Zai Lab (ZLAB) announced that the first patient has been treated in the mainland China portion of the global registrational, Phase 3 FORTITUDE-101 study for bemarituzumab, a potential first-in-class Fc-optimized monoclonal antibody that is designed to block fibroblast growth factors from binding and activating Fibroblast Growth Factor Receptor 2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing tumor proliferation. FORTITUDE-101 is a global trial of bemarituzumab in first-line gastric cancer sponsored by Amgen (AMGN). The FORTITUDE-101 study is a double-blind, placebo-controlled Phase 3 trial in patients with untreated, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma not amenable to curative therapy. Adult patients with FGFR2b overexpression will be randomized to bemarituzumab plus chemotherapy, versus placebo plus chemotherapy.
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