Transcenta Bags US FDA Nod For Trial of Osemitamab

Transcenta Holding Limited, a clinical stage biopharmaceutical company, announces that the FDA has approved the TranStar 301 global phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic G/GEJ adenocarcinoma. This clearance marks a major step forward in the global development of Osemitamab (TST001) and another important milestone following the approvals by the Center for Drug Evaluation (CDE) in China and MFDS in South Korea for the phase III pivotal trial of Osemitamab (TST001) in July 2023, as per pharma biz.

This landmark represents an important step forward in the development of Osemitamab (TST001) as a worldwide treatment that improves the existing standard of care for HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. Osemitamab (TST001), by selectively targeting CLDN18.2 and combining it with Nivolumab and chemotherapy, has the potential to alter the therapeutic paradigm for G/GEJ cancer. Stomach cancer is still a major cause of death worldwide, accounting for approximately one million new cases in 2020 and an anticipated 769,000 fatalities (equating to one in every 13 deaths), ranking fifth in incidence and fourth in fatality.

The backbone chemotherapy treatment for patients with HER2-negative advanced gastric cancer is a combination of platinum and fluoropyrimidine. Nivolumab was authorized for first-line treatment of patients with advanced or metastatic gastric cancer in conjunction with chemotherapy. Despite improvements in treatment results, the median overall survival of nivolumab with chemotherapy remains fewer than 14 months.