Celcuity posts Phase 3 VIKTORIA-1 gedatolisib data presentation in HR+/HER2- PIK3CA-mutant breast cancer

Celcuity Inc.

Celcuity Inc.

CELC

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  • Celcuity published a presentation detailing Phase 3 VIKTORIA-1 results for gedatolisib in HR+/HER2-/PIK3CA-mutant advanced breast cancer.
  • The gedatolisib regimen with palbociclib, fulvestrant met the primary endpoint, improving BICR-assessed PFS versus alpelisib with fulvestrant.
  • Median PFS was 11.1 months versus 5.6 months; adjusted hazard ratio 0.5; P<0.0001.
  • A gedatolisib-fulvestrant doublet also improved PFS, 11.3 months versus 5.6 months; hazard ratio 0.51; P<0.0013.
  • Interim overall survival analysis showed hazard ratio 0.76; P<0.0908, missing the prespecified boundary for statistical significance.


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