China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and chemotherapy as a first-line treatment for HER2-negative, CLDN18.2-expressing locally advanced or metastatic gastric cancer and gastric esophageal junction adenocarcinoma (GC/GEJC).
Clinical Background and Previous Approvals
Osemitamab is a second-generation humanized antibody targeting CLDN18.2, designed with enhanced antibody-dependent cellular cytotoxicity (ADCC). The candidate has already demonstrated promising results in early clinical trials, particularly when used in conjunction with chemotherapy for GC/GEJC. Notably, Transcenta presented early trial results at the recent American Society of Clinical Oncology (ASCO) 2023 annual meeting, indicating that osemitamab achieved a median progression-free survival of 9.9 months.
The monoclonal antibody also received Phase III clinical trial approvals in China and South Korea in July of this year, further solidifying its potential in the global market.-Fineline Info & Tech
