Cogent Biosciences Touts Positive Data From Bezuclastinib Study In Mastocytosis Patients

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  • 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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