Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., has recently announced that the U.S. Food and Drug Administration (FDA) has accepted their new drug application (NDA) for rivoceranib in combination with camrelizumab as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC). This is great news for patients and healthcare professionals as it provides another potential treatment option for this challenging condition.
The NDA was supported by clinical data from the Phase 3 CARES 310 study. This study showed that the combination of rivoceranib and camrelizumab resulted in significantly improved overall survival (OS), progression-free survival (PFS), and overall response rate compared to the standard first-line treatment, sorafenib. These findings are both statistically significant and clinically meaningful, suggesting that this combination therapy could be a game-changer for uHCC patients.
One particularly promising aspect of the study results is that the efficacy was consistent across all subgroups.