Elevar Therapeutics has resubmitted its FDA application for rivoceranib plus camrelizumab as a first-line treatment for unresectable liver cancer (HCC). Previous delays were due to manufacturing and inspection issues, not concerns about the drug’s safety or effectiveness.
The Phase 3 CARES-310 trial showed the combination significantly outperformed the former standard, sorafenib. Patients lived a median of 23.8 months versus 15.2 months with sorafenib, and the risk of disease progression was nearly halved. The overall response rate was also much higher at 26.8% compared with 5.9%.
The treatment has manageable side effects, including high blood pressure, hand-foot syndrome, and elevated liver enzymes. About 4% of patients had to stop both drugs due to side effects. If approved, this regimen could set a new benchmark for first-line therapy in advanced liver cancer.