Celcuity Reports Positive Phase 3 Trial Results for Gedatolisib in Wild-Type ABC.

Celcuity's phase 3 VIKTORIA-1 trial results are positive, using gedatolisib in combination with other therapies for PIK3CA wildtype HR+/HER2- advanced breast cancer. This leads to an end-of-year catalyst in 2025.

Celcuity Inc. (NASDAQ: CELC) recently announced positive topline results from its phase 3 VIKTORIA-1 clinical trial, which evaluated the efficacy of gedatolisib in combination with fulvestrant with or without palbociclib for the treatment of PIK3CA wild-type HR+/HER2- advanced breast cancer (ABC). The trial, which enrolled 701 patients, demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for both the triplet and doublet regimens compared to standard-of-care fulvestrant.

The gedatolisib triplet regimen, which included gedatolisib, palbociclib, and fulvestrant, reduced the risk of disease progression or death by 76% (HR=0.24; 95% CI: 0.17–0.35; p0.0001) and achieved a median PFS of 9.3 months compared to 2.0 months with fulvestrant. Similarly, the gedatolisib doublet regimen, which included gedatolisib and fulvestrant, reduced the risk of progression or death by 67% (HR=0.33; 95% CI: 0.24–0.48; p0.0001) and achieved a median PFS of 7.4 months compared to fulvestrant [1].

The favorable safety profile of the gedatolisib triplet and doublet regimens was also highlighted, with treatment discontinuation rates lower than those observed in previous trials involving approved drug combinations for HR+/HER2- ABC. Additionally, the incidence of adverse events such as hyperglycemia and stomatitis was lower with the gedatolisib regimens [1].

Sara Hurvitz, SVP of clinical research division at Fred Hutchinson Cancer Center, emphasized the potential practice-changing nature of the results, noting that the topline data from VIKTORIA-1 represent the first phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer where there was a quadrupling of the likelihood of survival without disease progression relative to the study control [1].

Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025, following the presentation of full data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial at an upcoming medical conference later this year. This development could serve as a significant catalyst for the company, given the high unmet medical need in this patient population [1].

The trial results also underscore the potential for gedatolisib to become a transformative new medicine in the treatment of HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, which is a significant burden in the United States. According to Breastcancer.org, approximately 316,950 women will be diagnosed with invasive breast cancer by the end of 2025, highlighting the need for effective and innovative treatment options [2].

References:
[1] Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial. GlobeNewswire. July 28, 2025. Accessed July 28, 2025. https://www.globenewswire.com/news-release/2025/07/28/3122331/0/en/Celcuity-Announces-Clinically-Meaningful-Improvement-in-Both-Progression-Free-Survival-PFS-Primary-Endpoints-from-PIK3CA-Wild-Type-Cohort-of-Phase-3-VIKTORIA-1-Trial.html
[2] Breast Cancer Facts and Statistics. Breastcancer.org. Accessed July 28, 2025. https://www.breastcancer.org/facts-statistics?gad_source=1&gad_campaignid=2038810&gbraid=0AAAAAD_jk-7hc0H5pD_vkzOWGTPpKXSbv&gclid=CjwKCAjwv5zEBhBwEiwAOg2YKNPKSUZkEnRIxAUhkyTmpToVBE_bP_XHuS17q6YvRFVduloAuz3r7BoCWfAQAvD_BwE