Celcuity Inc. said on Wednesday it submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration seeking to expand the approved use of its breast cancer therapy REVTORPYK.
The Minneapolis-based biotech is targeting patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer harboring a PIK3CA mutation who have progressed on at least one prior endocrine therapy. The filing follows the drug’s accelerated approval in July for use with fulvestrant, with or without palbociclib, in patients without a PIK3CA mutation.
The application is supported by data from the Phase 3 VIKTORIA-1 trial, which enrolled 701 subjects regardless of PIK3CA status. Among the 350 patients with confirmed PIK3CA mutations, the gedatolisib-based triplet regimen reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant, yielding a median progression-free survival of 11.1 months versus 5.6 months. The objective response rate reached 49%, with a median duration of response of 15.7 months.
A separate cohort testing the gedatolisib doublet showed a 49% reduction in progression risk, with median progression-free survival of 11.3 months versus 5.6 months and an objective response rate of 36%. The median duration of response in this arm was 24.2 months.
REVTORPYK is a dual inhibitor of class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2. Celcuity is also evaluating the drug as a first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer and in second-line metastatic castration-resistant prostate cancer.
