Full Press Release Details
Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort
Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer
Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC
MINNEAPOLIS, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented.
Late Breaking Rapid Oral Presentation Details:
Title: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2) Presentation Number: LBA 16 Speaker: Barbara Pistilli, MD Session Title: Rapid oral 1: Breast cancer, advanced stage Room: Almeria Auditorium - Hall 9 Date: Saturday, October 24, 2026 Time: 10:15 –11:45 a.m. CEST
Poster Presentation Details:
Title: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) Presentation Numbe r: 2237P Presenting Author: Adam Sharp, MD, PhD Session Title: Poster Display session, Metastatic prostate cancer Date: Friday, October 23, 2026 Time: 3:15 p.m. – 4:00 p.m. CEST
Title: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA) Presentation Numbe r: 1873P Presenting Author: Sara Tolaney, MD Session Title: Poster Display session, HR+ breast cancer Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST
Title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy (ET) and Palbociclib vs ET and Ribociclib as First-Line (1L) Treatment in Patients With HR-Positive (HR+) HER2-Negative (HER2-) Advanced Breast Cancer (ABC) (VIKTORIA-2) Presentation Numbe r: 57TiP Presenting Author: Giuseppe Curigliano, MD, PhD Session Title: Poster Display session, Advanced breast cancer, other Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST
Abstracts will be published online via the ESMO website at 12:05 a.m. CEST on October 19, 2026. The posters will be presented in the Poster Area – Hall 5. Electronic versions will also be available on the ESMO 2026 virtual platform.
About Celcuity Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK™ (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.