Abstract
FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2385-2399 |
| Number of pages | 15 |
| Journal | Future Oncology |
| Volume | 16 |
| Issue number | 30 |
| DOIs | |
| State | Published - Oct 2020 |
Keywords
- FGFR
- INCB054828
- cholangiocarcinoma
- pemigatinib
ASJC Scopus subject areas
- Oncology
- Cancer Research
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In: Future Oncology, Vol. 16, No. 30, 10.2020, p. 2385-2399.
Research output: Contribution to journal › Review article › peer-review
}
TY - JOUR
T1 - FIGHT-302
T2 - First-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements
AU - Bekaii-Saab, Tanios S.
AU - Valle, Juan W.
AU - Van Cutsem, Eric
AU - Rimassa, Lorenza
AU - Furuse, Junji
AU - Ioka, Tatsuya
AU - Melisi, Davide
AU - MacArulla, Teresa
AU - Bridgewater, John
AU - Wasan, Harpreet
AU - Borad, Mitesh J.
AU - Abou-Alfa, Ghassan K.
AU - Jiang, Ping
AU - Lihou, Christine F.
AU - Zhen, Huiling
AU - Asatiani, Ekaterine
AU - Féliz, Luis
AU - Vogel, Arndt
N1 - Funding Information: Medical writing assistance was provided by Sneha DSilva, MD, CMPP (Envision Pharma Group, PA, USA), and funded by Incyte Corporation. Funding Information: TS Bekaii-Saab received research funding (to their institution) from Abgenomics, Amgen, Array Biopharma, Bayer, Bristol-Myers Squibb, Boston Biomedical, Celgene, Clovis, Genentech, Incyte, Ipsen, Lilly, Merck and Seattle Genetics; consulting fees (to their institution) from Array Biopharma, Bayer, Genentech, Incyte, Ipsen and Merck; and is an Independent Data Monitoring Committee (IDMC)/Data Safety Monitoring Board (DSMB) member at 1Globe, AstraZeneca, Exelixis, Lilly and PanCan. JW Valle received honoraria from Ipsen; is a consultant for and/or is on the advisory board of Agios, AstraZeneca, Debiopharm, Delcath Systems, Genoscience Pharma, Imaging Equipment Limited, Incyte, Ipsen, Keocyt, Merck, Mundipharma EDO, Novartis, NuCana, Pfizer, PCI Biotech, Pieris Pharmaceuticals, QED Therapeutics, Servier and Wren Laboratories; served on a speaker’s bureau for Imaging Equipment Limited, Ipsen, Novartis and NuCana; received travel grant from Celgene, NuCana and Pfizer. E Van Cutsem is a consultant for and/or is on the advisory board of Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Incyte, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche and Servier; received research grant/funding from Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche and Servier. L Rimassa is a consultant for and/or is on the advisory board of Amgen, ArQule, Basilea, Baxter, Bayer, Celgene, Eisai, Exelixis, Hengrui, Incyte, Ipsen, Italfarmaco, Lilly, MSD, Roche, Sanofi and Sirtex Medical; received honoraria (lecture fees) from AbbVie, Amgen, AstraZeneca, Gilead, Ipsen, Lilly, Roche and Sanofi; received travel expenses from ArQule and Ipsen; institutional research grant/funding from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Incyte, Ipsen, Lilly and MSD. J Furuse received honoraria from and is a consultant for and/or is on the advisory board of AbbVie, Astellas Pharma, AstraZeneca, Bayer Yakuhin, Chugai Pharma, Daiichi Sankyo, EA Pharma, Eisai, Eli Lilly Japan, Fujifilm, Fujifilm Toyama Chemical, J-Pharma, Kyowa Hakko Kirin Otsuka, Merck Serono, Mochida Pharmaceutical, MSD, Nihon Servier, Nippon Kayaku, Nobelpharma, Novartis, Ono Pharmaceutical, Pfizer, Sanofi, Sawai Pharmaceutical, Shionogi, Shire, Sumitomo Dainippon, Taiho Pharmaceutical, Takara Bio, Takeda, Teijin Pharma and Yakult Honsha; received research funding from Astellas Pharma, AstraZeneca, Bayer Yakuhin, Chugai Pharma, Daiichi Sankyo, Eli Lilly Japan, Eisai, Kyowa Hakko Kirin, Mochida Pharmaceutical, MSD, NanoCarrier, Ono Pharmaceutical, Pfizer, Sanofi, Sumitomo Dainippon, Taiho Pharmaceutical, Takeda and Yakult Honsha. T Ioka is a consultant for and/or is on the advisory board of Incyte, Otsuka and Taiho Pharmaceutical; received research grant/funding from Astellas, AstraZeneca, Eisai, Incyte, Nihon Zouki, Otsuka, Servier, Shire, Taiho Pharmaceutical and Takara Bio. D Melisi received research funding from Celgene, Evotec, Incyte and Shire; is a consultant for Baxter, Eli Lilly, Evotec, Incyte and Shire. T Macarulla is on the advisory board of Amgen, AstraZeneca, Celgene, Eisai, Incyte, Sanofi and Servier; received research funding from AstraZeneca, BeiGene and Celgene. J Bridgewater is a consultant for Bayer, Bristol-Myers Squibb, Incyte, Merck Serono and Roche; received travel support from Bristol-Myers Squibb and Merck Sharpe Dohme. H Wasan is on the advisory board of Array BioPharma, Celgene, ERYTECH Pharma, Incyte, Pierre Fabre, Roche/Genentech/ FM AG, Servier, Shire and Sirtex Medical; is a consultant for NICE and OncoSil Medical; is an expert for Bayer (uncompensated); and received honoraria, serves on the speaker’s bureau for, and received travel expenses from BTG/Biocompatibles, Bristol-Myers Squibb and Merck KGaA; received research funding from Merck Serono, MSD, Pfizer and Sirtex. MJ Borad received research grant/funding from Adaptimmune, Agios, ARIAD, Basilea, Bioline, Boston Biomed, Celgene, Dicerna, EMD Merck Serono, Halozyme Therapeutics, Incyte, Isis Pharmaceuticals, MedImmune, Mirna Therapeutics, Novartis, Pieris, PUMA, QED Therapeutics, Redhill Biopharma, Senhwa Biosciences, SillaJen, Sun Biopharma, Taiho Pharmaceutical and Toray; received honoraria from ADC Therapeutics, Exelixis, G1 Therapeutics, Immunovative Therapies, Inspyr Therapeutics, Lynx Group and Western Oncolytics; is a shareholder/stockholder at AVEO, Intercept and OncBioMune Pharmaceuticals; received travel/accommodation support from AstraZeneca. GK Abou-Alfa received research funding from ActaBiologica, Agios, Array, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Casi, Celgene, Exelixis, Genentech, Halozyme, Incyte, Mab Vax Therapeutics, Polaris Puma, QED Therapeutics and Roche; and is a consultant for Agios, AstraZeneca, Autem, Bayer, BeiGene, Berry Genomics, Bioline, Celgene, CytomX, Debiopharm, Eisai, Eli Lilly, Flatiron, Genentech, Genoscience, Gilead, Incyte, Ipsen, LAM, Loxo Oncology, Merck, MINA Pharmaceuticals, QED Therapeutics, Redhill Biopharma, Roche, Silenseed, SillaJen, Sobi, Targovax, Therabionics, twoXAR and Yiviva. P Jiang, CF Lihou, H Zhen, E Asatiani and L Féliz are employees and stockholders of Incyte Corporation. A Vogel is a consultant for and/or is on the advisory board of As-traZeneca, Bayer, Delcath, Incyte, Lilly, Medac, Roche and Shire; serves on the speaker’s bureau for and/or received fees for expert testimony from AstraZeneca, Bayer, Delcath, Incyte, Lilly, Medac, Roche and Shire; and received travel/accommodation expenses from AstraZeneca, Bayer, Delcath, Incyte, Lilly, Medac, Roche and Shire. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2020 Tanios Bekaii-Saab.
PY - 2020/10
Y1 - 2020/10
N2 - FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life.
AB - FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life.
KW - FGFR
KW - INCB054828
KW - cholangiocarcinoma
KW - pemigatinib
UR - http://www.scopus.com/inward/record.url?scp=85094684730&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85094684730&partnerID=8YFLogxK
U2 - 10.2217/fon-2020-0429
DO - 10.2217/fon-2020-0429
M3 - Review article
C2 - 32677452
AN - SCOPUS:85094684730
SN - 1479-6694
VL - 16
SP - 2385
EP - 2399
JO - Future Oncology
JF - Future Oncology
IS - 30
ER -