other material
confidence high
sentiment positive
materiality 0.85
Cogent Biosciences reports positive Phase 2 bezuclastinib data in AdvSM and NonAdvSM at ASH 2024
Cogent Biosciences, Inc.
- APEX (AdvSM): 52% ORR per mIWG-MRT-ECNM; 61% in TKI-naïve; 83% at 100 mg BID. Median PFS not reached; 24-mo PFS rate 82%.
- 100% PPR ORR at 100 mg BID; 94% of patients had >=50% tryptase reduction; 93% had >=50% KIT D816V VAF reduction.
- SUMMIT (NonAdvSM): 56% mean TSS improvement; 76% of patients had >50% MS2D2 reduction; 49% mean MC-QoL improvement at 24 wks.
- 95% of patients with baseline tryptase >=20 ng/mL achieved <20 ng/mL by week 24; 84% with baseline >11.4 ng/mL achieved <11.4.
- SUMMIT Part 2 enrollment complete (179 patients); top-line expected July 2025. APEX Part 2 enrollment completion Q1 2025; top-line mid-2025.