Celcuity posts VIKTORIA-1 Study 2 phase 3 gedatolisib breast cancer presentation

Celcuity Inc.

Celcuity Inc.

CELC

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  • Celcuity published a Phase 3 VIKTORIA-1 Study 2 presentation on gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2-/PIK3CA-mutant advanced breast cancer.
  • Gedatolisib combinations doubled median progression-free survival versus alpelisib with fulvestrant, the standard-of-care comparator.
  • Discontinuations due to adverse events were under 4% for the gedatolisib regimens, pointing to improved tolerability versus PI3Kα inhibition.
  • The study was described as the first Phase 3 evidence that multi-target PI3K/AKT/mTOR pathway inhibition improves outcomes versus single-target pathway blockade.
  • Overall survival is a key secondary endpoint, with final analysis expected in the second half of 2027.


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