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

被引：62

作者：

Catenacci, Daniel V. T. ^{[1
]}

Tesfaye, Anteneh ^{[2
]}

Tejani, Mohamed ^{[3
]}

Cheung, Eric ^{[4
]}

Eisenberg, Peter ^{[5
]}

Scott, Aaron J. ^{[6
]}

Eng, Clarence ^{[7
]}

Hnatyszyn, James ^{[7
]}

Marina, Neyssa ^{[7
]}

Powers, Janine ^{[8
]}

Wainberg, Zev ^{[9
]}

机构：

[1] Univ Chicago, Ctr Comprehens Canc, Chicago, IL 60637 USA

[2] Karmanos Canc Ctr, Detroit, MI USA

[3] Univ Rochester, Med Ctr, Rochester, NY 14642 USA

[4] Innovat Clin Res Inst, Whittier, CA USA

[5] Marine Canc Care, Greenbrae, CA USA

[6] Univ Arizona, Ctr Canc, Tucson, AZ USA

[7] Five Prime Therapeut Inc, San Francisco, CA USA

[8] Nurix Inc, Alameda, CA USA

[9] Univ Calif Los Angeles, Med Ctr, Los Angeles, CA 90024 USA

来源：

FUTURE ONCOLOGY | 2019年 / 15卷 / 18期

关键词：

FGFR2 amplification bemarituzumab; gastric and esophageal adenocarcinoma; Phase III study design; FIBROBLAST-GROWTH-FACTOR-RECEPTOR-2 GENE AMPLIFICATION; ADVANCED GASTRIC ADENOCARCINOMA; OPEN-LABEL; FGFR2; GROWTH; HER2; PLUS; CHEMOTHERAPY; MONOTHERAPY; SENSITIVITY;

D O I：

10.2217/fon-2019-0141

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：2073 / 2082

页数：10

共 50 条

[1] FGFR2 in gastric cancer: protein overexpression predicts gene amplification and high H-index predicts poor survival [J].

Ahn, Soomin ;

Lee, Jeeyun ;

Hong, Mineui ;

Kim, Seung Tae ;

Park, Se Hoon ;

Choi, Min Gew ;

Lee, Jun-Ho ;

Sohn, Tae Sung ;

Bae, Jae Moon ;

Kim, Sung ;

Jung, Sin-Ho ;

Kang, Won Ki ;

Kim, Kyoung-Mee .

MODERN PATHOLOGY, 2016, 29 (09) :1095-1103

[2] A randomized, double-blind, multicenter phase III study evaluating paclitaxel with and without RAD001 in patients with gastric cancer who have progressed after therapy [J].

Al-Batran, Salah-Eddin ;

Riera-Knorrenschild, Jorge ;

Pauligk, Claudia ;

Goetze, Thorsten Oliver ;

Hegewisch-Becker, Susanna ;

Seraphin, Jorg ;

Thuss-Patience, Peter C. ;

Kopp, Hans-Georg ;

Dechow, Tobias Nicolaas ;

Vogel, Arndt ;

Luley, Kim Barbara ;

Pink, Daniel ;

Stahl, Michael ;

Kullmann, Frank ;

Hebart, Holger Frithjof ;

Siveke, Jens T. ;

Egger, Matthias ;

Homann, Nils ;

Probst, Stephan ;

Lorenzen, Sylvie .

JOURNAL OF CLINICAL ONCOLOGY, 2017, 35 (04)

[3] Prospective Comprehensive Genomic Profiling of Advanced Gastric Carcinoma Cases Reveals Frequent Clinically Relevant Genomic Alterations and New Routes for Targeted Therapies [J].

Ali, Siraj M. ;

Sanford, Eric M. ;

Klempner, Samuel J. ;

Rubinson, Douglas A. ;

Wang, Kai ;

Palma, Norma A. ;

Chmielecki, Juliann ;

Yelensky, Roman ;

Palmer, Gary A. ;

Morosini, Deborah ;

Lipson, Doron ;

Catenacci, Daniel V. ;

Braiteh, Fadi ;

Erlich, Rachel ;

Stephens, Philip J. ;

Ross, Jeffrey S. ;

Ou, Sai-Hong Ignatius ;

Miller, Vincent A. .

ONCOLOGIST, 2015, 20 (05) :499-507

[4]

[Anonymous], 2018, J CLIN ONCOL S

[5]

[Anonymous], J CLIN ONCOL S

[6]

[Anonymous], J CLIN ONCOL S

[7]

[Anonymous], 2015, SEER STAT FACT SHEET

[8]

Asan U., 2017, NATURE, V541, P169, DOI [10.1038/nature20805, DOI 10.1038/NATURE20805]

[9] GP369, an FGFR2-IIIb-Specific Antibody, Exhibits Potent Antitumor Activity against Human Cancers Driven by Activated FGFR2 Signaling [J].

Bai, Ailin ;

Meetze, Kristan ;

Vo, Nhi Y. ;

Kollipara, Sriram ;

Mazsa, Elizabeth K. ;

Winston, William M. ;

Weiler, Solly ;

Poling, Laura L. ;

Chen, Ting ;

Ismail, Nesreen S. ;

Jiang, Jinwei ;

Lerner, Lorena ;

Gyuris, Jeno ;

Weng, Zhigang .

CANCER RESEARCH, 2010, 70 (19) :7630-7639

[10]

Bang YJ, 2010, LANCET, V376, P1302

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