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Unresectable Hepatocellular Carcinoma: Phase III Results Support Novel Doublet

By: Celeste L. Dixon
Posted: Monday, October 10, 2022

The combination of camrelizumab plus rivoceranib showed activity in the first-line treatment of unresectable hepatocellular carcinoma, based on the results of a randomized phase III trial. Shukui Qin, MD, PhD, of People’s Liberation Army 81 Hospital, Nanjing, China, and colleagues presented their findings during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA35). Versus sorafenib, camrelizumab plus rivoceranib significantly improved progression-free survival and overall survival, meeting the the study’s primary endpoints.

“This is the first positive pivotal trial to show survival benefits with a PD-1/PD-L1 inhibitor [camrelizumab] plus an antiangiogenic tyrosine kinase inhibitor [rivoceranib] for unresectable hepatocellular carcinoma,” the team stated. In this international, open-label trial, 543 patients were randomly assigned on a 1:1 basis to receive camrelizumab intravenously plus oral rivoceranib or oral sorafenib.

With a median follow-up of 7.8 months, median progression-free survival in the investigative versus control arms was 5.6 versus 3.7 months. The median follow-up for overall survival was 14.5 months, and the median overall survival for the investigative versus control arms was 22.1 versus 15.2 months. “The overall response rate, disease control rate, and duration of response were also better with camrelizumab plus rivoceranib versus sorafenib,” Dr. Qin and co-investigators reported.

Additionally, patients were stratified by macrovascular invasion and/or extrahepatic metastases, geographic region (Asia vs. elsewhere), and baseline serum alpha-fetoprotein level (< 400 vs. ≥ 400 ng/mL). A prespecified subgroup analysis showed that hazard ratios of progression-free and overall survival favored the experimental regimen in many of the subgroups, the team noted.

As for safety, grade 3 or higher treatment-related adverse events were reported in 80.9% and 52.4% of the patients given camrelizumab plus rivoceranib and sorafenib, respectively. These adverse events led to discontinuation of any treatment in 24.3% (of both agents in 3.7%) of patients in the experimental arm and in 4.5% of those taking sorafenib.

Disclosure: The study authors’ disclosure information can be found at ctimeetingtech.com.


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