May 17, 2023: Rivoceranib / Camrelizumab / Unresectable HCC / Elevar Therapeutics: Submitted a New Drug Application to FDA
Elevar Therapeutics submitted NDA to the FDA based on results from the Phase 3 CARES 310 study
Phase 3 data of Rivoceranib + Camrelizumab showed statistically significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS) vs Sorafenib in 1L HCC setting
OS: 22.1 months vs 15.2 months
mPFS: 5.6 months vs 3.7 months
ORR: 25.4% vs 5.9%
“The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for advanced hepatocellular carcinoma,” said Ahmed Omar Kaseb, M.D., Professor, Department of Gastrointestinal Medical Oncology