Updated data from a Phase 2 clinical trial, FLIGHT-202, evaluating Incyte’s (NASDAQ:INCY) pemigatinib in patients with advanced/metastatic cholangiocarcinoma (bile duct cancer) showed a treatment benefit. The results are being presented at ESMO in Barcelona.
The overall response rate (ORR) in patients with FGFR2 fusions or rearrangements, a subpopulation of bile duct cancer patients with a poor prognosis, was 36% (n=38/107), including three complete responders and 35 partial responders. 50 patients experienced stable cancer implying a disease control rate of 82% (n=88/107). Median duration of response was 7.5 months and median progression-free survival was 6.9 months. Preliminary median overall survival was 21.1 months (data still maturing).
On the safety front, the most common serious/life-threatening treatment-emergent adverse event was hypophosphatemia (12%) although none were considered clinically significant and there were no dose reductions or discontinuations. Serious retinal detachment was observed in 4% of patients with none resulting in clinically significant consequences.
The company plans to file a U.S. marketing application before year-end.
Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor.
Management will host a conference call today at 11:00 am ET to discuss the data.
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