FOCUS on Clinical Trials. Today Celcuity announced the results of a Phase-3 clinical trial of Gedatolisib plus fulvestrant in patients with HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer. The Gedatolisib treatment group demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, reducing the risk of disease progression or death by 76% compared to fulvestrant alone. Gedatolisib (PKI-587 and PF-05212384) is a dual PI3K / mTOR inhibitor first developed at Wyeth Labs (Radnor PA), purchased by Pfizer and licensed to Celcuity. Celcuity is planning an NDA for later in 2025.
FOCUS Biomolecules can supply Gedatolisib for research applications. Contact us for more info.
