Elevar Therapeutics Seeks FDA Approval for Rivoceranib and Camrelizumab Combination in Unresectable Hepatocellular Carcinoma
核心洞察
Elevar Therapeutics (搜索) has submitted an NDA to the FDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (搜索) (uHCC).
The NDA submission is based on Phase 3 CARES 310 study results, which demonstrated statistically significant improvements in overall and progression-free survival compared to sorafenib.
The combination therapy showed a median overall survival of 22.1 months versus 15.2 months for sorafenib, with a hazard ratio of 0.62 (95% CI 0.49-0.80; p<0.0001).
Elevar Therapeutics (搜索) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for rivoceranib, an oral tyrosine kinase inhibitor (TKI), in combination with camrelizumab, a PD-1 (搜索) inhibitor, as a first-line treatment for unresectable hepatocellular carcinoma (搜索) (uHCC). This submission aims to address the urgent medical need for improved treatment options for patients with HCC (搜索), a condition associated with poor prognosis.
The NDA is supported by data from the Phase 3 CARES 310 study (NCT03764293), a randomized, open-label, international trial involving 543 patients across 95 study sites in 13 countries/regions. The study compared the combination of rivoceranib and camrelizumab to sorafenib, a standard first-line treatment for uHCC.
Significant Improvement in Overall Survival
The CARES 310 study demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) with the rivoceranib and camrelizumab combination. The median OS for the combination was 22.1 months (95% CI 19.1-27.2) compared to 15.2 months (95% CI 13.0-18.5) for sorafenib, with a hazard ratio of 0.62 (95% CI 0.49-0.80; 1-sided p<0.0001). Progression-free survival (PFS) was also significantly improved, with a median PFS of 5.6 months (95% CI 5.5-6.3) for the combination versus 3.7 months (95% CI 2.8-3.7) for sorafenib (HR 0.52, 95% CI 0.41-0.65; 1-sided p<0.0001).
Improved Overall Response Rate
The combination therapy also showed a significantly higher confirmed objective response rate (ORR) of 25.4% (95% CI 20.3-31.0) compared to 5.9% (3.4-9.4) for sorafenib. These efficacy results were generally consistent across all subgroups, suggesting a broad benefit in the global uHCC population, including those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC (搜索) cases.
Expert Commentary
"The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for advanced hepatocellular carcinoma (搜索)," said Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. "As an oncologist focused on evolving the standard of patient care in HCC (搜索), I am encouraged by Elevar’s NDA filing and look forward to the completion of the FDA’s review process."
Prior Approval in China
In February 2023, the combination therapy of rivoceranib and camrelizumab was approved by the National Medical Products Administration (NMPA) in China as a first-line treatment for liver cancer (搜索), marking a significant step forward in addressing this challenging disease.
About Rivoceranib and Camrelizumab
Rivoceranib is a highly potent, selective oral TKI that inhibits vascular endothelial growth factor receptor 2 (VEGFR-2 (搜索)), a key pathway in tumor angiogenesis. Camrelizumab is a humanized monoclonal antibody targeting the programmed death-1 (PD-1 (搜索)) receptor, blocking the PD-1/PD-L1 signaling pathway, a therapeutic strategy showing success in a wide variety of solid and hematological cancers.
Elevar Therapeutics (搜索) holds the global rights (excluding China) to rivoceranib and has partnered with HLB-LS in South Korea for its development and marketing. Camrelizumab is developed by Hengrui Pharma and is currently approved for eight indications in China.