Incyte Corp. and Novartis AG's Jakafi met the main goal of a late-stage study after it improved the response rate in patients with a type of stem cell transplant complication.
Wilmington, Del.-based Incyte said Jakafi, or ruxolitinib, was being evaluated against best available therapy in a phase 3 trial dubbed Reach2 in patients with acute graft versus host disease, or aGVHD, who do not respond to or are resistant to steroid therapy.
GVHD is a condition that occurs after a stem cell transplant from a donor causes an immune response, resulting in donated cells attacking the transplant recipient's organs.
Jakafi is already approved to treat aGVHD, myelofibrosis and polycythemia vera.
Incyte said that after a month of treatment, Jakafi improved overall response rate — a measure of partial or complete response — in patients who received the treatment compared to those on the best available therapy.
Further analysis of the safety and efficacy data was ongoing, Incyte said in an Oct. 16 press release.
Switzerland-based Novartis — which markets Jakafi outside the U.S. — expects to begin discussions with regulatory authorities outside the U.S. in 2020, and submit the results at an upcoming scientific meeting. Incyte holds rights to the drug in the U.S.
The two companies are also evaluating ruxolitinib in patients with chronic GVHD who do not respond to steroid therapy in another trial called Reach3, results from which are expected in 2020.
Ruxolitinib cream formulation has also been shown to improve repigmentation in patients with a type of skin disease called vitiligo in a mid-stage study.