Celcuity Inc. announced publication of an abstract reporting updated results for treatment-naïve patients from the Phase 1b study of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib and letrozole in women with HR+/HER2- advanced breast cancer (ABC). A poster will be presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress, which is being held May 11-13, 2023 in Berlin, Germany. In the poster presentation, updated efficacy and safety data in treatment-naïve patients from Escalation Arm A and Expansion Arm, with a June 29, 2022 database lock and median progression-free survival (mPFS) and duration of response (DOR) updated as of March 16, 2023, will be reported.

For Expansion Arm A, median PFS was 48.6 months (n=30), and the objective response rate (ORR) was 85% (n=26, measurable and evaluable disease). When treatment naïve patients from both arms are combined, mPFS was 48.6 months (n=41) and ORR was 79% (n=33, measurable and evaluable disease).