Celcuity Presents Updated Results from the PIK3CA MT Cohort of the Phase 3 VIKTORIA-1 Study in Patients with HR+/HER2- Advanced Breast Cancer at the ESMO Congress 2026

Igor Gorbachevsky, Chief Medical Officer of Celcuity

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens.”

Igor Gorbachevsky, Chief Medical Officer of Celcuity

“For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

Igor Gorbachevsky, Chief Medical Officer of Celcuity

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute

“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)”