Elevar Therapeutics to Resubmit NDA for First-Line Hepatocellular Carcinoma Treatment

Elevar Therapeutics, Inc., a subsidiary of HLB Co., Ltd., recently outlined plans for the prompt resubmission of its New Drug Application (NDA) for rivoceranib combined with camrelizumab. This regimen is proposed as a first-line treatment for Unresectable Hepatocellular Carcinoma (uHCC). This announcement follows a Type A meeting held on July 2 with the FDA, which was initially requested by Jiangsu Hengrui Pharmaceuticals to address concerns highlighted in the FDA's Complete Response Letters (CRLs) issued on May 16, 2024.

The original NDA was submitted by Elevar in May 2023, but the CRLs pointed out 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 imposed by the FDA. Importantly, the FDA did not identify any issues with the clinical data or the manufacturing site for rivoceranib.

Prior to the meeting, the FDA had accepted Hengrui Pharma's written responses addressing the GMP deficiencies. During the meeting, the FDA confirmed that the resubmission of the NDA could proceed without delay. Additionally, BIMO inspections, hindered by travel restrictions, may occur post-resubmission.

Dr. Saeho Chong, CEO of Elevar, expressed enthusiasm about the meeting's outcomes, stating that it provided a clear path for resubmission. The resubmission will include the results from the CARES-310 study, a landmark analysis previously presented at ASCO, which showcased a median overall survival of 23.8 months, the longest recorded in a global Phase 3 trial for uHCC patients.

Hepatocellular carcinoma (HCC) is the most prevalent form of primary liver cancer, often arising in individuals with chronic liver inflammation from various causes. HCC is associated with a poor prognosis and limited treatment options, highlighting a significant unmet medical need.

The CARES-310 (NCT03764293) trial was an international Phase 3 study involving 543 patients with unresectable or metastatic HCC who had not received prior systemic treatment. Participants were randomized to receive either the combination of camrelizumab and rivoceranib or sorafenib, a standard first-line treatment for uHCC. Camrelizumab was administered intravenously while rivoceranib was given orally. Conducted across 95 sites in 13 countries, the study demonstrated that the combination therapy significantly improved overall survival, progression-free survival, and response rates compared to sorafenib. The co-primary endpoints were overall survival and progression-free survival, with secondary endpoints including objective response rate and duration of response.

Camrelizumab (SHR-1210) is a monoclonal antibody targeting the PD-1 receptor, a strategy effective across various cancers. It has been studied in over 5,000 patients and is approved for multiple indications in China, including first-line treatment for uHCC in combination with rivoceranib. The FDA granted it Orphan Drug Designation for advanced HCC in April 2021.

In October 2023, Elevar obtained global commercialization rights for camrelizumab from Hengrui Pharma, excluding Greater China and Korea. Rivoceranib, a potent VEGFR-2 inhibitor, is being evaluated as a monotherapy and in combination with other therapies for several cancers. It was the first tyrosine kinase inhibitor approved for gastric cancer in China and is also approved there for first-line treatment of uHCC in combination with camrelizumab. Rivoceranib has shown a favorable safety profile in clinical trials and has been granted orphan drug designations in several regions for various cancers.

Elevar Therapeutics is a biopharmaceutical company dedicated to developing treatments for patients with limited options. The company's lead drug candidate is rivoceranib. Elevar is based in New Jersey, with additional offices in South Korea.