Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress
Celcuity (NASDAQ:CELC), a clinical-stage biotech company, has announced that results from its pivotal Phase 3 VIKTORIA-1 trial will be presented at the 2025 ESMO Congress in October. The late-breaking presentation will focus on efficacy and safety data from the PIK3CA wild-type cohort, specifically examining gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in HR+/HER2- advanced breast cancer patients.
The presentation is scheduled for October 18, 2025, from 10:15 am to 11:45 am CEST, with the abstract number 3535. The late-breaking abstracts will be published on ESMO's website on the presentation day.
Celcuity (NASDAQ:CELC), una società bio tech in fase clinica, ha annunciato che i risultati del suo studio decisivo Phase 3 VIKTORIA-1 saranno presentati al Congresso ESMO 2025 in ottobre. La presentazione di ultima ora si concentrerà su dati di efficacia e sicurezza della coorte PIK3CA wild-type, esaminando specificamente gedatolisib più fulvestrant con o senza palbociclib rispetto a fulvestrant in pazienti con cancro al seno avanzato HR+/HER2-.
La presentazione è prevista per 18 ottobre 2025, dalle 10:15 alle 11:45 CEST, con il numero di abstract 3535. Gli abstract di ultima ora saranno pubblicati sul sito ESMO nella giornata della presentazione.
Celcuity (NASDAQ:CELC), una empresa biotecnológica en etapa clínica, ha anunciado que los resultados de su ensayo pivotal de fase 3 VIKTORIA-1 se presentarán en el Congreso ESMO 2025 en octubre. La presentación de última hora se centrará en datos de eficacia y seguridad de la cohorte con PIK3CA wild-type, examinando específicamente gedatolisib más fulvestrant con o sin palbociclib frente a fulvestrant en pacientes con cáncer de mama avanzado HR+/HER2-.
La presentación está programada para el 18 de octubre de 2025, de 10:15 a 11:45 CEST, con el número de resumen 3535. Los abstracts de última hora se publicarán en el sitio web de ESMO el día de la presentación.
Celcuity (NASDAQ:CELC)는 임상단계 생명공학 회사로, 주요 Phase 3 VIKTORIA-1 시험의 결과가 10월 2025 ESMO Congress에서 발표될 것이라고 발표했습니다. 이번 Late-breaking 발표는 PIK3CA 와일드타입 코호트의 효능 및 안전성 데이터를 중심으로, HR+/HER2- 진행성 유방암 환자에서 gedatolisib+fulvestrant와 palbociclib 여부에 관계없이 fulvestrant를 비교합니다.
발표는 2025년 10월 18일 10:15–11:45 CEST 사이에 예정되어 있으며 초록 번호는 3535번입니다. Late-breaking 초록은 발표 당일 ESMO 웹사이트에 게시됩니다.
Celcuity (NASDAQ:CELC), une société biotechnologique en phase clinique, a annoncé que les résultats de son essai pivot Phase 3 VIKTORIA-1 seront présentés au Congrès ESMO 2025 en octobre. La présentation late-breaking portera sur les données d’efficacité et de sécurité de la cohorte PIK3CA wild-type, en examinant spécifiquement gedatolisib plus fulvestrant avec ou sans palbociclib par rapport à fulvestrant chez les patientes atteintes d’un cancer du sein avancé HR+/HER2-.
La présentation est prévue pour le 18 octobre 2025, de 10h15 à 11h45 CEST, avec le numéro d’abstract 3535. Les abstracts late-breaking seront publiés sur le site d’ESMO le jour de la présentation.
Celcuity (NASDAQ:CELC), ein klinisch entwickeltes Biotech-Unternehmen, gab bekannt, dass Ergebnisse aus seinem wichtigen Phase-3-VIKTORIA-1-Studie auf dem ESMO-Kongress 2025 im Oktober vorgestellt werden. Die reif geborene Präsentation konzentriert sich auf Wirksamkeits- und Sicherheitsdaten aus der PIK3CA-wild-type-Kohorte, wobei gedatolisib plus Fulvestrant mit oder ohne Palbociclib gegenüber Fulvestrant bei HR+/HER2- fortgeschrittenem Brustkrebs untersucht werden.
Die Präsentation ist für den 18. Oktober 2025 von 10:15 bis 11:45 CEST vorgesehen, mit der Abstract-Nummer 3535. Die Late-Breaking-Abstracts werden am Tag der Präsentation auf der ESMO-Website veröffentlicht.
Celcuity (NASDAQ:CELC)، شركة تقنيات حيوية في المرحلة السريرية، أعلنت أن نتائج تجربتها الحاسمة Phase 3 VIKTORIA-1 ستُعرض في اجتماع ESMO 2025 في أكتوبر. ستركز العرض المتأخر على بيانات الفعالية والسلامة من مجموعة PIK3CA wild-type، مع فحص gedatolisib مع fulvestrant مع أو بدون palbociclib مقارنةً بـ fulvestrant لدى مرضى سرطان الثدي المتقدم HR+/HER2-.
المحاضرة مقررة في 18 أكتوبر 2025، من 10:15 صباحاً حتى 11:45 صباحاً بتوقيت وسط أوروبا الصيفي، مع رقم الملخص 3535. ستُنشر الملخصات المتأخرة على موقع ESMO في يوم العرض.
Celcuity（纳斯达克股票代码 CELC），一家处于临床阶段的生物技术公司，宣布其关键性3 期 VIKTORIA-1 试验的结果将于十月在2025 年 ESMO 大会上进行报道。此次晚期报道将聚焦PIK3CA野生型队列的疗效和安全性数据，具体比较 gedatolisib 加 fulvestrant，是否联合 palbociclib，与 HR+/HER2- 的晚期乳腺癌患者中的 fulvestrant。
该报告定于2025 年 10 月 18 日，在 CEST 时间 10:15-11:45，摘要编号为 3535。晚期摘要将于演讲当天在 ESMO 官网公布。
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MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial.
Late Breaking Oral Presentation Details:
Title: Gedatolisib + fulvestrant ± palbociclib vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: First results from VIKTORIA-1
Abstract Number: 3535
Session Title: Proffered paper session 1: Breast Cancer, metastatic
Date: October 18, 2025
Time: 10:15 am – 11:45 am CEST
Late-breaking abstracts (LBA) accepted for a Proffered Paper Session at the ESMO Congress 2025 will be published online via the ESMO website on the day of presentation.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is 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- advanced breast cancer (“ABC”) has completed enrollment of and reported topline data for the PIK3CA wild-type cohort, and is currently enrolling patients for the PIK3CA mutant cohort. 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. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. 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.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284
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