Amgen has shared positive results from a late-stage study of its investigational fibroblast growth factor receptor 2b (FGFR2b)-targeted monoclonal antibody bemarituzumab in gastric cancer.
The phase 3 FORTITUDE-101 trial, conducted with the support of Zai Lab, has been evaluating bemarituzumab plus mFOLFOX6 chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastro-oesophageal junction (G/GEJ) cancer in patients with FGFR2b protein overexpression.
Patients were excluded if they were known to be human epidermal growth factor receptor 2 (HER2) positive.
Results from a pre-specified interim analysis showed that the study met its primary endpoint, with bemarituzumab plus chemotherapy demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy.
Gastric cancer is the fifth leading cause of cancer-related deaths globally, with almost one million new cases diagnosed every year.
Approximately 38% of patients with advanced G/GEJ cancer have FGFR2b overexpression, which can play a significant role in tumour development and progression.
Jay Bradner, executive vice president of research and development at Amgen, 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 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”
A late-stage study evaluating bemarituzumab plus chemotherapy and Bristol Myers Squibb’s Opdivo (nivolumab) in patients with first-line gastric cancer is also ongoing, with data from the trial expected to be announced later this year.
Amgen gained access to bemarituzumab in 2021 through its $1.9bn acquisition of Five Prime Therapeutics. Zai Lab holds co-development and commercialisation rights for the drug in mainland China, Hong Kong, Macau and Taiwan.
Robert Bradway, chairman and chief executive officer at Amgen, said at the time of the March 2021 acquisition announcement: “We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realise the full potential of bemarituzumab for even more patients around the world as quickly as possible.”