The US Food and Drug Administration (FDA) has granted clearance to Transcenta to proceed with its TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) for gastric cancer.
The trial will investigate the drug in combination with Nivolumab and chemotherapy as a first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.
The company received approvals from the Center for Drug Evaluation (CDE) in China and MFDS in South Korea for the Phase III pivotal trial of Osemitamab in July 2023.
Though treatment outcomes for stomach cancer have improved, the median overall survival of nivolumab plus chemotherapy, the current standard of care, is still less than 14 months.
Osemitamab is a second-generation humanised CLDN18.2 targeting antibody with improved CLDN18.2 binding affinity and enhanced antibody-dependent cellular cytotoxicity (ADCC). It has shown anti-tumour activities in preclinical tumour models with a broad range of CLDN18.2 expression.
“We are delighted with the positive outcome of the EOP2 meeting,” said Dr Caroline Germa, Transcenta Executive Vice President, Global Medicine Development and Chief Medical Officer. “The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. Securing FDA endorsement on critical programme elements represents a pivotal milestone in advancing our Phase III trial in the US.”