Syndax and Incyte Report P-II Dose-Ranging Trial (AGAVE-201) of Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease
Shots:
- The P-II trial evaluating axatilimab in 241 adult & pediatric patients with recurrent or refractory active chronic GVHD across 121 sites in 16 countries
- The trial met its 1EPs across all cohorts i.e., patients treated with axatilimab at 0.3mg/kg, q2w, 1.0mg/kg, q2w & 3.0mg/kg, q2w doses showed ORR within the first 6mos. of treatment of 74%, 67% & 50% respectively, responses achieved across patient subgroups, incl. those with prior exposure to ruxolitinib, belumosudil and/or ibrutinib
- Both companies plan to submit a BLA to the US FDA at the year-end of 2023. At 0.3mg/kg dose, 60% maintained response at 12mos., the m-DoR (not reached), clinical improvement in symptoms (55%), SAEs in the overall population & the 0.3 mg/kg group (42.3% & 38%), treatment discontinuation due to AEs (15.5% & 6.3%), respectively
Ref: Syndax | Image: Incyte
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
