"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said
More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in
Following sotorasib, bemarituzumab is the second asset in
The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b+, non-HER2 positive frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.
Bemarituzumab (anti-FGFR2b) is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.
Zai Lab (Shanghai) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage,
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1 Bray F, et al. CA Cancer J Clin. 2018;68:394–424.
2 Rawla P, et al. Prz Gastroenterol. 2019;14(1):26-38. doi:10.5114/pg.2018.80001.
3 Shitara K et al. NEJM. 2020; 382;25: 2419-30.
4 Wainberg ZA, et al. Presented at: ASCO Gastrointestinal Cancer Symposium;
5 U.S. Food and Drug Administration. Breakthrough Therapy. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy. Accessed
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