Amgen's Bemarituzumab Receives FDA Breakthrough Therapy Designation for First-Line Treatment of FGFR2b-Overexpressing Gastric Cancer; Zai Lab Holds Greater China Rights

Today, Amgen announced that the U.S. FDA has granted Breakthrough Therapy Designation to its investigational FGFR2b antibody therapy, bemarituzumab, in combination with chemotherapy, for the first-line treatment of patients with HER2-negative locally advanced or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma whose tumors overexpress FGFR2b in at least 10% of cells, as determined by an FDA-approved companion diagnostic test.

More than 1 million new cases of gastric cancer are diagnosed annually, with a particularly high incidence in Asia. Approximately 80–85% of patients with advanced gastric cancer and gastroesophageal junction (GEJ) cancer are HER2-negative, among whom approximately 30% overexpress FGFR2b.

Bemarituzumab is a monoclonal antibody targeting FGFR2b. It features a dual mechanism of action: it not only binds to FGFR2b to block the signaling of its mediated growth factors, but also kills cancer cells through antibody-dependent cell-mediated cytotoxicity (ADCC). In March this year, Amgen announced the acquisition of Five Prime Therapeutics, the developer of bemarituzumab, for approximately $1.9 billion. Zai Lab had previously entered into a collaboration agreement with Five Prime Therapeutics, securing the development rights for this innovative therapy in Greater China and taking responsibility for conducting clinical trials of the drug in the region.

▲Mechanism of Action of Bemarituzumab (Image source: Five Prime Therapeutics official website)

The granting of this breakthrough therapy designation is based on the positive results from the Phase 2 FIGHT clinical trial. In this study, bemarituzumab in combination with chemotherapy significantly improved progression-free survival and overall survival in the patient subgroup with at least 10% of tumor cells overexpressing FGFR2b. Further analysis revealed a positive correlation between clinical benefit and the proportion of FGFR2b-positive tumor cells.

“The FIGHT trial is the first study to evaluate targeting FGFR2b overexpression in cancer. As a first-line therapy, bemarituzumab provides clinically meaningful improvements in patients with advanced gastric and gastroesophageal junction (GEJ) cancers,” said Dr. David M. Reese, Executive Vice President of Research and Development at Amgen. “Amgen looks forward to further investigating the role of FGFR2b and will continue to collaborate with regulatory authorities to bring this potential first-in-class first-line therapy to patients.”

References:

[1] Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation. Retrieved April 19, 2021, from https://www.prnewswire.com/news-releases/amgens-investigational-targeted-treatment-bemarituzumab-granted-breakthrough-therapy-designation-301271859.html

Note: This article aims to introduce advances in medical and health research and does not constitute recommendations for treatment plans. For guidance on treatment options, please consult a qualified healthcare provider at a reputable hospital.

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