Press release
CORRECTING and REPLACING Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma
Data presented at ESMO support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pemigatinib before
About this update from Incyte Corporation
[{"type":"text","content":"\n\nData presented at ESMO support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pemigatinib before the end of 2019 \n\n\nInvestor conference call and webcast scheduled for today, September 27, at 5:00 p.m. CEST (11:00 a.m. EDT)\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nSixth paragraph, fourth sentence of release should read: Serous retinal detachment was observed in 4 percent of patients (Grade ≥3, 1 percent) with none of the cases resulting in clinical sequelae. (instead of Serious retinal detachment was observed in 4 percent of patients (Grade ≥3, 1 percent) with none of the cases resulting in clinical sequelae.)\n\n\nThe corrected release reads: \n\n\nINCYTE ANNOUNCES POSITIVE UPDATED RESULTS FROM PHASE 2 TRIAL OF PEMIGATINIB IN PATIENTS WITH PREVIOUSLY TREATED, ADVANCED CHOLANGIOCARCINOMA\n\n\n\nData presented at ESMO support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pemigatinib before the end of 2019 \n\n\nInvestor conference call and webcast scheduled for today, September 27, at 5:00 p.m. CEST (11:00 a.m. EDT)\n\n\n\nIncyte (Nasdaq:INCY) announces updated results, including the final result for the primary endpoint, from its Phase 2 FIGHT-202 trial evaluating pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. In patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median progression free survival (PFS) of 6.9 months (secondary endpoint) with a median follow-up of 15 months. Pemigatinib was generally well tolerated.\n\n\nThese results are being presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain during a late-breaking oral session today, September 27, from 3:00 p.m. CEST to 3:15 p.m. CEST (9:00 a.m. EDT to 9:15 a.m. EDT) in Madrid Auditorium (Hall 2); Abstract #LBA40.\n\n\n“We are excited to share updated data for pemigatinib, which may provide a promising and targeted treatment approach for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements,” said Peter Langmuir, M.D., Group Vice President, T...