Celcuity prostate trial results announced on October 23, 2026, showed early efficacy signals for gedatolisib combined with darolutamide in metastatic castration-resistant prostate cancer. The Phase 1b/2 study included 45 patients, with median radiographic progression-free survival differing between groups defined by prior treatment.
Key Takeaways
- Median radiographic progression-free survival was 15.7 months after prior abiraterone and 9.1 months after prior enzalutamide.
- Prostate-specific antigen reductions were observed across all three gedatolisib dose groups.
- The early-stage findings support further evaluation but do not establish superiority over another treatment.
Table of Contents
- Celcuity prostate trial tests a two-drug combination
- Progression findings differ by previous therapy
- Safety findings remain early-stage
- Conclusion
Celcuity prostate trial tests a two-drug combination
Celcuity’s CELC-G-201 study design evaluates gedatolisib plus darolutamide in patients previously treated with an androgen-receptor inhibitor for metastatic castration-resistant prostate cancer. The company’s clinical-trials page lists the Phase 1/2 study as ongoing and enrolling patients.
The results presented at the ESMO Congress covered 45 patients receiving intravenous gedatolisib alongside darolutamide. Gedatolisib targets the PI3K/AKT/mTOR signaling pathway, while darolutamide is an androgen-receptor inhibitor.
| Item | Details |
|---|---|
| Trial population | Metastatic castration-resistant prostate cancer |
| Gedatolisib dose levels | 120 mg, 180 mg and 240 mg |
| Treatment pairing | Gedatolisib plus darolutamide |
Progression findings differ by previous therapy
Median radiographic progression-free survival—the time before imaging-detected disease progression or death—was 15.7 months in patients previously treated with abiraterone. It was 9.1 months among those previously exposed to enzalutamide.
Those figures describe separate prior-treatment groups, not a comparison against a control therapy. They therefore do not establish that the combination is more effective than an alternative treatment or explain why outcomes differed between the groups.
Celcuity also reported reductions in prostate-specific antigen, or PSA, across all dosage groups. The supplied results did not quantify the size of those reductions or the proportion of patients meeting a defined PSA-response threshold.
Safety findings remain early-stage
Celcuity described the safety profile as manageable, with few severe adverse events. All participants received preventive treatment for stomatitis, or inflammation inside the mouth.
The available summary did not provide detailed adverse-event rates or treatment-discontinuation figures. That limits how precisely tolerability can be assessed alongside the reported efficacy signals.
Conclusion
The Celcuity prostate trial provides early evidence of activity for the combination, rather than a definitive comparative result. CELC-G-201 remains ongoing, with enrollment continuing as the company evaluates the regimen.
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