Celcuity Inc. · NASDAQ:CELC
Celcuity — 2025 San Antonio Breast Cancer Symposium (SABCS)
18 slides from Celcuity's conference presentation, Dec 11, 2025
Slide 1: Gedatolisib plus fulvestrant with or without palbociclib: updated VIKTORIA-1 results
Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/ PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial Barbara Pistilli, Rachel M. Layman, Giuseppe Curiglia
Slide 2: Disclosure Information
Disclosure Information Barbara Pistilli, MD I have the following relevant financial relationships to disclose: • Consulting fees: AstraZeneca (institutional), Seagen (institutional), Gilead (institutional), Novartis (institutional), Lilly (institutional), MSD (institutional), Pierre Fabre (personal)
Slide 3: Background
Background • The PI3K/AKT/mTOR (PAM) pathway drives breast cancer growth and contributes to ET and CDK4/6i resistance – Most available therapies are indicated only for patients with PI3K-pathway activation1,2 – There remains a need for safe, effective therapies for PIK3CA-WT disease • In VIKTORIA-1
Slide 4: PFS by TTP on Immediate Prior Therapy: Gedatolisib Triplet vs. Fulvestrant
PFS by TTP on Immediate Prior Therapy: Gedatolisib Triplet vs. Fulvestrant Geda + Geda + >6 Months Palbo + Fulvestrant >12 Months Palbo + Fulvestrant Fulvestrant Fulvestrant 100 9.9 1.9 100 10.7 1.9 Progression-Free Survival (%) Progression-Free Survival (%) mPFS, months (95% CI) (7.2, 19.2) (1.8, 2
Slide 5: PFS by TTP on Immediate Prior Therapy: Gedatolisib Doublet vs. Fulvestrant
PFS by TTP on Immediate Prior Therapy: Gedatolisib Doublet vs. Fulvestrant >6 Months Geda + Fulvestrant >12 Months Geda + Fulvestrant Fulvestrant Fulvestrant 7.6 1.9 100 9.1 1.9 100 Progression-Free Survival (%) Progression-Free Survival (%) mPFS, months (95% CI) mPFS, months (95% CI) (5.5, 13.6) (1
Slide 6: PFS by Bone Metastases Status: Bone Only vs. Non-Bone Only
PFS by Bone Metastases Status: Bone Only vs. Non-Bone Only Gedatolisib Triplet Geda + Palbo + Fulvestrant Gedatolisib Doublet Geda + Fulvestrant Fulvestrant Fulvestrant Bone Only Bone Only NR 8.2 100 NR 8.2 100 mPFS, months (95% CI) (7.0, NE) (1.7, NE) mPFS, months (95% CI) (3.5, NE) (1.7, NE) Progr
Slide 7: Stomatitis: Time to First Onset
Stomatitis: Time to First Onset Gedatolisib + Palbo + Gedatolisib + Fulvestrant Event Fulvestrant (n=130) (n=130) Pts with treatment-related stomatitis*†, n (%) 90 (69.2%) 74 (56.9%) Median time to onset (first instance), days (range) 7.5 (1-259) 4.0 (1-524) Grade 1 n=57 8.0 (1-259) n=48 4.5 (1-524)
Slide 8: Stomatitis: Time to First Onset by Week and Grade
Stomatitis: Time to First Onset Safety Analysis Set, Weeks 1-24 40 35 Time to First Onset by Week and Grade, Gedatolisib Triplet 30 Incidence (%) 25 20 Grade 1 2 3 15 10 5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time to First Onset (Weeks) 40 35 Time to First Onset by Week a
Slide 9: Stomatitis: Time to Improvement
Stomatitis: Time to Improvement Gedatolisib + Palbo + Gedatolisib + Fulvestrant Event Fulvestrant (n=130) (n=130) Pts with treatment-related stomatitis*†, n (%) 90 (69.2%) 74 (56.9%) Median time to improvement (from worst grade), days (range) Grade 3 to lower n=25 12.0 (3-103) n=16 7.5 (2-112) Grade
Slide 10: Median Glucose Levels Were Stable
Median Glucose Levels Were Stable Median Fasting Glucose Levels Over Time Geda + Palbo + Gedatolisib + Plasma Fasting Fulvestrant Geda + Palbo + Fulvestrant Hyperglycemia, n (%) Fulvestrant Fulvestrant 7.0 Geda + Fulvestrant (n=123) Fulvestrant (n=130) (n=130) 6.5 Glucose (mmol/L) 5.0 Upper: 5.5 5.5
Slide 11: PRO: Temporal and Mean Change, EQ-5D-5L
PRO: Temporal and Mean Change, EQ-5D-5L Time to Definitive Deterioration in EQ-5D-5L Mean Changes from BL in EQ-5D-5L Geda + Palbo Geda + + Fulvestrant Fulvestrant Fulvestrant EQ-5D Index Score of UK Value Set (%) (n=123) (n=122) (n=113) 0.2 100 23.7 NR 4.0 90 Median time, mo. (95% CI) (6.8-NE) (7.1
Slide 12: Conclusions
Conclusions • VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in PFS with PAM inhibition in patients with PIK3CA-WT disease, all of whom received prior CDK4/6i • Significant efficacy was observed irrespective of the duration of prior tre
Slide 13: Acknowledgments
Acknowledgments • We thank the 392 clinical trial participants and their families/caregivers from the 147 sites in 23 countries for participating in this trial • We thank the VIKTORIA-1 investigators and their staff who participated in this work • We are grateful for the participation and insights o
Slide 14: Supplementary Material
Supplementary Material This presentation is the intellectual property of the author/presenter. Contact them at Barbara.Pistilli@gustaveroussy.fr for permission to reprint and/or distribute.
Slide 15: VIKTORIA-1 Study Design
VIKTORIA-1 Study Design Abbreviations: ABC, advanced breast cancer; AKTi, protein kinase B inhibitor; BICR, blinded independent central review; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ET, endocrine therapy; HbA1c, hemoglobin A1c; HER2-, human epidermal growth factor receptor 2-negative;
Slide 16: Co-Primary Endpoints: Progression-Free Survival (BICR)
Co-Primary Endpoints: Progression-Free Survival (BICR) Gedatolisib triplet and gedatolisib doublet vs. fulvestrant Geda + Palbo Geda + 100 + Fulvestrant Fulvestrant 100 Fulvestrant Fulvestrant (n=131) (n=131) (n=130) (n=131) 90 9.3 2.0 90 7.4 2.0 Median OS, months (95% CI) (7.2-16.6) (1.8-2.3) Media
Slide 17: Interim OS, Censored at Cross-Over
Interim OS, Censored at Cross-Over Gedatolisib triplet and gedatolisib doublet vs. fulvestrant Geda + Palbo Geda + + Fulvestrant Fulvestrant Fulvestrant Fulvestrant (n=131) (n=131) (n=130) (n=131) 23.7 15.8 NR 15.8 Median OS, months (95% CI) (21.4-NE) (11.7-NE) Median OS, months (95% CI) 100 (NE-NE)
Slide 18: PFS by Region: US/Canada/Western Europe/Asia Pacific vs. Rest of World
PFS by Region US/Canada/Western Europe/Asia Pacific vs. Rest of World Gedatolisib Triplet Geda + Palbo + Fulvestrant Gedatolisib Doublet Geda + Fulvestrant Fulvestrant Fulvestrant 100 16.6 1.9 100 7.1 1.9 mPFS, months (95% CI) (8.9, 19.3) (1.8, 2.0) mPFS, months (95% CI) (3.7, 9.9) (1.8, 2.0) Progre
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