Elevar Therapeutics Announces Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option
SALT LAKE CITY (Oct. 11, 2022) – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib in combination with camrelizumab as a treatment option for hepatocellular carcinoma (HCC), the most common type of liver cancer and cause of more than 830,000 annual deaths worldwide. The meeting reaffirmed Elevar’s plans to file an NDA for the combination of rivoceranib plus camrelizumab as early as is feasible in 2023.
Also, Elevar remains committed to filing an NDA for rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC) by the end of 2022.
“Our team at Elevar is very pleased with the results of our pre-NDA meeting with respect to rivoceranib plus camrelizumab as a treatment option for HCC, continuing a collaborative process with the FDA that allows us to maintain our timeline for the upcoming rivoceranib FDA filings in two indications with clearly demonstrated unmet medical need,” said Saeho Chong, chief executive officer of Elevar. “As evidenced by data shared this year, rivoceranib is proving to be efficacious in both monotherapy, for ACC, and in combination with an anti-PD1 inhibitor, for HCC, and we are excited to continue its regulatory development in the months ahead.”
Elevar in September announced during the annual Congress of the European Society for Medical Oncology (ESMO) that in a Phase 3 study, camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for unresectable HCC.
With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global unresectable HCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology, which comprises the majority of U.S. HCC cases1.
In June, Elevar announced at the American Society of Clinical Oncology (ASCO) annual meeting that in its Phase 2 clinical trial (Study RM-202) of rivoceranib monotherapy in patients with progressive recurrent or metastatic ACC, rivoceranib demonstrated clinical effectiveness, as indicated by substantially reduced tumor progression during the six months after rivoceranib treatment compared to the tumor progression during the six months prior to rivoceranib treatment.
1. Yoshizawa H. Hepatocellular carcinoma associated with hepatitis C virus infection in Japan: Projection to other countries in the foreseeable future. Oncology. 2002;62(Suppl 1):8–17. [PubMed: 11868791]; El-Serag HB, Rudolph KL. Hepatocellular carcinoma: Epidemiology and molecular carcinogenesis. Gastroenterology. 2007;132:2557–76. [PubMed: 17570226]
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
About Adenoid Cystic Carcinoma (ACC)
Adenoid Cystic Carcinoma (ACC) is a rare malignancy that occurs within the secretory glands, most commonly in the major and minor salivary glands of the head and neck, but also found in the breast, skin and elsewhere. It is diagnosed in about 4 of every 1 million people each year – representing a combined 3,100 annual cases in the U.S., EU and Japan – and it afflicts more than 200,000 patients throughout the world, accounting for 5-7% of all head and neck malignancies, according to the Adenoid Cystic Carcinoma Research Foundation. There is no approved standard of care for R/M ACC patients. A previous study showed a baseline progression-free survival of 2.8 months for ACC (Kang EJ, et al. Clin Cancer Res. 2021;27:5272-5279).
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer et al.) and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further), and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) approved in gastric cancer in China (November 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is co-developed by Hengrui Pharma in China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Clinical studies are ongoing in multiple solid tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (HCC) (in combination with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf®). Orphan Drug Designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Hengrui Pharma, under the brand name Aitan®.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib and paclitaxel micellar (Apealea®). Rivoceranib, under the name apatinib in China, was developed by Hengrui Pharma in China and approved in China as a single agent for treatment of gastric cancer in 2014 and second-line advanced HCC in 2020. It has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 1,000 patients worldwide in numerous cancer indications. Apealea® is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar has offices in Utah, California, Ireland and South Korea. Additional information is available at ElevarTherapeutics.com.