Gastric cancer data move Astellas’ mAb a step closer to first-in-class submission

New Phase III data could point the way to global regulatory submissions next year for Astellas’ first-in-class CLDN18 inhibitor, which it obtained via a 2016 acquisition of a company that shares its co-founding team with BioNTech’s.

Astellas Pharma Inc. (Tokyo:4503) said Thursday that zolbetuximab plus chemotherapy significantly improved progression-free survival compared with placebo plus chemotherapy in the Phase III SPOTLIGHT trial to treat a subset of patients with gastric or gastroesophageal junction carcinoma. The study also showed a significant overall survival benefit, meeting a secondary endpoint...