Incyte to discontinue phase 3 study of parsaclisib plus ruxolitinib for myelofibrosis
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A randomized phase 3 study of parsaclisib plus ruxolitinib for adults with myelofibrosis appeared unlikely to meet its primary endpoint and will be discontinued, according to the agents’ manufacturer.
The double-blind LIMBER-304 trial evaluated the safety and efficacy of parsaclisib (Incyte), a novel oral inhibitor of the phosphatidylinositol 3-kinase (PI3K) delta, in combination with the Janus kinase (JAK) inhibitor ruxolitinib (Jakafi, Incyte), specifically among patients who had an inadequate response to ruxolitinib monotherapy.
The proportion of patients who achieved targeted reduction in spleen volume, as measured by MRI or CT, from baseline to week 24 served as the primary endpoint. Secondary endpoints included the proportion of patients who had a targeted reduction in total symptom score, change in that score, time to the first 50% or greater reduction in the score, OS and number of treatment-emergent adverse events.
After conducting a preplanned interim analysis, the independent data safety monitoring committee advised that the study is unlikely to meet the primary endpoint in the intent-to-treat population, which prompted Incyte to discontinue the study, according to an Incyte press release. The recommendation to halt the study was not because of safety, the release stated.
Incyte will work with investigators to “conclude the study in a manner consistent with the best interest of each patient” and will submit study data for presentation at a future medical meeting, the release stated.
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