Incyte Discontinues Phase 3 Study in Myelofibrosis

Rare Daily Staff

Incyte said that it will discontinue the late-stage trial evaluating the efficacy and safety of parsaclisib plus ruxolitinib in adults with myelofibrosis because it is unlikely to meet the primary endpoint.

The decision follows a pre-planned interim analysis conducted by an independent data monitoring committee and 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 patients living with myelofibrosis who have an inadequate response to ruxolitinib monotherapy.

While further review of the data is conducted, Incyte says it will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the interest of each patient. Data from this study will be submitted for presentation at an upcoming scientific meeting.

Myelofibrosis (MF) is a rare, chronic blood cancer that is part of a group of diseases known as myeloproliferative neoplasms (MPNs). In MF, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, and symptoms such as fatigue, itching, and night sweats, which can impact a patient’s quality of life. About 16,000 to 18,500 people in the United States are living with MF.

The primary endpoint of LIMBER-304 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 percent 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.