- Incyte Corporation INCY has announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM). The study is jointly sponsored by Incyte and Novartis AG NVS.
- The publication includes data showing Jakafi (ruxolitinib) significantly improved overall response rate at Week 24 (49.7% vs. 25.6%) with a higher best overall response rate (76.4% vs. 60.4%) vs. best available therapy (BAT) in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD).
- In addition, a new subgroup analysis included in the publication found that patients on ruxolitinib had better outcomes regardless of the individual organs affected at baseline.
- No new safety signals were observed in REACH3, and adverse events attributable to treatment were consistent with the known safety profile of ruxolitinib.
- Mortality rates were similar across treatment arms (18.8% in the ruxolitinib arm vs. 16.5% in the BAT arm).
- Deaths reported primarily due to chronic GVHD complications or treatment were higher in the ruxolitinib vs. BAT arms (13.3% vs. 7.9%, respectively).
- The U.S. application is currently under review, with a target action date of September 22, 2021.
- Price Action: INCY shares closed at $79.87 on Wednesday.
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