Front-line setting next for axatilimab

The Syndax-originated anti-CSF1R antibody axatilimab, approved by the FDA yesterday as Niktimvo, marks just one stage of Incyte’s push to dominate the treatment of graft-versus-host disease. The green light has come in the third-line or later setting, but plans are already afoot to move the drug higher up the paradigm: a phase 2 combo with Incyte’s approved GvHD drug Jakafi will explore the front-line setting, and is set to begin next month. Its clinicaltrials.gov entry reveals ORR versus either Jakafi or steroids alone as the primary endpoint. Meanwhile, a phase 3 first-line GvHD study, testing Niktimvo plus steroids, is to begin by the year end, but has yet to appear on study registries. One curiosity from Niktimvo’s registrational Agave-201 trial was an inverse dose response, with 3mg/kg doing worse than 0.3mg/kg, and ultimately it was the latter that got approved. Evidently Incyte and Syndax expected a different regulatory outcome, filing a 50mg vial but now saying they would only launch Niktimvo in early 2025, after approval of two smaller vial sizes. For Syndax the bigger catalyst is the menin inhibitor revumenib, on whose approval the FDA is to decide by 26 December, after a three-month delay.

Selected Niktimvo trials in graft-versus-host disease

Source: OncologyPipeline.