Elevar Resubmits NDA to FDA for Camrelizumab and Rivoceranib Combo for Unresectable Hepatocellular Carcinoma

FORT LEE, N.J., Sept. 23, 2024 — Elevar Therapeutics, Inc., a subsidiary of HLB Co., Ltd., has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug rivoceranib combined with camrelizumab, aimed at treating unresectable hepatocellular carcinoma (uHCC).

The resubmission follows the FDA's issuance of a Complete Response Letter (CRL) back in May, citing deficiencies in Good Manufacturing Practices (GMP) at the Hengrui Pharma facility, where camrelizumab is produced, as well as incomplete Bioresearch Monitoring (BIMO) clinical inspections due to travel restrictions. Importantly, there were no concerns regarding the clinical data or the manufacturing site for rivoceranib. Following a Type A meeting with the FDA in July, it was confirmed that the issues at the Hengrui manufacturing site had been addressed, allowing for the resubmission.

Dr. Saeho Chong, CEO of Elevar Therapeutics, emphasized the significance of this resubmission, highlighting the potential impact of the combination therapy for uHCC patients. He acknowledged the dedication of the Elevar teams and expressed eagerness to work with the FDA towards commercialization.

The resubmission is bolstered by findings from the Phase 3 CARES-310 study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study revealed a median overall survival (mOS) of 23.8 months, the longest mOS reported in a global Phase 3 trial for uHCC patients, underscoring the promise of the camrelizumab and rivoceranib combination as a first-line treatment.

Dr. Ahmed Omar Kaseb from the University of Texas MD Anderson Cancer Center noted the consistent efficacy results across all patient subgroups, reinforcing the potential of the combination therapy for advanced hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) remains a significant global health issue, with over 800,000 new cases diagnosed annually and more than 830,000 deaths. HCC is often linked to chronic liver inflammation from various causes, both viral and non-viral, and has limited treatment options, necessitating ongoing medical efforts to address this urgent need.

Rivoceranib is a potent tyrosine kinase inhibitor (TKI) targeting the vascular endothelial growth factor receptor (VEGFR), crucial in tumor angiogenesis. It has shown efficacy in various solid tumors, both as a monotherapy and in combination with other treatments. Rivoceranib has been approved in China for gastric cancer since November 2014 and in combination with camrelizumab for uHCC since January 2023. Elevar holds global rights to rivoceranib, excluding China, and collaborates with HLB-LS in South Korea for its development. The drug has been studied in over 6,000 patients globally, demonstrating a safety profile similar to other TKIs and VEGF inhibitors.

Camrelizumab, a humanized monoclonal antibody developed by Hengrui Pharma, targets the PD-1/PD-L1 pathway, a therapeutic strategy effective against a variety of cancers. It is currently approved in China for multiple indications, including as a monotherapy and in combination with rivoceranib for uHCC. Camrelizumab has been granted Orphan Drug Designation by the FDA for advanced HCC and continues to be studied in numerous clinical trials across different cancer types. Elevar licensed the global commercialization rights for camrelizumab from Hengrui Pharma, excluding Greater China and Korea.