FORT LEE, NJ, July 17, 2023 (GLOBE NEWSWIRE) — Elevar Therapeutics, Inc., a majority owned subsidiary of HLB Co., Ltd., is a fully integrated biopharmaceutical company dedicated to improving treatment experiences and patient outcomes who have limited or inadequate treatment options, announced today that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1, as a first-line therapeutic option for unresectable hepatocellular carcinoma (uHCC). The FDA has assigned an action date under the Prescription Drug User Fee Act (PDUFA) of May 16, 2024.
Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma, said Saeho Chong, chief executive officer of Elevar. With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy. We look forward to working closely with the FDA during this review process and are focused on making the combination commercially available as quickly as possible should we gain approval.
The NDA is supported by clinical data from the Phase 3 CARES 310 study (NCT03764293), in which rivoceranib plus camrelizumab demonstrated statistically and clinically significant prolonged overall survival (OS) and progression-free survival (PFS) and response rate overall improved compared with sorafenib, a standard first-line treatment for uHCC.
Results from the international, randomized, open-label study that included 543 patients and was conducted at 95 study centers in 13 countries/regions demonstrated a median OS for camrelizumab + rivoceranib of 22.1 months. [95% CI 19.1-27.2] compared to 15.2 months. [13.0-18.5] for sorafenib; hazard ratio 0.62 [95% CI 0.49-0.80]; 1 tailed p<0.0001. The median PFS for camrelizumab + rivoceranib was 5.6 months. [95% CI 5.5-6.3] compared to 3.7 months. [2.8-3.7]; FC 0.52 [95% CI 0.41-0.65]; p<0.0001 1-sided and the confirmed objective response rate for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared with 5.9% (3.4-9.4) for sorafenib.
With generally consistent efficacy results across all subgroups, the data suggested that the combination confers an advantage in an overall uHCC population. Furthermore, it has demonstrated efficacy among those with hepatitis C virus-based aetiology and non-viral aetiology, which includes the majority of HCC cases in the United States1.
In February 2023, rivoceranib and camrelizumab combination therapy was approved by the National Medical Products Administration (NMPA) as a first-line treatment for liver cancer in China.
Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC) and as monotherapy and combination therapy in other cancer cell types.
To find out more, visit ElevarTherapeutics.com.
1Ghouri YA, Mian I, Rowe JH. Hepatocellular carcinoma review: Epidemiology, etiology, and carcinogenesis. J Carcinog. May 29, 2017; 16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMC ID: PMC5490340.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It occurs most frequently in people with chronic liver disease, 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 Rivoceranib
Rivoceranib, a small molecule tyrosine kinase inhibitor (TKI), is a very 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 currently being studied 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 (in monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (in 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 as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and has been well tolerated in clinical trials with a safety profile comparable to other TKI and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (US, EU and South Korea), adenoid cystic carcinoma (US) and uHCC (US).
Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has collaborated in its development and commercialization with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and for second-line advanced HCC from the license holder in China, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death receptor-1 (PD-1). Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematologic cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. There are currently 50 clinical trials underway across a wide range of cancers (including liver cancer, lung cancer, gastric cancer, and breast cancer) 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 classical Hodgkins lymphoma (third line), esophageal squamous cell carcinoma (second line), and nasopharyngeal carcinoma (third line). line) line or above) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), squamous cell carcinoma of the esophagus and nasopharyngeal cancer in first-line. The U.S. Food and Drug Administration granted orphan drug designation to camrelizumab for advanced HCC in April 2021.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company founded on the promise of improving treatment experiences and outcomes for patients with limited or inadequate treatment options. Elevars’ main drug candidates include rivoceranib and micellar paclitaxel (Apealea).
Rivoceranib, under the name of apatinib in China, is marketed by Hengrui Pharma in China and has been approved in China as a single agent for the treatment of gastric cancer (2014), second-line treatment for advanced HCC (2020), and first-line treatment of line in combination with camrelizumab for uHCC (2023). It has been granted orphan drug designation in the United States, Europe and South Korea and has been clinically tested in over 6,000 patients worldwide for numerous cancer indications.
Apealea is a non-Cremophor EL-based paclitaxel formulation that received marketing authorization from the European Commission in November 2018, making it the first European non-Cremophor EL paclitaxel formulation approved for use in ovarian cancer. Elevar is headquartered in New Jersey, with offices in Ireland and South Korea.
More information is available at ElevarTherapeutics.com.
Contact with the media
Rosemary Ostmann
Phone: 201-615-7751
Email: [email protected]
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