Dr Vogel on Updated OS Data for Frontline Camrelizumab Plus Rivoceranib in Unresectable HCC

Arndt Vogel, MD, managing senior consultant, professor, Department of Gastroenterology, Hepatology and Endocrinology, head, Gastrointestinal Cancer Center, head, Center for Personalized Medicine, Hannover Medical School, discusses key findings from and implications of the final overall survival (OS) analysis of the phase 3 CARES-310 trial (NCT03764293) investigating the first-line combination of camrelizumab and rivoceranib in patients with unresectable hepatocellular carcinoma (HCC).

In July 2023, the FDA accepted for review a new drug application (NDA) seeking the approval of rivoceranib in combination with camrelizumab as a first-line treatment option for patients with unresectable HCC, based on prior data from CARES-310. However, in May 2024, the regulatory agency issued a complete response letter (CRL) to the NDA. The CRL cited deficiencies related to the FDA’s inspection of the developer’s manufacturing site.

Findings presented at the 2024 ASCO Annual Meeting demonstrated that frontline treatment with rivoceranib plus camrelizumab maintained a clinically meaningful survival improvement compared with sorafenib (Nexavar) alone. Findings from the final analysis of CARES-310 trial showed that at a median follow-up of 22.1 months in the combination arm and 14.9 months in the sorafenib arm, the median overall survival (OS) was 23.8 months (95% CI, 20.6-27.2) in the combination arm (n = 272) vs 15.2 months (95% CI, 13.2-18.5) in the sorafenib arm (n = 271; HR, 0.64; 95% CI, 0.52-0.79; 1-sided P <.0001).

At 24 and 36 months, the respective OS rates were 49.0% and 37.7% for rivoceranib/camrelizumab vs 32.6% and 24.8% for sorafenib. These rates were similar between most subgroups, regardless of geographical race, region, and etiology.

Vogel notes that the combination of rivoceranib plus camrelizumab showed, sustained, clinically meaningful survival improvement compared with sorafenib, with manageable safety. The extended follow-up further confirmed the favorable benefit-to-risk profile of rivoceranib plus camrelizumab, supporting it as a new first-line treatment option for unresectable HCC.

He concludes by noting that the efficacy and safety data displayed by the combination could support its approval to add another option to the frontline setting for patients with unresectable HCC.