Dr Burgoyne on OS Data With Camrelizumab/Rivoceranib in Unresectable HCC

Adam M. Burgoyne, MD, PhD, associate clinical professor, medicine, the University of California San Diego, discusses updated efficacy and safety findings from the phase 3 CARES-310 trial (NCT03764293) investigating camrelizumab plus rivoceranib in patients with unresectable hepatocellular carcinoma (HCC), as well as considerations for future drug development and disease management in this patient population.

Final overall survival (OS) data from CARES-310, which were presented at the 2024 ASCO Annual Meeting, confirmed the OS benefit that was previously reported with camrelizumab plus rivoceranib vs sorafenib (Nexavar) in this patient population, Burgoyne says. However, the safety profile of camrelizumab plus rivoceranib raises concerns, as the rates of adverse effects associated with the combination appeared to be higher than those observed with FDA-approved regimens for patients with HCC, Burgoyne emphasizes. Therefore, if camrelizumab plus rivoceranib were to gain FDA approval for this patient population in the future, the safety profile of this combination would need to be weighed against the safety profiles of standard regimens, Burgoyne notes.

In July 2023, the FDA accepted for review a new drug application (NDA) seeking the approval of the combination as a frontline regimen for patients with unresectable HCC. This NDA was supported by prior findings from CARES-310. However, in May 2024, the FDA issued a complete response letter to the NDA.

In recent years, several developments have been made to propel the field of advanced HCC management forward, according to Burgoyne. Expanding the number of effective treatment combinations and positive clinical trials in this disease setting provides more opportunities for patients to access critical cancer care, Burgoyne explains. However, as novel agents and regimens come down the pike, individualized treatment selection will become increasingly critical, Burgoyne says. Oncologists should discuss the safety profiles of these regimens with patients and consider characteristics such as ECOG performance status and liver function, Burgoyne emphasizes. Overall, patients’ individual needs should influence and help refine the broadening HCC treatment paradigm, Burgoyne concludes.