Celcuity Presents Updated Data from a Phase 1b/2 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration-Resistant Prostate Cancer at the ESMO Congress 2026
Globe Newswire•23/10/2026•09:15 ET
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Key Highlights
- ➤Prior abiraterone patients posted 15.7-month median rPFS and 82.2% six-month rPFS
- ➤Prior enzalutamide patients posted 9.1-month median rPFS and 62.5% six-month rPFS
- ➤PSA50 response rates reached 36%, 47%, and 67% across 120-, 180-, 240-mg doses
- ➤Gedatolisib plus darolutamide produced no Grade 4/5 treatment-related adverse events
- ➤Phase 2 evaluation is expected to begin in the first half of 2027
Expert Statements
Igor Gorbachevsky, Chief Medical Officer of Celcuity
“We are highly encouraged by these results and believe combining gedatolisib with an androgen receptor inhibitor is a promising new approach for patients with mCRPC.”
Igor Gorbachevsky, Chief Medical Officer of Celcuity
“The 82.2% six-month PFS rate and median rPFS of 15.7 months is remarkable in patients who had received prior abiraterone and compares favorably to published data for AR inhibitors in this setting.”
Igor Gorbachevsky, Chief Medical Officer of Celcuity
“We look forward to initiating the Phase 2 portion of the study and further evaluating this combination in more patients.”
Median radiographic progression free survival (“rPFS”) was 15.7 months and the six-month rPFS rate (“rPFS6”) was 82.2% in patients who received prior abiraterone
Median rPFS was 9.1 months and rPFS6 was 62.5% in patients who received prior enzalutamide
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