First patient treated in mainland China for the global phase III FORTITUDE-101 study of bemarituzumab in first-line gastric cancer.- Zai Lab.

FORTITUDE-101 is a global trial of bemarituzumab in first-line gastric cancer sponsored by Amgen.

The FORTITUDE-101 study is a double-blind, placebo-controlled Phase III trial in patients with untreated, unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma not amenable to curative therapy. Adult patients with FGFR2b overexpression will be randomized to bemarituzumab plus chemotherapy (mFOLFOX6), versus placebo plus chemotherapy (mFOLFOX6).

“Approximately 30 percent of advanced HER2-negative gastric cancer patients are estimated to have FGFR2b overexpression, and currently, there are no approved treatments targeting FGFR2b in gastric cancer,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “We are focused on expanding treatment options to patients with advanced cancer, and we look forward to our continued partnership with Amgen to advance this global Phase III study and gain a greater understanding of the potential of bemarituzumab to impact gastric cancer treatment.”

Previously, Zai Lab collaborated with Five Prime Therapeutics, a company later acquired by Amgen, to evaluate bemarituzumab plus chemotherapy (modified FOLFOX6) as a frontline targeted treatment for FGFR2b+ gastric and GEJ cancers in the Phase II FIGHT study.

In early 2024, Zai Lab will join the Amgen-sponsored global Phase III FORTITUDE-102 study in first-line gastric cancer. This study is evaluating bemarituzumab plus chemotherapy and nivolumab, versus placebo plus chemotherapy and nivolumab for untreated advanced gastric and GEJ cancer with FGFR2b overexpression.