Press release
Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis
Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study WILMINGTON,
About this update from Incyte Corporation
[{"type":"text","content":"\n\nIndependent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\n\nIncyte (Nasdaq:INCY) today announced that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. The recommendation to stop the study was not due to safety. LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus ruxolitinib (Jakafi®) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.\n\nWhile further review of the data is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient. Data from this study will be submitted for presentation at an upcoming scientific meeting.\n\nThe primary endpoint of LIMBER-304 (NCT04551053) was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography. Secondary endpoints included the proportion of patients who have a targeted reduction in Total Symptom Score (TSS), change in TSS, time to the first ≥50% reduction in TSS, overall survival, number of treatment emergent adverse events, time of onset of targeted reduction in spleen volume and duration of maintenance of targeted reduction in spleen volume.\n\nAbout LIMBER\n\nIncyte is a leader in the discovery and development of therapies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD). The LIMBER clinical trial program is designed to evaluate multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD. These include ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab and novel targets such as mutant CALR.\n\nAbout Incyte\n\nIncyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, deve...