Apatinib Mesylate

Post-hoc analysis on survival outcomes for camrelizumab plus rivoceranib in patients with viral and non-viral hepatocellular carcinoma (HCC) demonstrated clinically meaningful overall survival and progression-free survival benefit for patients with hepatitis B or C viral infection HCC or non-viral HCCResults presented at ASCO GI January 24 showing favorable survival benefit of using camrelizumab plus rivoceranib as first-line treatment for patients with unresectable HCC, independent of etiology FORT LEE, N.J., Jan. 24, 2025 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a portfolio company of HLB Co., Ltd., today announced the results from a post-hoc analysis of the international CARES-310 study evaluating camrelizumab plus rivoceranib vs. sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC) of viral and non-viral etiology. The post-hoc analysis will be presented in a poster at the 2025 American Society of Clinical Oncology's annual Gastrointestinal Cancers Symposium (ASCO GI) on January 24. "This post-hoc analysis of uHCC patients treated with camrelizumab and rivoceranib demonstrated consistent survival benefits across subgroups with hepatitis B, hepatitis C and non-viral etiologies. The exploratory analysis revealed clinically meaningful improvements in both overall survival and progression-free survival, agnostic of the underlying etiology. Importantly, the safety profile of the combination therapy remained manageable and comparable across all subgroups," commented Chris Galloway, M.D., senior vice president of clinical development and medical affairs at Elevar. Results: Median overall survival (mOS) was longer with camrelizumab plus rivoceranib compared with sorafenib in patients with non-viral (HR 0.68 [95% CI 0.39, 1.19]), HCV (HR 0.37 [95% CI 0.162, 0.84]), and HBV etiologies (HR 0.70 [95% CI 0.55, 0.89]). Similarly, median progression free survival (mPFS) was longer with camrelizumab plus rivoceranib compared with sorafenib in patients with non-viral (HR 0.55 [95% CI 0.34, 0.91]), HCV (HR 0.50 [95% CI 0.23, 1.06]), and HBV etiologies (HR 0.57 [95% CI 0.45, 0.72])i. The analysis concluded camrelizumab plus rivoceranib in CARES-310 suggested clinically meaningful mOS benefit in non-viral and viral HCC vs sorafenib and provides assurance of clinical benefit for first line treatment to patients with uHCC independent of etiology.ii 2025 ASCO GI Poster Session Information Poster Session B, Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract: Clinical outcomes of camrelizumab + rivoceranib vs sorafenib (CARES-310) as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC) of non-viral and viral etiology. Abstract: 578Poster Bd#: C4Presenter: Rachna T. Shroff, MD, FASCO About CARES-310 The CARES-310 study, an international, randomized, open-label, Phase 3 trial, with 543 patients with uHCC who had not previously received systemic treatment was the first to demonstrate significant progression-free survival (PFS) and overall survival (OS) benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as first-line treatment for uHCC. In the primary analysis of PFS (data cut-off [DCO], May 10, 2021) and interim analysis of OS (DCO, Feb. 8, 2022), significant improvements were observed with camrelizumab (C; anti-PD-1 antibody) + rivoceranib (R; VEGFR2-TKI) vs. sorafenib (S). In the final analysis (FA) of the CARES-310 study, after an additional follow-up of ~16 months, median OS was significantly prolonged with C+R vs. S (23.8 mo [95% CI 20.6-27.2] vs. 15.2 mo [95% CI 13.2-18.5]; hazard ratio (HR) 0.64 [95% CI 0.52-0.79]; 1-sided p <0.0001). OS rate with C+R vs. S was 49.0% vs. 32.6% at 24 mo, and 37.7% vs. 24.8% at 36 mo. OS benefits with C+R was generally consistent across subgroups, regardless of geographical region, race, and etiology. Benefits in PFS, objective response rate (ORR) and duration of response (DoR) with C+R vs. S were also sustained after prolonged follow-up. Safety data aligned with the interim OS analysis, with no new signals noted. In the FA, C+R continued to show clinically meaningful survival improvement compared with S, with manageable safety. The extended follow-up further confirmed the favorable benefit-to-risk profile of C+R, supporting it as a new first-line treatment option for uHCC. About Hepatocellular Carcinoma Worldwide each year more than 800,000 people are diagnosed with liver cancer and the disease is the cause of more than 830,000 deaths. Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and 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 selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), 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. Several clinical studies were completed in patients with 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, under the name apatinib (Aitan®), was the first TKI approved in gastric cancer in China (October 2014). It was 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 for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and 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. Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), is the Chinese -territory license-holder of rivoceranib. 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 European Medicines Agency 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. About Elevar Therapeutics Elevar Therapeutics, Inc., a portfolio company of HLB Co., Ltd., is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for patients who have limited or inadequate therapeutic options. With expertise rooted in oncology, Elevar is focused on identifying and developing promising medicines for complex yet under-treated health conditions. Elevar’s lead proprietary drug candidate is rivoceranib. The NDA for rivoceranib in combination with camrelizumab as a therapy for advanced or metastatic hepatocellular carcinoma (HCC) is currently under review by the FDA with a PDUFA action date scheduled for March 20, 2025. Additional information is available at www.Elevar Therapeutics.com. About HLB Group The HLB Group is comprised of HLB Inc. (KOSDAQ:028300) and its affiliates with a diverse portfolio across biopharma, lifestyle, marine business, semiconductor and energy, united by the mission of improving all aspects of human life. Members of the HLB Group include HLB Innovation (KOSDAQ: 024850), HLB BioStep (KOSDAQ:278650), HLB Pharmaceutical (KOSDAQ:047920), HLB Life Science (KOSDAQ:067630), HLB Therapeutics (KOSDAQ:115450), HLB Panagene (KOSDAQ:046210) and HLB Global (KOSDAQ:003580). HLB Group’s overseas affiliates include Elevar Therapeutics, Immunomic Therapeutics, a nucleic acid immunotherapy platform company, and Verismo Therapeutics, a CAR T platform oncology company, all of which are based in the United States. Media Contact Jeanette Bressi Head, Corporate Communications, Elevar Therapeutics jbressi@elevartherapeutics.com Investor Relations Wade Smith Chief Financial & Business Officer, Elevar Therapeutics wsmith@elevartherapeutics.com ________________________i 2025 ASCO GI Poster Session: Clinical outcomes of camrelizumab + rivoceranib vs sorafenib (CARES-310) as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC) of non-viral and viral etiology.ii 2025 ASCO GI Poster Session: Clinical outcomes of camrelizumab + rivoceranib vs sorafenib (CARES-310) as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC) of non-viral and viral etiology.

The biotech plans to submit a new drug application to China regulators in the first half of this year.\n CARsgen Therapeutics’ CAR-T improved progression-free survival (PFS) compared to approved therapies for patients with advanced stomach cancer in a phase 2 trial.The open-label study assessed CT041-ST-01, also known as satricabtagene autoleucel or satri-cel, a cell therapy that has nabbed the attention of both big biotech Moderna and was previously subject to an FDA hold due to manufacturing issues.Now, China-based CARsgen has shared pivotal results from the latter portion of a phase 1/2 study evaluating the therapy for patients with gastric or gastroesophageal junction cancers that haven’t responded to at least two prior lines of treatment.The study hit its primary goal of statistically significant improvement in PFS for patients receiving satri-cel compared to those receiving their physician\'s choice of an approved treatment, according to a Dec. 30 release. The company didn’t share specific data figures for either PFS or the statistical significance p-value.Trial participants, which all had Claudin18.2 expression-positive cancer, were randomized to receive either satri-cel infusion or their physician\'s choice of paclitaxel, docetaxel, irinotecan, apatinib or nivolumab. Satri-cel is designed to target the protein Claudin18.2 with the potential of becoming the first-in-class autologous CAR T-cell product to do so, according to CARsgen. Earlier data demonstrated a manageable safety profile for satri-cel, the biotech said in the release.  “This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors,” CARsgen CEO, Chief Scientific Officer and founder Zonghai Li, M.D., Ph.D., said in the release.The biotech plans to submit a new drug application to China regulators in the first half of this year, Li said. The asset has also snagged both orphan drug and regenerative medicine advance therapy tags from the FDA in the indication.CARsgen is already studying satri-cel in a phase 1 pancreatic cancer trial and a phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma.  Over the last five days, the company’s stock has risen 10%, hitting 9.38 Hong Kong dollars per share on the Hong Kong stock exchange as of 10:30 a.m. ET on Jan. 2. Back in August 2023, the biotech teamed up with Moderna to “contemplate conducting preclinical studies and a phase 1 clinical trial” for satri-cel in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine, according to a release at the time. An update on the partnership hasn’t been publicly shared yet.Then, at the end of 2023, three clinical trials for CARsgen’s cell therapies—including satri-cel—were hit by an FDA hold after the regulatory agency visited the company’s manufacturing facility. The biotech didn’t share what the FDA found at its North Carolina site at the time. The hold was lifted nearly a year later in November 2024.