Celcuity 将在 ESMO 2026 公布 gedatolisib 多项 VIKTORIA-1 及前列腺癌试验数据

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 Number: 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 Number: 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 Number: 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.

Contacts

For Investors: 
Brian Sullivan, [email protected]
Vicky Hahne, [email protected]   
(763) 392-0123

For investors and media:
Jodi Sievers, [email protected]
(415) 494-9924