Phase 3 data support camrelizumab plus rivoceranib as a new first-line treatment option for patients with unresectable hepatocellular carcinoma (uHCC), according to researchers.

Camrelizumab plus rivoceranib improved progression-free survival (PFS) and overall survival (OS), when compared with sorafenib, in a phase 3 trial of patients with uHCC.

This is the first phase 3 trial to report significant PFS and OS benefits with an anti-PD-1/L1 antibody and a small-molecule tyrosine kinase inhibitor vs sorafenib for uHCC, according to Shukui Qin, MD, of the Cancer Center of Jinling Hospital/Nanjing University of Chinese Medicine in China.


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In fact, camrelizumab-rivoceranib produced the longest OS seen to date in a frontline pivotal phase 3 study of advanced HCC, Dr Qin noted. He presented these results at ESMO Congress 2022.

The trial (ClinicalTrials.gov Identifier: NCT03764293) enrolled 543 patients with uHCC who were naïve to systemic therapy. The patients were randomly assigned to receive camrelizumab plus rivoceranib (n=272) or sorafenib (n=271). Camrelizumab was given at 200 mg every 2 weeks, and rivoceranib was given at 250 mg daily. Sorafenib was given at 400 mg sorafenib twice daily.

Most patients in both treatment arms were men ­­(83.5% in the combination arm and 84.9% in the monotherapy arm), had BCLC stage C disease (86.0% and 85.2%, respectively), and had HBV etiology (76.5% and 72.7%, respectively). The median ages were 58 years and 56 years, respectively, and 82.7% of patients in each arm were recruited in Asia.

The median PFS was 5.6 months in the camrelizumab-rivoceranib arm and 3.7 months in the sorafenib arm (hazard ratio [HR], 0.52; 95% CI, 0.41-0.65; P <.0001). In a subgroup analysis, PFS was superior with camrelizumab-rivoceranib across the groups.

The median OS was 22.1 months in the camrelizumab-rivoceranib arm and 15.2 months in the sorafenib arm (HR, 0.62; 95% CI, 0.49-0.80; P <.0001). OS was superior with the combination across subgroups.

The overall response rate, per RECIST v1.1, was 25.4% in the camrelizumab-rivoceranib arm and 5.9% in the sorafenib arm (P <.0001). The complete response rate was 1.1% and 0.4%, respectively. Roughly half of patients in each arm had stable disease (52.9% and 48.0%, respectively).

The overall response rate, per mRECIST, was 33.1% in the camrelizumab-rivoceranib arm and 10.0% in the sorafenib arm (P <.0001). The complete response rate was 5.1% and 1.1%, respectively, and the rates of stable disease were 45.2% and 46.1%, respectively.

The rates of treatment-related adverse events (TRAEs) were 97.4% in the camrelizumab-rivoceranib arm and 92.6% in the sorafenib arm. Grade 3-4 TRAEs occurred in 80.5% and 52.0% of patients, respectively.

There was 1 fatal TRAE in each arm. The cause of death in the camrelizumab-rivoceranib arm was multiple organ dysfunction syndrome. The cause of death in the sorafenib arm was respiratory failure and circulatory collapse.  

Disclosures: This research was supported by Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics Inc. Some of the study authors declared affiliations with Jiangsu Hengrui Pharmaceuticals. Please see the original reference for a full list of disclosures.

Reference

Qin S, Chan LS, Gu S, et al.Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): A randomized, phase III trial. Presented at ESMO 2022; September 9-13, 2022. Abstract LBA35.