Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design-Reference-Cited by-同舟云学术

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

Published:2019-06 Issue:18 Volume:15 Page:2073-2082
ISSN:1479-6694
Container-title:Future Oncology
language:en
Short-container-title:Future Oncology

Author:

Catenacci Daniel VT¹,Tesfaye Anteneh²,Tejani Mohamed³,Cheung Eric⁴,Eisenberg Peter⁵,Scott Aaron J⁶,Eng Clarence⁷,Hnatyszyn James⁷,Marina Neyssa⁷,Powers Janine⁸,Wainberg Zev⁹

Affiliation:

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

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.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/fon-2019-0141

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