Celcuity gedatolisib combo shows promise in phase 1b trial in breast cancer patients
Sean Anthony Eddy
Celcuity (NASDAQ:CELC) reported updated data from a phase 1b trial of gedatolisib in combination with Pfizer's (PFE) Ibrance (palbociclib) and Novartis' (NVS) Femara (letrozole) to treat patients with breast cancer at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin.
The study enrolled patients with HR+, HER2- advanced breast cancer who had not received prior treatment. The data is from Escalation Arm A (n=11) and Expansion Arm A (n=30) patients.
The median progression-free survival (mPFS) for Escalation Arm A was 45.8 months, while for the Expansion group was 48.6 months.
PFS is the length of time during/after treatment that a patient lives without the disease getting worse.
For both groups combined (n=41) mPFS was 48.6 months, while median duration of response (mDOR) was 46.9 months.
"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 Chief Medical Officer Igor Gorbatchevsky.
The trial has enrolled a total of 138 patients in two dose escalation and four dose expansion groups. Patients with HR+, HER2- advanced breast cancer are being treated with gedatolisib in combination with palbociclib and an endocrine therapy, either letrozole or fulvestrant, sold as Faslodex by AstraZeneca (AZN).