Elevar Therapeutics resubmits new drug application to FDA

FORT LEE, NJ, Sept. 23, 2024 (GLOBE NEWSWIRE) — Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment option for unresectable hepatocellular carcinoma (uHCC).

In May, the FDA issued a Complete Response Letter (CRL) for the original NDA, which was submitted in May 2023. The CRL cited GMP deficiencies at Hengrui Pharma's facility that manufactures camrelizumab, as well as incomplete Bioresearch Monitoring (BIMO) clinical inspections due to FDA travel restrictions. The FDA did not cite any issues related to clinical data or the manufacturing site for rivoceranib. During a Type A meeting with the FDA in July, the FDA confirmed that responses to observations at the Hengrui manufacturing site were sufficient, resubmission could proceed without further delay, and BIMO inspections could occur after resubmission.

“Elevar's timely resubmission of the NDA for the combination of camrelizumab and rivoceranib is a critical milestone in our mission to bring patients and healthcare providers a novel combination therapy for uHCC. HCC remains an area of ​​significant unmet medical need,” said Dr. Saeho Chong, CEO of Elevar Therapeutics. “This achievement would not have been possible without the extraordinary dedication of the teams at Elevar. We look forward to working with the FDA in the coming months as we focus on commercializing our combination therapy.”

The resubmission is supported by the landmark analysis of the Phase 3 CARES-310 trial presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1. It reported a median overall survival (mOS) of 23.8 months, the longest mOS of any treatment in a global Phase 3 trial for patients with uHCC, and confirmed that the combination of camrelizumab and rivoceranib continued to demonstrate sustained long-term survival as a first-line treatment for uHCC.

“The combination of camrelizumab and rivoceranib shows great promise as a potential therapy for patients with advanced hepatocellular carcinoma, with efficacy results generally consistent across subgroups,” commented Ahmed Omar Kaseb, MD, professor in the Division of Gastrointestinal Medical Oncology, Department of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “The resubmission is strengthened by the recent landmark CARES-310 analysis, which reported the longest median overall survival for any treatment in a global Phase 3 trial in the uHCC setting.”

About hepatocellular carcinoma

More than 800,000 people worldwide develop liver cancer every year^I and the disease is responsible for more than 830,000 deaths.ⁱⁱ Hepatocellular carcinoma (HCC) is the most common form of liver cancer and occurs most frequently in people with chronic liver inflammation, which can have viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and remains a diagnosis of ongoing urgent medical need.

About Rivoceranib

Rivoceranib, a small molecule tyrosine kinase inhibitor (TKI), is a potent inhibitor of the vascular endothelial growth factor receptor (VEGFR), a primary signaling pathway of tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being investigated as monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical trials include uHCC (in combination with camrelizumab), gastric cancer (as monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved for gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and has shown good tolerability in clinical trials with a safety profile comparable to other TKIs and VEGF inhibitors. It has been designated as an orphan drug for gastric cancer (US, EU and South Korea), adenoid cystic carcinoma (US) and uHCC (US and EU). Elevar Therapeutics, Inc. owns the worldwide rights (except China) to rivoceranib and has entered into a partnership with HLB-LS in South Korea for its development and commercialization. Rivoceranib is also approved in China under the name apatinib by the Chinese licensee Jiangsu Hengrui Pharmaceuticals Company Ltd. (Hengrui Pharma) under the brand name Aitan® for the treatment of advanced gastric cancer and advanced HCC in the second line of treatment.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed cell death 1 receptor (PD-1). Blockade of the PD-1/PD-L1 pathway is a therapeutic strategy that is successful in a wide range of solid and hematological cancers. Camrelizumab was developed by Hengrui Pharma and has been studied in more than 5,000 patients. 50 clinical trials are currently underway covering a wide range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment situations. Camrelizumab is currently approved in China under the brand name AiRuiKa® for eight indications, including as monotherapy for the treatment of HCC (second-line therapy), in combination with rivoceranib for the treatment of uHCC (first-line therapy), relapsed/refractory classical Hodgkin lymphoma (third-line therapy), esophageal squamous cell carcinoma (second-line therapy) and nasopharyngeal carcinoma (third-line therapy or further therapy), and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous cell carcinoma and squamous cell carcinoma), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted camrelizumab orphan drug designation for advanced HCC in April 2021 and the EMA in August 2024.

In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) for commercialization worldwide, excluding Greater China and Korea.

Media contact

Jeanette Bressi
Head of Corporate Communications, Elevar Therapeutics
[email protected]
609-439-3997

Investor Relations Contact

Wade Smith
Chief Financial Officer and Chief Operating Officer, Elevar Therapeutics
[email protected]

^I Key Liver Cancer Statistics | American Cancer Society
ⁱⁱ Key Liver Cancer Statistics | American Cancer Society