Incyte halts ph3 myelofibrosis study, unmet endpoint
Incyte has announced that it is discontinuing its phase 3 LIMBER-304 trial for bone marrow cancer drug combination, following a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC), the results indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.
Incyte has made it clear that the recommendation to stop the study was not due to safety, but its shares subsequently dropped 2% in after-market trade.
Incyte specialises in discovering and developing therapies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-hot disease (GVHD). The overall LIMBER clinical trial programme is designed to evaluate multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs and GVHD, including ruxolitinib-based combinations with BET and ALK2, new therapeutic options including axatilimab, as well as novel targets such as mutant CALR.
A randomised, double-blind study evaluating the efficacy and safety of parasclisib plus the drug ruxolitinib (Jakafi) versus placebo plus ruxolitinib in adults 18 years and above living with myelofibrosis (MF) who have an inadequate response to ruxolitinib, the primary endpoint of LIMBER-304 (NCT04551053) had been the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography.
The trial’s 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.
Further review of the data is continuing to be conducted and Incyte will inform investigators of those results and work with them to appropriately conclude the study “in a manner consistent with the best interests of each patient”. This additional data will be submitted for presentation at an upcoming scientific meeting.
In March last year, Incyte withdrew its FDA application for accelerated approval of its PI3K candidate parsaclisib for three types of non-Hodgkin lymphoma (NHL) – FL, marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) – based on phase 2 data discussions with the FDA.
