Amgen’s stomach cancer drug has been granted a Breakthrough Therapy designation


The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation to Amgen’s bemarituzumab, which is used in first-line therapy for patients with metastatic and locally advanced adenocarcinoma of the esophagogastric junction (GEJ) in combination with modified FOLFOX6 therapy (fluoropyrimidine, leucovorin and oxaliplatin), the company reports.

“The FIGHT trial is the first trial aimed at evaluating factor 2b (FGFR2b) receptors in cancer. Bemarituzumab demonstrated clinically meaningful outcomes at key endpoints for patients with locally advanced gastric or esophagogastric cancer as a first-line therapy,” said David M. Reese, executive vice president of Research and Development at Amgen.

He noted that Amgen is “looking forward” to further exploring the role of FGFR2b in the treatment of certain types of oncologic diseases.
Every year, more than 1 million new cases of stomach cancer are diagnosed worldwide, and the disease is especially common in Asia. Approximately 80% to 85% of patients with advanced gastric and GEJ cancer are HER2-negative, and approximately 30% of these patients present with FGFR2b overexpression.

After sotorasib, bemarituzumab is an oncological asset in the Amgen portfolio.

The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b+, non-HER2 positive frontline advanced gastric or GEJ cancer.  Bemarituzumab therapy in combination with chemotherapy demonstrated clinically meaningful and significant improvements in the primary endpoint of progression-free survival (PFS) and the secondary endpoint of overall survival (OS) in a patient population in which at least 10% of tumor cells were overexpressing.