Incyte Reports Results of Itacitinib in GRAVITAS-301 P-III Study for Patients with Treatment-Naive Acute Graft-Versus-Host Disease

Shots:

• The GRAVITAS-301 (NCT03139604) P-III study involves assessing of Itacitinib + corticosteroid vs PBO + corticosteroid for 1L patients with acute GVHD
• The P-III study did not meet its 1EP of improving ORR @28 day (74.0% vs 66.4%), with no difference in NRM @6 mos. and showed a consistent safety profile. Additionally, the company is evaluating ruxolitinib in REACH trial which should positive results in steroid-refractory acute GVHD
• Itacitinib (INCB039110) is a selective JAK1 inhibitor targeted for first-line treatment of patients with acute and chronic GVHD. Incyte holds the global development and commercialization rights (ex-China) for itacitinib while Innovent holds the rights for China. In 2018, Innate in-licensed Lumoxiti from AstraZeneca, post-approval in the US in Sep 2019

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