Celcuity Inc. · NASDAQ:CELC
Celcuity — ASCO 2026 Annual Meeting
19 slides from Celcuity's conference presentation, Jun 2, 2026
Slide 1: VIKTORIA-1 Study 2: Phase 3 gedatolisib + fulvestrant ± palbociclib
A randomized, open-label, Phase 3 study of gedatolisib + fulvestrant ± palbociclib vs. standard of care in HR+/HER2-/PIK3CA-mutant advanced breast cancer (VIKTORIA-1 Study 2) Sara A. Hurvitz, Giuseppe Curigliano, Fabrice Andre, Rachel M. Layman, Robert Wesolowski, Massimo Cristofanilli, Miguel Martí
Slide 2: Key Takeaway Points/Conclusions
Key Takeaway Points/Conclusions Gedatolisib + fulvestrant ± palbociclib Treatment discontinuation of doubled median PFS gedatolisib combinations compared with alpelisib + fulvestrant due to adverse events was low (<4%) in patients with HR+/HER2-/PIK3CA-MT ABC VIKTORIA-1 is the first Phase 3 study to
Slide 3: Background
3 Background • The PI3K/AKT/mTOR (PAM) pathway drives breast cancer growth and contributes to endocrine and CDK4/6i resistance in HR+/HER2- ABC • After CDK4/6i, patients with PIK3CA-mutant (MT) disease generally derive modest benefit from PI3Kα and AKT inhibitors and may experience significant toxic
Slide 4: VIKTORIA-1 Study Design
VIKTORIA-1 Study Design Arm D* HR+/HER2- 180 mg IV once weekly, Advanced Breast Cancer Gedatolisib 3 weeks on, 1 week off Primary Endpoint 125 mg daily, Palbociclib 21 days on, 7 days off Eligibility Criteria PFS (BICR) 500 mg; cycle 1, days 1 & 15, then • Pre- & postmenopausal women & men Fulvestra
Slide 5: Statistical Considerations
5 Statistical Considerations VIKTORIA-1 Study 2 • Primary endpoint – PFS by blinded independent central review (BICR) – One-sided overall alpha of 0.025 – 95% power to detect HR=0.56 for gedatolisib triplet vs. alpelisib + fulvestrant • Key secondary endpoints (hierarchical order) − OS for gedatolis
Slide 6: Patient Disposition
6 Patient Disposition VIKTORIA-1 Study 2 Randomized 3:1:3 (N=362) Arm D: Arm F: Arm E: Geda + Palbo + Fulvestrant Geda + Fulvestrant Alpelisib + Fulvestrant (n=155) (n=52) (n=155) Received allocated treatment, n=153 Received allocated treatment, n=52 Received allocated treatment, n=152 Discontinued
Slide 7: Baseline Demographics and Disease Characteristics
7 Baseline Demographics and Disease Characteristics VIKTORIA-1 Study 2 Arm D: Arm F: Arm E: Arm D: Arm F: Arm E: Characteristic Geda + Palbo/Fulv Geda + Fulv Alpe + Fulv Characteristic Geda + Palbo/Fulv Geda + Fulv Alpe + Fulv (n=155) (n=52) (n=155) (n=155) (n=52) (n=155) Age, yr, median (range) 60
Slide 8: Primary Endpoint: Progression-Free Survival (BICR)
Primary Endpoint: Progression-Free Survival (BICR) Gedatolisib Triplet vs. Alpelisib + Fulvestrant in VIKTORIA-1 Study 2 Arm D: Arm E: 100 Gedatolisib + Alpelisib + Palbo + Fulv Fulvestrant 90 (n=155) (n=155) 80 11.1 5.6 Median PFS, months (95% CI) Progression-free Survival (%) (9.0-16.7) (5.2-7.4)
Slide 9: PFS in Key Subgroups
PFS* in Key Subgroups Gedatolisib Triplet vs. Alpelisib + Fulvestrant, VIKTORIA-1 Study 2 Gedatolisib + Palbociclib + Fulvestrant Alpelisib + Fulvestrant Subgroup n/N n/N Hazard Ratio (95% CI) Age <65 years 53/107 65/97 0.47 (0.32-0.68) ≥65 years 15/48 34/58 0.46 (0.25-0.87) Menopause status Pre/per
Slide 10: Secondary Endpoint: Progression-Free Survival (BICR)
Secondary Endpoint: Progression-Free Survival (BICR) Gedatolisib Doublet vs. Alpelisib + Fulvestrant in VIKTORIA-1 Study 2 Arm F: Arm E: 100 Gedatolisib + Fulv Alpelisib + Fulv 90 (n=52) (n=155) 80 11.3 5.6 Median PFS, months (95% CI) Progression-free Survival (%) (9.1-22.1) (5.2-7.4) 70 Adjusted HR
Slide 11: PFS in Key Subgroups
PFS* in Key Subgroups Gedatolisib Doublet vs. Alpelisib + Fulvestrant, VIKTORIA-1 Study 2 Gedatolisib + Fulvestrant Alpelisib + Fulvestrant Subgroup n/N n/N Hazard Ratio (95% CI) Age <65 years 14/27 65/97 0.51 (0.28-0.88) ≥65 years 11/25 34/58 0.63 (0.32-1.31) Menopause status Pre/perimenopause 2/6
Slide 12: Key Secondary Endpoint: Overall Survival (Interim Analysis)
12 Key Secondary Endpoint: Overall Survival (Interim Analysis) VIKTORIA-1 Study 2 100 100 90 90 80 80 Overall Survival (%) Overall Survival (%) 70 70 Gedatolisib + Palbociclib + Fulvestrant Alpelisib + Fulvestrant 60 60 50 50 Gedatolisib + Fulvestrant 40 Alpelisib + Fulvestrant 40 30 Geda + Palbo +
Slide 13: Secondary Endpoint: Tumor Response by BICR
Secondary Endpoint: Tumor Response by BICR Response-Evaluable Population in VIKTORIA-1 Study 2 Arm D: Arm F: Arm E: Endpoint, n (%) Geda + Palbo + Fulv Gedatolisib + Fulv Alpelisib + Fulv (n=133) (n=42) (n=127) Best Overall Response Complete response 0 0 1 (0.8) Partial response 65 (48.9) 15 (35.7)
Slide 14: Duration of Response
Duration of Response VIKTORIA-1 Study 2 Arm D: Geda + Arm E: Arm F: Arm E: Palbo + Fulv Alpe + Fulv Geda + Fulv Alpe + Fulv 100 100 (n=65) (n=33) (n=15) (n=33) 90 15.7 7.5 90 24.2 7.5 mDOR, months (95% CI) mDOR, months (95% CI) (9.2-20.6) (5.5-15.8) (7.4-NE) (5.5-15.8) Duration of Response (%) Durat
Slide 15: Safety and Tolerability
15 Safety and Tolerability Safety Population in VIKTORIA-1 Study 2 Arm D: Gedatolisib + Palbociclib + Arm F: Gedatolisib + Fulvestrant Arm E: Alpelisib + Fulvestrant Exposure Fulvestrant (n=153) (n=52) (n=152) Median RDI, Geda (IQR) 93.3 (80.6-100) 100 (97.8-100) -- Median RDI, Alpe (IQR) -- -- 81.7
Slide 16: Summary
Summary • Gedatolisib + fulvestrant ± palbociclib significantly improved PFS compared with alpelisib + fulvestrant in patients with HR+/HER2-/PIK3CA-MT ABC in VIKTORIA-1 Study 2 − Gedatolisib triplet: mPFS 11.1 months (HR, 0.50; 95% CI, 0.37-0.68; P < 0.0001) − Gedatolisib doublet: mPFS 11.3 months
Slide 17: Key Takeaway Points/Conclusions
Key Takeaway Points/Conclusions Gedatolisib + fulvestrant ± palbociclib Treatment discontinuation of doubled median PFS gedatolisib combinations compared with alpelisib + fulvestrant due to adverse events was low (<4%) in patients with HR+/HER2-/PIK3CA-MT ABC VIKTORIA-1 is the first Phase 3 study to
Slide 18: Acknowledgements
Acknowledgements • We thank the 362 clinical trial participants and their families/caregivers from the 237 sites in 23 countries for participating in this trial • We thank the VIKTORIA-1 Study 2 investigators and their staff who participated in this work • We are grateful for the participation and i
Slide 19: VIKTORIA-1 Lay Summary
19 VIKTORIA-1 Lay Summary What is the VIKTORIA-1 Study? Key results of VIKTORIA-1 Study 2 • VIKTORIA-1 is a two-part Phase 3 study to test whether an • For people who received gedatolisib plus fulvestrant, with or investigational drug called gedatolisib combined with without palbociclib, it took nea