other material
confidence high
sentiment positive
materiality 0.75
Cogent reports positive Phase 2 bezuclastinib data in systemic mastocytosis at ASH 2023
Cogent Biosciences, Inc.
- SUMMIT Part 1a: 100% of bezuclastinib patients achieved ≥50% reduction in serum tryptase vs 0% on placebo; 100% achieved ≥50% reduction in KIT D816V VAF.
- APEX Part 1: 52% ORR per mIWG-MRT-ECNM criteria (56% in TKI-naïve); 75% PPR ORR (86% in TKI-naïve).
- Safety: no related cognitive impairment or bleeding events; most AEs low grade and reversible.
- SUMMIT Part 2 (registration-directed) to start H1 2024; APEX Part 2 (~65 patients) enrollment on track for end of 2024.
- 100% of bezuclastinib patients in SUMMIT with measurable baseline mast cell aggregates achieved ≥50% reduction in bone marrow mast cell burden vs 14% placebo.