2. Academic Validation
  3. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design

Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design

  • Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141.
Daniel Vt Catenacci 1,  Anteneh Tesfaye 2,  Mohamed Tejani 3,  Eric Cheung 4,  Peter Eisenberg 5,  Aaron J Scott 6,  Clarence Eng 7,  James Hnatyszyn 7,  Neyssa Marina 7,  Janine Powers 8,  Zev Wainberg 9
Affiliations

Affiliations

  • 1 University of Chicago Comprehensive Cancer Center, Chicago, IL, USA.
  • 2 Karmanos Cancer Center, Detroit, MI, USA.
  • 3 University of Rochester Medical Center, Rochester, NY, USA.
  • 4 Innovative Clinical Research Institute, Whittier, CA, USA.
  • 5 Marine Cancer Care, Greenbrae, CA, USA.
  • 6 University of Arizona Cancer Center, Tucson, AZ, USA.
  • 7 Five Prime Therapeutics Inc., South San Francisco, CA, USA.
  • 8 Nurix Inc., Alameda, CA, USA.
  • 9 University of California Los Angeles Medical Center (UCLA), Los Angeles, CA, USA.
PMID: 31094225 DOI: 10.2217/fon-2019-0141
Abstract

Bemarituzumab is an afucosylated monoclonal antibody against FGFR2b (a FGF receptor) with demonstrated monotherapy clinical activity in patients with late-line gastric Cancer whose tumors overexpress FGFR2b (NCT02318329). We describe the rationale and design of the FIGHT trial (NCT03343301), a global, randomized, double-blind, placebo-controlled Phase III study evaluating the role of bemarituzumab in patients with previously untreated, FGFR2b-overexpressing advanced gastroesophageal Cancer. Patients are randomized in a blinded fashion to the combination of mFOLFOX6 and bemarituzumab or mFOLFOX6 and placebo. Eligible patients are selected based on the presence of either FGFR2b protein overexpression determined by immunohistochemistry or FGFR2 gene amplification determined by circulating tumor DNA. The primary end point is overall survival, and secondary end points include progression-free survival, objective response rate and safety.

Keywords

FGFR2 amplification bemarituzumab; Phase III study design; gastric and esophageal adenocarcinoma.

Figures
Products
  • Cat. No.
    Product Name
    Description
    Target
    Research Area
  • HY-P99010
    99.50%, Anti-FGFR2b Antibody