- Cogent Biosciences Inc COGT announced positive updated clinical data from its ongoing Phase 2 APEX trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM).
- Bezuclastinib was generally well-tolerated at all doses. The majority of adverse events were Grade 1/2 and occurred in no more than one patient.
- 89% overall response rate (ORR) in TKI-therapy naïve patients, 73% ORR in all evaluable patients with a 27-week median follow-up.
- Additionally, results of key markers of clinical activity were reported from 16 patients.
- 14/16 patients achieved ≥ 50% reduction in serum tryptase levels by central assessment.
- 13/13 patients with ≥2 cycles of treatment achieved ≥50% reduction in bone marrow mast cells.
- In addition, Cogent continues to enroll patients in SUMMIT Phase 2 trial with bezuclastinib for patients with non-advanced systemic mastocytosis and the PEAK Phase 3 trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST).
- Cogent plans to present initial clinical efficacy results from the PEAK lead-in study during 1H of 2023 and SUMMIT in 2H of 2023.
- Price Action: COGT shares are up 13.9% at $12.64 on the last check Monday.
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