Celcuity Inc. has announced an expansion of its Phase 3 VIKTORIA-2 clinical trial, which is evaluating gedatolisib as a first-line treatment for patients with HR+/HER2- advanced breast cancer. The trial now includes endocrine-sensitive patients, broadening the potential patient population for this investigational therapy.
Gedatolisib is a pan-PI3K/mTOR inhibitor designed to target key signaling pathways involved in cancer cell growth. The VIKTORIA-2 trial aims to assess its efficacy and safety in combination with standard endocrine therapy, such as letrozole or fulvestrant, compared to endocrine therapy alone.
The expansion to include endocrine-sensitive patients is based on emerging data suggesting that gedatolisib may benefit a wider range of patients, including those who have not previously progressed on endocrine therapy. This decision follows discussions with regulatory authorities and aims to accelerate the development of this potential treatment option.
Celcuity expects to enroll additional patients in the trial, with top-line results anticipated in the coming years. The company emphasizes that all information is based on verified press releases and regulatory filings as of May 14, 2026.
