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Celcuity Presents Updated Results from Phase 1b Study of Gedatolisib in Treatment-Naïve Patients at the 2023 ESMO Breast Cancer Annual Congress
Median progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in
About this update from Celcuity Inc.
[{"type":"text","content":"Median progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib and letrozoleMedian duration of response (DOR) was 46.9 monthsMINNEAPOLIS, MN / ACCESSWIRE / May 12, 2023 / 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, a pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor, and letrozole, an aromatase inhibitor, were presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany.The presentation reported efficacy and safety data in treatment-naïve patients with HR+, HER2- advanced breast cancer enrolled in Escalation Arm A and Expansion Arm A. Median progression-free survival (mPFS) and median duration of response (mDOR) data was updated as of March 16, 2023. For treatment-naïve patients in Escalation Arm A (n=11) and Expansion Arm A (n=30), median PFS was 45.8 months and 48.6 months, respectively. When treatment-naïve patients from both arms were combined (n=41), mPFS was 48.6 months and mDOR was 46.9 months. Median PFS in Expansion Arm A had not yet been reached when this data was reported at the San Antonio Breast Cancer Symposium last December.\"The median PFS and DOR results reported for gedatolisib in combination with letrozole and palbociclib are very encouraging and compare favorably to published data for current front-line standard-of-care treatments for patients with HR+, HER2- advanced breast cancer,\" said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. \"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.\"Phase 1b Study Design and Results for Treatment-Naïve PatientsThe company's Phase 1b clinical trial enrolled patients with HR+, HER2- advanced breast cancer and treated them with gedatolisib in combination with palbociclib and an endocrine therapy (either fulvestrant or letrozole). The study enrolled a total of 138 patients in two dose escalation and four dose expansion arms. Updated efficacy and safety...