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Itacitinib Misses Primary Endpoint in Frontline Acute GVHD

Gina Columbus
Published: Monday, Jan 06, 2020

Steven Stein from Incyte

Steven Stein, MD

The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate (ORR) at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease (aGVHD), missing the primary endpoint of the phase III GRAVITAS-301 trial (NCT03139604).1



  1. Incyte announces results of phase 3 study of itacitinib in patients with treatment-naïve acute graft-versus-host disease [news release]. Wilmington, DE: Incyte Corporation; January 2, 2020. Accessed January 2, 2020.
  2. Pratta MA, Liu H, Owens S, et al. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft versus host disease. Blood. 2019;134(suppl_1):3279. doi: 10.1182/blood-2019-124069.

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