Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial

Shalini Makawita; Ghassan K Abou-Alfa; Sameek Roychowdhury; Saeed Sadeghi; Ivan Borbath; Lipika Goyal; Allen Cohn; Angela Lamarca; Do Youn Oh; Teresa MacArulla; Rachna T Shroff; Michael Howland; Ai Li; Terry Cho; Amit Pande; Milind Javle

doi:10.2217/fon-2020-0299

Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial

Shalini Makawita, Ghassan K Abou-Alfa, Sameek Roychowdhury, Saeed Sadeghi, Ivan Borbath, Lipika Goyal, Allen Cohn, Angela Lamarca, Do Youn Oh, Teresa MacArulla, Rachna T Shroff, Michael Howland, Ai Li, Terry Cho, Amit Pande, Milind Javle

GI Medical Oncology

Research output: Contribution to journal › Review article › peer-review

56 Scopus citations

Abstract

Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients.

Original language	English (US)
Pages (from-to)	2375-2384
Number of pages	10
Journal	Future Oncology
Volume	16
Issue number	30
DOIs	https://doi.org/10.2217/fon-2020-0299
State	Published - Oct 2020

Keywords

cholangiocarcinoma
fibroblast growth factor receptor inhibitor
infigratinib
targeted therapy

ASJC Scopus subject areas

Oncology
Cancer Research

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Makawita, S., K Abou-Alfa, G., Roychowdhury, S., Sadeghi, S., Borbath, I., Goyal, L., Cohn, A., Lamarca, A., Oh, D. Y., MacArulla, T., T Shroff, R., Howland, M., Li, A., Cho, T., Pande, A., & Javle, M. (2020). Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial. Future Oncology, 16(30), 2375-2384. https://doi.org/10.2217/fon-2020-0299

Makawita, S, K Abou-Alfa, G, Roychowdhury, S, Sadeghi, S, Borbath, I, Goyal, L, Cohn, A, Lamarca, A, Oh, DY, MacArulla, T, T Shroff, R, Howland, M, Li, A, Cho, T, Pande, A & Javle, M 2020, 'Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial', Future Oncology, vol. 16, no. 30, pp. 2375-2384. https://doi.org/10.2217/fon-2020-0299

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abstract = "Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients.",

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doi = "10.2217/fon-2020-0299",

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AU - Roychowdhury, Sameek

AU - Sadeghi, Saeed

AU - Borbath, Ivan

AU - Goyal, Lipika

AU - Cohn, Allen

AU - Lamarca, Angela

AU - Oh, Do Youn

AU - MacArulla, Teresa

AU - T Shroff, Rachna

AU - Howland, Michael

AU - Li, Ai

AU - Cho, Terry

AU - Pande, Amit

AU - Javle, Milind

PY - 2020/10

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N2 - Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients.

AB - Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients.

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KW - fibroblast growth factor receptor inhibitor

KW - infigratinib

KW - targeted therapy

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Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF 301 trial

Abstract

Keywords

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