Positive data from pivotal AGAVE-201 trial of Niktimvo published

US companies Incyte (Nasdaq: INCY) and Syndax Pharmaceuticals (Nasdaq: SNDX) today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, in adult and pediatric patients with recurrent/refractory active chronic graft-versus-host disease (GVHD) who had received at least two prior lines of systemic therapy.

The data are were published in The New England Journal of Medicine. The publication, entitled "Axatilimab in Recurrent or Refractory Chronic Graft-Versus-Host Disease" can be found online here.

“Niktimvo is the first US Food and Drug Administration (FDA) approved treatment that targets the disease-modifying macrophages involved in both the fibrotic and inflammatory processes driving chronic GVHD," said Dr Pablo Cagnoni, president and head of R&D at Incyte. "Following the launch of this new medicine, clinicians will be able to offer patients an agent that targets a distinct pathway and has demonstrated broad and durable responses in patients with chronic GVHD who progressed after at least two prior lines of therapy," he noted.