable, suggesting camrelizumab as a potential new therapeutic option.

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