April 20, 2021
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FDA grants breakthrough therapy designation to bemarituzumab for gastric cancers

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The FDA granted breakthrough therapy designation to bemarituzumab for use with chemotherapy as first-line treatment of certain patients with gastrointestinal cancers, according to the agent’s manufacturer.

The designation applies to use of the agent in combination with modified FOLFOX6 by patients with fibroblast growth factor receptor 2b (FGFR2b)-overexpressing, HER2-negative metastatic or locally advanced gastric or gastroesophageal adenocarcinoma.

 The main entrance of FDA Building 1.
Source: Adobe Stock.

More than 1 million cases of gastric cancer are diagnosed each year. An estimated 80% to 85% of patients with advanced gastric or gastroesophageal cancers are HER2-negative, and about 30% of these cases involve FGFR2b overexpression.

Bemarituzumab (Amgen) is an investigational targeted antibody designed to block fibroblast growth factors from binding and activating FGFR2b.

The FIGHT trial evaluated bemarituzumab plus modified FOLFOX6 — which consists of fluoropyrimidine, leucovorin and oxaliplatin — vs. chemotherapy alone as first-line therapy for patients with FGFR2b-positive, non-HER2-positive advanced gastric or gastroesophageal cancers.

PFS among patients who had at least 10% of tumor cells overexpressing FGFR2b served as the primary endpoint. OS served as a secondary endpoint.

As Healio previously reported, results presented at this year’s Gastrointestinal Cancers Symposium showed statistically significant improvement in PFS and OS with bemarituzumab in this population.

Researchers also observed a positive correlation between benefit and prevalence of FGFR2b-positive tumor cells.

"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a company-issued press release. “Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a front-line therapy. Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, front-line therapy to patients.”