Update on interim analysis of phase III LIMBER-304 study of parsaclisib + ruxolitinib in patients with myelofibrosis.- Incyte
Incyte announced that it will discontinue the Phase III 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 greater than 18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.
While 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..
The 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 greater than 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.
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