other material
confidence high
sentiment positive
materiality 0.80
Syndax/Incyte axatilimab hits primary endpoint in cGVHD trial; 74% ORR at 0.3 mg/kg dose
Syndax Pharmaceuticals Inc
- AGAVE-201 met primary endpoint: ORR 74% (0.3 mg/kg Q2W), 67% (1.0 mg/kg), 50% (3.0 mg/kg Q4W).
- At 0.3 mg/kg dose, 60% of responders maintained response at 12 months; median DOR not reached.
- Patients had median 4 prior therapies; 54% with ≥4 organs involved; 45% lung involvement.
- Syndax and Incyte intend to file BLA with FDA by year-end 2023.
- Safety consistent with CSF-1R inhibition; 38% SAEs in 0.3 mg/kg group; 6.3% discontinued.