Celcuity Showcases Promising Phase 3 Data at ESMO Congress

Author: Henry Turner Updated: 09-22-2025 09:17 AM

Celcuity's Presentation of VIKTORIA-1 Trial Results

Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company dedicated to developing targeted oncology therapies, is thrilled to announce its participation at the significant European Society of Medical Oncology (ESMO) Congress. During this esteemed event, Celcuity will share groundbreaking findings from its pivotal Phase 3 VIKTORIA-1 trial.

Details of the Late Breaking Oral Presentation

This important presentation, focusing on the PIK3CA wild-type cohort of the VIKTORIA-1 trial, is scheduled for October 18, 2025. Attendees can expect in-depth insights regarding the efficacy and safety of the innovative combination therapy involving gedatolisib.

Presentation Title and Timing

The oral presentation is titled:
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

Significance of the VIKTORIA-1 Trial

The VIKTORIA-1 trial is crucial as it evaluates the effectiveness of gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor, used in conjunction with fulvestrant and optional palbociclib for patients dealing with HR+/HER2- advanced breast cancer. By comprehensively targeting the PAM pathway, gedatolisib presents a noteworthy advancement compared to other treatments that only address PI3K?, AKT, or mTORC1 individually. The trial has already concluded enrollment for the PIK3CA wild-type cohort, yet continues to seek participants for the PIK3CA mutant cohort, marking a pivotal moment in breast cancer treatment research.

Further Expansions in Clinical Research

Moreover, Celcuity is not stopping at VIKTORIA-1. The company is actively conducting additional studies, such as the Phase 1/2 CELC-G-201 trial, which investigates the combination of gedatolisib and darolutamide in patients with metastatic castration-resistant prostate cancer. Another trial, the VIKTORIA-2 study, aims to assess the potential of gedatolisib combined with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer.

About Celcuity: Innovations in Cancer Treatment

Celcuity Inc. prioritizes developing targeted therapies to enhance the lives of cancer patients. With a robust pipeline centered around the unique properties of gedatolisib, Celcuity strives to meet the pressing needs of patients battling various solid tumors. Their commitment to research and development is driven by a passion for unearthing innovative solutions in the oncology space. For more information, you can visit www.celcuity.com.

Frequently Asked Questions

What is the VIKTORIA-1 trial?

The VIKTORIA-1 trial evaluates the combination of gedatolisib and fulvestrant in treating patients with HR+/HER2- advanced breast cancer.

When will the results from the VIKTORIA-1 trial be presented?

The results will be presented on October 18, 2025, during a session at the ESMO Congress.

What is gedatolisib?

Gedatolisib is a novel pan-PI3K and mTORC1/2 inhibitor that targets the PAM pathway, differentiating itself from other therapies.

What are the implications of the VIKTORIA-1 trial?

This trial could provide critical insights into the efficacy of gedatolisib combined with fulvestrant for treating advanced breast cancer.

How can I learn more about Celcuity's trials?

Further details regarding Celcuity’s ongoing clinical trials can be found on their website at www.celcuity.com.

About The Author

Hi there, As a writer and financial specialist, Henry Turner is passionate about guiding people through the complex world of finance. Having worked in finance for many years, I am an expert at simplifying difficult financial ideas into understandable, useful insights for my blog and articles. My goal is to arm you with the confidence and information you need to make wise financial choices.

Writing for a number of financial blogs has allowed me to interact with readers from novice investors looking for fresh ideas to seasoned investors starting their financial journeys. My mission is to enable everyone to understand and access finance, so enabling you to confidently and clearly reach your financial goals. I appreciate you traveling with me toward success and financial literacy.

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