China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug Evaluation (CDE) and South Korea’s Ministry of Food and Drug Safety (MFDS) for their pipeline candidate osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. Both regulatory bodies have approved the plan for TranStar 301, a global Phase III pivotal trial that will assess a treatment regimen of osemitamab plus nivolumab (Opdivo) and chemotherapy as a first-line treatment for HER2-negative, CLDN18.2-expressing, locally advanced or metastatic gastric or gastroesophageal (GC/GEJ) adenocarcinoma.
Osemitamab’s Potential in Gastric Cancer Treatment
Osemitamab is a second-generation humanized CLDN18.2 targeting antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) that has shown promise in early clinical trials in combination with chemotherapy as a first-line treatment for GC/GEJ cancer. Transcenta presented early results at the recent American Society of Clinical Oncology (ASCO) 2023 annual meeting, which indicated that osemitamab produced a median progression-free survival of 9.9 months. This data supports the continued development and investigation of osemitamab in the global Phase III trial.
Regulatory Filings Under Review in the EU and US
As noted in Transcenta’s press release, regulatory filings for the same trial are also under review in the European Union and the United States. This indicates the global interest and potential impact of osemitamab in the treatment of gastric cancer, as the company seeks to expand access to this novel therapy for patients worldwide.-Fineline Info & Tech
