Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma

2023-07-17

临床结果免疫疗法孤儿药上市批准申请上市

FORT LEE, N.J., July 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date 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, Elevar chief executive officer. “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 significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC. Results from the randomized, open-label, international trial, which included 543 patients and was conducted at 95 study sites across 13 countries/regions, demonstrated median OS for camrelizumab + rivoceranib of 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5] for sorafenib; hazard ratio 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001. Median PFS for camrelizumab + rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]; 1-sided p<0.0001, and confirmed objective response rate for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib. With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases1. In February 2023, the combination therapy of rivoceranib and camrelizumab 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 mono and combination therapies in other tumor cell types. To learn more, visit ElevarTherapeutics.com. 1Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340. 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 Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), 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 currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in 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 was well tolerated in clinical trials with a comparable safety pro other TKIs and VEGF inhibitors VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, 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-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) 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. 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, is commercialized by Hengrui Pharma in China and was approved in China as a single agent for the treatment of gastric cancer (2014), a second-line treatment for advanced HCC (2020), and first-line treatment in combination with camrelizumab for uHCC (2023). It has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 6,000 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 is headquartered in New Jersey, with offices in Ireland and South Korea. Additional information is available at ElevarTherapeutics.com. Media Contact Rosemary Ostmann Phone: 201-615-7751 Email: rostmann@rosecomm.com