Astellas Pharma, Inc. has posted its second positive Phase III trial readout for its first-in-class Claudin-18.2 antibody therapy in stomach cancer, moving a candidate the Japanese pharma has called vital to its strategy in gastric cancer treatment closer to filing for approval globally. Zolbetuximab (IMAB362) has met the primary endpoint of progression-free survival (PFS) as well as an overall survival secondary endpoint in the Phase III GLOW trial, Astellas reported on 16 December.
The primary asset in Astellas’s 2016 buyout of Germany’s Ganymed Pharmaceuticals AG for €422m, zolbetuximab is being tested in Claudin-18.2-positive, HER2-negative, locally advanced inoperable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. If approved, it would compete with Bristol Myers Squibb Company’s anti-PD-1 agent Opdivo (nivolumab) in first-line, HER2-negative stomach cancer
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