Zai Lab Limited Receives Breakthrough Therapy Designation For Bemarituzumab

Zai Lab has been granted therapy designation by the CDE to treat gastric and gastro esophageal cancers that overexpress fibroblast growth factor receptor 2. (FGFR2b)

FREMONT, CA: The National Medical Products Administration's Center for Drug Evaluation (CDE) has granted Zai Lab Limited Breakthrough Therapy Designation for investigational bemarituzumab (FPA144) as a first-line treatment for patients with FGFR2b overexpression and HER2-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).

Results from the Phase 2 FIGHT trial, which compared bemarituzumab plus chemotherapy (modified FOLFOX6) to chemotherapy alone in patients with FGFR2b overexpression and HER2-negative frontline advanced gastric or GEJ cancer, back up the designation. In the FIGHT trial, all three efficacy endpoints — PFS, OS, and ORR — achieved pre-specified statistical significance in the bemarituzumab arm versus the placebo arm. Additional study revealed a link between benefit and the prevalence of FGFR2b overexpression tumor cells, confirming the relevance of the FGFR2b target and bemarituzumab's effectiveness against it.

“In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab. 

In combination with chemotherapy, bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or GEJ cancer as a frontline therapy,” said Alan Sandler, M.D., president and head of global development, oncology, at Zai Lab. “We look forward to working with regulatory authorities in China as we advance bemarituzumab into global, registrational studies.”

More than one million new instances of stomach cancer are identified every year, with China accounting for over half of all cases. Approximately 30% of patients with advanced gastric and GEJ malignancies have FGFR2b overexpression, and almost 80% of these individuals are HER2-negative.

The Breakthrough Therapy Designation review policy is intended to encourage the development of drugs with obvious clinical benefits that are designed for the prevention or treatment of severe life-threatening diseases or diseases that have a significant impact on quality of life for which no existing treatment exists or where sufficient evidence indicates that the novel drug has advantages over existing treatments. The CDE prioritizes drugs that have been granted Breakthrough Therapy Designation in communications and receiving instructions to expedite medication development.