Syndax-Incyte Partnered Chronic Graft-Versus-Host Disease Achieves Primary Endpoint In Pivotal Trial, FDA Submission Planned By 2023 End

Syndax Pharmaceuticals SNDX and Incyte Corporation INCY announced topline data from the AGAVE-201 trial of axatilimab, in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy. 

The trial achieved its primary endpoint across all cohorts, with patients treated with axatilimab at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks, and 3.0 mg/kg every four weeks demonstrating overall response rates (ORR) within the first six months of treatment of 74%, 67%, and 50%, respectively.

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Responses were achieved across key patient subgroups, including those with prior exposure to ruxolitinib, belumosudil and/or ibrutinib. 

Based on these results and pending agreement from the FDA, Syndax and Incyte intend to submit a Biologics License Application (BLA) to the FDA by year-end 2023.

The AGAVE-201 study enrolled 241 patients across 121 sites in 16 countries. 

Among responders treated with 0.3 mg/kg of axatilimab, 60% of patients maintained a response at 12 months. The median duration of response in this population has not been reached. 

Additionally, in the 0.3 mg/kg group, 55% of patients experienced a clinically meaningful improvement in symptoms, as measured by at least a seven-point decrease in the modified Lee chronic GVHD Symptom Scale score. 

Price Action: SNDX shares are down 1.03% at $21.04, and INCY stock is down 0.80% at $63.64 on the last check Monday.