Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers
Amgen announced updated results from the Phase 2 FIGHT trial for bemarituzumab, showing enhanced median overall survival (OS) of 19.2 months with the drug combined with chemotherapy compared to 13.5 months for chemotherapy alone in 155 patients. Notably, patients with over 10% FGFR2b-positive tumors had an OS of 25.4 months versus 11.1 months. Corneal adverse events were more common in the treatment arm (67.1% vs. 10.4%). These results were shared at the ASCO Annual Meeting, reinforcing the drug's potential as a first-in-class therapy for advanced gastric and gastroesophageal cancers, with plans for Phase 3 development.
- Bemarituzumab plus chemotherapy shows median overall survival of 19.2 months versus 13.5 months for chemotherapy alone.
- Patients with >10% FGFR2b-positive tumors experienced a median OS of 25.4 months.
- FDA granted Breakthrough Therapy Designation for bemarituzumab based on promising trial results.
- Higher incidence of corneal adverse events in bemarituzumab arm (67.1% vs. 10.4%).
THOUSAND OAKS, Calif., June 4, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced updated results for investigational bemarituzumab in combination with chemotherapy from the Phase 2 FIGHT trial. The trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or gastroesophageal junction cancers (GEJ). New data includes median overall survival (OS), a secondary endpoint that was reached with longer follow-up, as well as additional analyses of patient subgroups.
With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients (n=155, HR: 0.6;
The incidence of all grade adverse events was similar in the bemarituzumab plus chemotherapy and chemotherapy only arm of the study (
The results were presented today in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place virtually from June 4-8, 2021.
"Gastric cancer is the fourth leading cause of cancer death globally and
More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to
"These updated results further validate our work on the role of FGFR2b overexpression in gastroesophageal cancer and demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a clinically significant reduction in the risk of disease progression for patients whose tumors overexpress FGFR2b," said Daniel V.T. Catenacci, MD, PhD, medical oncologist and principal investigator at the University of Chicago.
In April 2021, bemarituzumab was granted Breakthrough Therapy Designation by the U.S. FDA based upon a subset of patients from the FIGHT trial who showed at least
About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a Phase 3 ready, potential first-in-class, investigational targeted antibody that is designed to block specific 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.
About FIGHT
The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative 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
About Amgen Oncology
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References
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; January 15-16, 2021; Online Virtual Scientific Program (Abstract LBA160 and oral presentation).
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