Amgen and Zai Lab have reported that the Phase III FORTITUDE-101 trial, assessing bemarituzumab in combination with chemotherapy (mFOLFOX6), achieved its primary goal of overall survival (OS) in individuals with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer.
The combo showed OS improvement against placebo with chemotherapy in G/GEJ patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression, defined as 2+/3+ staining in at least 10% of tumour cells, as well as those who are non-human epidermal growth factor receptor 2 (HER2) positive.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The placebo-controlled, randomised, double-blind trial involved 547 subjects across 300 sites in 37 nations. It was designed to assess the combo as a first-line treatment for this patient group.
Its primary outcome measure is OS in those with FGFR2b ≥10% 2+/3+ tumour cell staining.
Key secondary outcome measures are overall response rate (ORR) and progression-free survival (PFS).
Notably, the trial incorporated more extensive ocular-related monitoring than earlier bemarituzumab trials.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataZai Lab, which holds joint development and commercialisation rights for the therapy in mainland China, Macau, Taiwan, and Hong Kong, supported the conduct of the FORTITUDE-101 trial.
Bemarituzumab has also received breakthrough therapy designation from the China Center for Drug Evaluation for treating FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma.
In addition to FORTITUDE-101, a Phase III trial of bemarituzumab with chemotherapy and nivolumab is underway for the first-line gastric cancer treatment, with data readout expected in the second half of 2025.
Amgen research and development executive vice-president Jay Bradner said: “Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates, and limited therapeutic options.
“These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase III FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”
