On October 9, 2018 Incyte (Nasdaq:INCY) reported that interim Phase 2 data on its investigational, selective FGFR1/2/3 inhibitor, pemigatinib (INCB54828), will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19-23, 2018 (Press release, Incyte, OCT 9, 2018, View Source [SID1234529818]).
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Data at ESMO (Free ESMO Whitepaper) 2018 will include poster presentations on the FIGHT-202 study of pemigatinib in patients with previously treated advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) with fibroblast growth factor (FGF)/FGFR genetic alterations, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (bladder cancer) harboring FGF/FGFR genetic alterations.
"We are pleased that data on pemigatinib – part of our targeted therapy portfolio – have been selected for presentation at this year’s ESMO (Free ESMO Whitepaper) Congress," stated Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing updated interim data from the ongoing FIGHT-202 trial of pemigatinib in patients with cholangiocarcinoma, which continue to support our plan for a 2019 NDA submission in this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which support recruitment into the continuous dosing cohort of this study."
Abstracts were made available today on the ESMO (Free ESMO Whitepaper) Congress website at View Source
Poster details:
Interim Results of FIGHT-202, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Previously Treated Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma (CCA) with/without Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Genetic Alterations (Abstract #756P, poster display session)
Sunday, 21 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub
Interim Results of FIGHT-201, a Phase 2, Open-Label, Multicenter Study of INCB054828 in Patients (pts) with Metastatic or Surgically Unresectable Urothelial Carcinoma (UC) Harboring Fibroblast Growth Factor (FGF)/FGF receptor (FGFR) Genetic Alterations (GA) (Abstract #900P, poster display session)
Monday, 22 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET) in Hall A3 – Poster Area Networking Hub
Full session details and data presentation listings for ESMO (Free ESMO Whitepaper) 2018 can be found at:
View Source
About FGFR and Pemigatinib (INCB54828)
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.
Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.