Celcuity presented updated Phase 3 VIKTORIA-1 results for gedatolisib in PIK3CA wild-type HR+/HER2- advanced breast cancer at SABCS 2025 on December 11, featuring subgroup efficacy and safety data.14
Gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) showed median PFS of 9.3 months (HR 0.24) vs 2.0 months for fulvestrant; doublet showed 7.4 months (HR 0.33).23
Subgroup data:
PFS 12.4 months (triplet, HR 0.17) and 10.0 months (doublet, HR 0.19) for prior therapy >18 months; 16.6 months (triplet, HR 0.14) in US/Canada/Western Europe/Asia Pacific patients.4
Low treatment discontinuation:
2.3% triplet, 3.1% doublet; median time to definitive deterioration 23.7 months (triplet, HR 0.39).24
PIK3CA mutant cohort fully enrolled, topline data expected Q1/Q2 2026; NDA submitted November 17, 2025.12
No specific SABCS 2025 details found on Relay PI3K inhibitors' consistent performance in provided results; prior ESMO data noted positive PI3K inhibitor outcomes in breast cancer.39
SABCS 2025 held December 9-12, 2025; Celcuity abstract in Rapid Fire 7 (RF7-04).14
Sources:
1. https://www.stocktitan.net/news/CELC/celcuity-to-present-updated-data-from-the-pik3ca-wild-type-cohort-of-evg2hf8hfwvc.html
2. https://www.biospace.com/press-releases/celcuity-inc-reports-third-quarter-2025-financial-results-and-provides-corporate-update
3. https://www.clinicaltrialsarena.com/analyst-comment/esmo-2025-celcuity-positive-results-pi3k-inhibitor-breast-cancer/
4. https://www.globenewswire.com/news-release/2025/12/11/3204248/0/en/Celcuity-Presents-Updated-Results-from-the-PIK3CA-Wild-Type-Cohort-of-the-Phase-3-VIKTORIA-1-Trial-at-the-2025-San-Antonio-Breast-Cancer-Symposium.html
9. https://www.oncologypipeline.com/apexonco/esmo-2025-celcuity-fights-share-breast-cancer-market