Incyte has called it quits on a Phase III study for its oral PI3K inhibitor, parsaclisib, a year after withdrawing its accelerated approval pitch for a different indication.
March 3 (Reuters) - Drugmaker Incyte Corp (INCY.O) said on Friday it was stopping its late-stage trial of an experimental cancer drug after an interim analysis indicated the drug was unlikely to meet the main goal of the study, dragging its shares 2% lower in after-market trade.
Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced new data from two of its LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib) trials evaluating monotherapy and combination strategies using ruxolitinib (Jakafi®) with parsaclisib, its investigational phosphatidylinositol 3-kinase delta (PI3K?) inhibitor, and INCB00928 (zilurgisertib), its activin receptor-like kinase (ALK2) inhibitor, in patients with myelofibrosis (MF). These Phase 2 and Phase 1/2 trials (Abstract #236 and Abstract #1714, respectively) were presented at the 64th American Society of Hematology (ASH) Annual Meeting, held December 10-13, 2022, in New Orleans and virtually1,2.
The follicular lymphoma market is thinning out fast. Days after Gilead Sciences pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies.
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K?), and MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement with Merus.
Innovent Announces Pivotal Phase 2 Results for Parsaclisib (PI3K? inhibitor) Presented at ASH 2021 Show Durable nResponses in Patients with Relapsed or Refractory Follicular Lymphoma
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K?), for the treatment of patients with relapsed or refractory follicular lymphoma (FL) (CITADEL-203), marginal zone lymphoma (MZL) (CITADEL-204) and mantle cell lymphoma (MCL) (CITADEL-205). These data were accepted as oral presentations at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and virtually.
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K?), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).