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Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at the 2022 San Antonio Breast Cancer Symposium
High response rates and encouraging median progression free survival rates were observed in patients regardless of PIK3CA mutation statusMedian progression
About this update from Celcuity Inc.
[{"type":"text","content":"High response rates and encouraging median progression free survival rates were observed in patients regardless of PIK3CA mutation statusMedian progression free survival (PFS) of 42.3 months was reported for patients who were treatment naïve in the advanced settingMINNEAPOLIS, MN / ACCESSWIRE / December 9, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that updated results from a Phase 1b trial evaluating gedatolisib were presented during a Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium (SABCS).The presentation reported updated efficacy and safety data and sub-group analysis by PIK3CA mutation status in the four expansion arms of the Phase 1b study. Additional analysis of efficacy results from patients who were treatment-naïve in the advanced setting was also performed.\"The comparable efficacy reported in patients with and without PIK3CA mutations is very encouraging. We believe these results reflect gedatolisib's unique mechanism of action,\" said Brian Sullivan, Celcuity's Chief Executive Officer and co-founder. \"We are also very encouraged by the median PFS of 42.3 months reported for patients with advanced disease who were treatment naïve. These results compare favorably to published data for current standard-of-care regimens for patients with advanced disease who are treatment naïve. The results warrant further evaluation of gedatolisib in combination with a CDK4/6 inhibitor and endocrine therapy in early line settings, including first-line, neoadjuvant, or adjuvant indications.\"A trial-in-progress poster describing Celcuity's Phase 3 clinical trial, VIKTORIA-1, was also presented at SABCS. This poster and the poster presenting updated Phase 1b results are available on the publications page of the Celcuity website.Phase 1b Study Design and ResultsPatients with HR+/HER2- advanced breast cancer were treated with gedatolisib combined with the CDK4/6 inhibitor, palbociclib, and endocrine therapy (either fulvestrant or letrozole). This study included two dose escalation and four dose expansion arms and enrolled a total of 138 patients. Preliminary efficacy and safety results were presented in 2021 (Layman 2021). Updates presented at the 2022 SABCS included efficacy results for patient sub-groups ...