Cogent Biosciences reports 89% ORR in TKI-naive AdvSM patients from Phase 2 APEX trial

Cogent Biosciences, Inc.

89% ORR in TKI-naïve patients; 73% ORR in all evaluable patients (median 27-week follow-up).
First confirmed CR at 20 weeks; 77% with ≥2 cycles had complete clearance of bone marrow mast cell aggregates.
No related cognitive effects or intracranial bleeding; favorable safety profile with mostly Grade 1/2 events.
Median age 69 years; subtypes: ASM (3), SM-AHN (12), MCL (1); 3 had prior avapritinib/midostaurin.
Plans to present initial PEAK lead-in data H1 2023 and SUMMIT data H2 2023.

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