VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer - PubMed
4 days ago
- #PI3K inhibitor
- #breast cancer
- #clinical trial
- The VIKTORIA-1 trial evaluated gedatolisib-based therapy in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer.
- Gedatolisib targets all four class I PI3K isoforms and mTORC1/mTORC2 to block the PI3K/AKT/mTOR pathway.
- Patients were randomized to receive gedatolisib triplet (gedatolisib, palbociclib, fulvestrant), gedatolisib doublet (gedatolisib, fulvestrant), or fulvestrant monotherapy.
- Median progression-free survival was 9.3 months (triplet), 7.4 months (doublet), and 2.0 months (fulvestrant monotherapy).
- Grade ≥3 treatment-related adverse events included neutropenia, stomatitis, rash, hyperglycemia, and diarrhea.
- Gedatolisib-based therapy significantly reduced the risk of disease progression or death compared to fulvestrant alone.