Transcenta Holdings Ltd (HKG: 6628), a leading biopharmaceutical company, has announced updated positive results from the cohort-G data of its drug candidate osemitamab (TST001) in combination with nivolumab and CAPOX for the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer at the 2024 European Society of Medical Oncology (ESMO) Congress. The treatment has been granted breakthrough therapy designation (BTD) by the National Medical Products Administration (NMPA) for the treatment of recurrent refractory hemophagocytic lymphohistiocytosis (R/R MAS), indicating its potential to address unmet medical needs.
In the study, patients with known CLDN18.2 and PD-L1 status exhibited a median progression-free survival (mPFS) of 14.2 months for those with high/medium CLDN18.2 expression, with a confirmed objective response rate (ORR) of 68%. Notably, the majority of these patients had PD-L1 CPS<5. The 12-month survival rate for the overall population was an impressive 73.8%.
Osemitamab (TST001) is a high-affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC), which has been recognized by the FDA with Orphan Drug Designation for the treatment of patients with G/GEJ and pancreatic cancer, highlighting its potential to transform treatment paradigms in these indications. – Flcube.com
