ASH 2023 – Incyte hopes to add axatilimab to the arsenal

Incyte already has one graft-versus-host disease drug in the form of its JAK inhibitor Jakafi, and it hopes soon to have another, after positive pivotal data were presented at ASH today with the Syndax-originated anti-CSF1R antibody axatilimab. The uncontrolled Agave-201 trial tested three doses of axatilimab in third-line or later chronic GvHD: 0.3mg or 1.0mg every two weeks and 3.0mg every four weeks. The primary endpoint was overall response rate, and the 0.3mg dose performed best, with an ORR of 74%; the company previously said that anything over 50% would be meaningful. Presenting the data Dr Daniel Wolff, of University Hospital Regensburg, said the inverse dose response might be explained by the fact that higher doses lead to prolonged depletion of monocytes and macrophages. The 0.3mg dose also had the most favourable side-effect profile, although there was one fatal adverse event of severe lung disease. This seems the most likely dose to be taken forward, with a regulatory filing planned by the end of the year. Wolff added that there was no reason axatilimab shouldn’t work in earlier therapy lines; Incyte is already planning a phase 1/2 combo study with Jakafi in first and second-line GvHD.

The GvHD landscape

Source: OncologyPipeline.