BRIEF—Incyte braced for damage from myelofibrosis trial failure

6 March 2023

US biopharma company Incyte announced late Friday that it will discontinue its Phase III LIMBER-304 trial, sending its share price 2% lower early in Monday’s trading.

The decision is based on the results of a pre-planned interim analysis conducted by an independent data monitoring committee  indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.

Incyte has stressed that 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 Jakafi (ruxolitinib), versus placebo plus ruxolitinib, in adult patients living with myelofibrosis who have an inadequate response to ruxolitinib monotherapy.

The primary endpoint of the trial was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography.

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