China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the first patient dosing in the global regulatory Phase III FORTITUDE-101 trial for its drug candidate bemarituzumab, which is being studied for the treatment of first-line gastric cancer in China.
Bemarituzumab’s Mechanism and Potential Impact
Bemarituzumab is a potential first-in-class Fc-optimized monoclonal antibody (mAb) designed to block fibroblast growth factors from binding and activating Fibroblast Growth Factor Receptor 2b (FGFR2b). By inhibiting several downstream pro-tumor signaling pathways, bemarituzumab has the potential to slow tumor proliferation. Zai Lab holds exclusive rights to develop and commercialize bemarituzumab in Greater China, following a USD 44 million licensing deal with Five Prime Therapeutics, which was later acquired by Amgen in December 2017.
Design of the Phase III Trial
The double-blind, placebo-controlled Phase III trial is designed to assess the efficacy of bemarituzumab in patients with untreated, unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is not amenable to curative therapy. Adult patients with FGFR2b overexpression will be randomized to receive either bemarituzumab plus chemotherapy (mFOLFOX6) or placebo plus chemotherapy (mFOLFOX6).
Upcoming Global Phase III Study Participation
In early 2024, Zai Lab will participate in the global Phase III FORTITUDE-102 study for first-line gastric cancer. This study, sponsored by Amgen, will evaluate bemarituzumab in combination with chemotherapy and nivolumab versus placebo plus chemotherapy and nivolumab for untreated advanced gastric and GEJ cancer with FGFR2b overexpression.-Fineline Info & Tech
