Celcuity reports median rPFS of 15.7 months for gedatolisib plus darolutamide in abiraterone‑pretreated mCRPC patients
Celcuity Inc. presented updated Phase 1b/2 data for its gedatolisib‑darolutamide combination in metastatic castration‑resistant prostate cancer. In the 22 patients who had previously received abiraterone, the median radiographic progression‑free survival was 15.7 months and 82.2% were progression‑free at six months. Patients previously treated with enzalutamide (n=18) showed a median rPFS of 9.1 months and a six‑month rPFS rate of 62.5%. The company plans to start the Phase 2 portion of the trial in the first half of 2027.
Why it matters
The longer rPFS observed in abiraterone‑pretreated patients suggests the regimen could become a new treatment option for that subgroup, potentially expanding Celcuity’s market opportunity. The upcoming Phase 2 study will determine the recommended Phase 3 dose and could drive further valuation if results confirm the Phase 1b/2 findings.
Key facts
- 1The Phase 1b/2 study enrolled 45 mCRPC patients who received 600 mg darolutamide twice daily with gedatolisib at 120 mg (19 patients), 180 mg (19 patients) or 240 mg (7 patients). stocktitan.net
- 2Median radiographic progression‑free survival was 15.7 months in patients with prior abiraterone exposure (n=22). stocktitan.net
- 3The six‑month rPFS rate for the abiraterone‑pretreated cohort was 82.2%. stocktitan.net
- 4Median rPFS was 9.1 months in patients with prior enzalutamide exposure (n=18). stocktitan.net
- 5The six‑month rPFS rate for the enzalutamide‑pretreated cohort was 62.5%. stocktitan.net
- 6The Phase 2 portion of the trial is slated to begin in the first half of 2027. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.