Dr He on the Evaluation of Camrelizumab Plus Rivoceranib in Unresectable HCC

Aiwu Ruth He, MD, PhD, scientific lead, Liver & Biliary Cancers, MedStar Georgetown University Hospital, discusses the evaluation of camrelizumab plus rivoceranib in unresectable hepatocellular carcinoma (HCC).

The phase 3 CARES-310 trial (NCT03764293) evaluated treatment with the PD-1 inhibitor camrelizumab in combination with the VEGFR-2 inhibitor rivoceranib in patients with unresectable HCC. Evaluable patients were randomly assigned to receive the experimental combination vs the historical standard of care, sorafenib (Nexavar), in the frontline setting.

Notably, results from the randomized, open-label, international clinical trial were published in The Lancet on July 24, 2023. Treatment with the investigational combination produced a statistically significant improvement in median progression-free survival and overall survival (OS) vs sorafenib, He reports. At the interim analysis of OS, the median follow-up was 14.5 months (interquartile range, 9.1-18.7), and the median OS was 22.1 months (95% CI, 19.1-27.2) in the combination arm vs 15.2 months (95% CI, 13.0-18.5) with sorafenib (HR, 0.62; 95% CI, 0.49-0.80; 1-sided P less than .0001), He details.

Regarding safety, common grade 3/4 treatment-related adverse effects (TRAEs) seen with the combination included hypertension (camrelizumab plus rivoceranib, 38%; sorafenib, 15%), palmar-plantar erythrodysaesthesia syndrome (12%; 15%), increased aspartate aminotransferase (17%; 5%), and increased alanine aminotransferase (13%; 3%). Serious TRAEs occurred in 24% of patients with camrelizumab/rivoceranib vs 6% with sorafenib.

Upon further examination of the safety outcomes, data revealed that the combination of camrelizumab plus rivoceranib produced several toxicities commonly associated with anti-VEGFR therapies, with patients often experiencing hypertension and proteinuria, He states. Similarly, patients also experienced hand-foot syndrome and fatigue with the experimental regimen, He says, adding that these toxicities are associated with TKIs.