Incyte's Jakafi fails label expansion trial

In a 110-patient, randomized, double-blind Phase 3 clinical trial comparing Incyte Corp.'s (INCY +2.2%) Jakafi (ruxolitinib) to hydroxyurea (HU) as a treatment for polycythemia vera (PV), the JAK inhibitor failed to achieve its primary endpoint of a statistically significant proportion of patients with a 50% reduction in a defined cluster of symptoms (e.g. fatigue, itching, muscle aches) versus baseline at Week 16. Top-line results showed a 43.4% symptom response rate in the ruxolitinib cohort and a 29.6% symptom response rate in the hydroxyurea group.

The symptom control rate for the HU arm was 5x - 6x greater that the rate observed in an earlier trial that Incyte used as the basis for its sNDA submission. The FDA designated Jakafi Fast Track for PV based on the data from that trial.

The company plans to analyze the data in depth. It intends to present the results at a future scientific meeting.

INCY shares are down 6% AH on modest volume.

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