Elevar Therapeutics and China-based partner, Jiangsu Hengrui Pharmaceuticals, received a second complete response letter (CRL) from the U.S. FDA regarding their combination treatment of rivoceranib and camrelizumab for hepatocellular carcinoma (HCC), the most common type of liver cancer.
After initially issuing a complete response letter in May 2024, the FDA had accepted Elevar’s new drug application resubmission in October 2024 for the first-line use of the oral VEGF TKI, rivoceranib, in combination with the PD-1 inhibitor, camrelizumab, for patients with unresectable or metastatic HCC.
The resubmission included the final analysis of the phase 3 CARES-310 study presented during the 2024 American Society of Clinical Oncology Annual Meeting, which reported median overall survival (mOS) of 23.8 months — the longest mOS for any treatment in a global phase 3 trial for patients with uHCC.
Yang Gon Jin, chairman of the board at HLB, Korean parent company to U.S.-based Elevar, appeared on the company's official YouTube channel to explain the most recent CRL, reported the Korean Biomedical Review.
According to Jin, Jiangsu had faced minor critiques during a chemistry, manufacturing, and controls (CMC) inspection, which they believed had been adequately addressed, but the FDA was not satisfied with Jiangsu's responses regarding the manufacturing process of camrelizumab. In addition, the agency indicated that due to travel restrictions, inspections of key clinical trial sites, primarily in Russia and Ukraine, had not been completed.
If approved, rivoceranib plus camrelizumab has the potential to change the clinical practice in the first-line setting for patients with advanced liver cancer. According to Jin, the partners plan to resubmit their application to the FDA.