FORT LEE, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the presentation of three posters at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Sept. 13-17. “The results to be presented at ESMO continue to support the safety and efficacy of rivoceranib in combination with camrelizumab as a first-line systemic treatment option for patients with hepatocellular carcinoma; as well as the potential of combining rivoceranib with other immune checkpoint inhibitors as a therapeutic option for many types of solid tumors,” commented Chris Galloway, M.D., senior vice president of clinical and medical affairs at Elevar Therapeutics. Camrelizumab and rivoceranib were granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medical Association. ESMO Presentation 985P (Abstract 5451): Analysis of antidrug antibodies (ADA) to camrelizumab in CARES-310: The pivotal phase III study of camrelizumab + rivoceranib in unresectable hepatocellular carcinoma (uHCC) The poster reports an analysis of antidrug antibodies (ADAs) in the CARES-310 (NCT03764293) Phase 3 clinical study for the treatment of unresectable hepatocellular carcinoma (uHCC). There was minimal impact of ADAs on PK, efficacy and safety. Therefore, follow-up monitoring of ADAs to cam is not warranted. CARES-310 was the first trial to demonstrate significant progression-free survival (PFS) and overall survival benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as a first-line treatment for uHCC. Speaker: Ahmed O. Kaseb (Houston, United States of America)Onsite poster display date: Mon., Sept. 16Link to Abstract 5451 / Presentation 985P ESMO Presentation 963P (Abstract 5635): Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis to assess the impact of treatment with camrelizumab + rivoceranib (cam+rivo) on quality-of-life vs sorafenib (sora) in patients (pts) with unresectable hepatocellular carcinoma (uHCC): Study CARES-310 The poster reports results from Phase 3 CARES-310 study, concluding cam + rivo had clinically meaningful quality-adjusted survival benefits over sorafenib. The higher incidence of adverse effects in patients treated with cam + rivo was likely due to longer time on treatment versus sorafenib. Speaker: Andrew Moon (Chapel Hill, United States of America)Onsite poster display date: Mon., Sept. 16Link to Abstract 5635 / Presentation 963P ESMO Presentation 1013P (Abstract 2318): A phase I study of rivoceranib combined with nivolumab in patients with unresectable or metastatic cancer The poster reports results from Phase 1 (NCT03396211) clinical study of rivoceranib plus nivolumab (rivo + nivo) in patients with advanced metastatic solid tumors. The study concluded that rivo + nivo demonstrated a manageable safety profile and promising antitumor efficacy across many solid tumors as measured by reduction in tumor burden over time. Further studies are needed to confirm the safety and efficacy of rivo + nivo therapy. Speaker: Neal S. Chawla (Duarte, United States of America)Onsite poster display date: Sat., Sept. 14Link to Abstract 2318 / Presentation 1013P About Hepatocellular Carcinoma More than 800,000 people worldwide are diagnosed with liver cancer each year. Liver cancer is a leading cause of cancer accounting for more than 700,000 deaths annually.[i] Hepatocellular Carcinoma (HCC) is the most common type of primary liver cancer. It most frequently develops in people with chronic underlying liver inflammation which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target 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 in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug 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. 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. and EU). 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 that binds to 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, etc.) 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), in combination with rivoceranib as a treatment for uHCC (first-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 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. Media Contact Jeanette Bressi Head, Corporate Communications, Elevar Therapeutics jbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade SmithChief Financial & Business Officer, Elevar Therapeuticswsmith@elevartherapeutics.com [i] Key Statistics About Liver Cancer | American Cancer Society
