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
Celcuity presented updated Phase 1b/2 data at ESMO 2026 showing median rPFS of 15.7 months and a 82.2% six-month rPFS rate with gedatolisib plus darolutamide in mCRPC patients with prior abiraterone exposure. In prior enzalutamide patients, median rPFS was 9.1 months with a 62.5% six-month rPFS rate; PSA50 response rates rose with dose, reaching 67% at the 240-mg level.
Key figures
- Drug Name
- gedatolisib (REVTORPYK) plus darolutamide
- Phase Of Trial
- Phase 1b/2
- Grade3 trae rate
- 20%
- Patients enrolled
- 45
- Phase2 initiation
- first half of 2027
- Rpfs6 prior abiraterone
- 82.2%
- Rpfs6 prior enzalutamide
- 62.5%
- Median rpfs prior abiraterone
- 15.7 months
- Median rpfs prior enzalutamide
- 9.1 months
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