Celcuity Inc. announced preliminary clinical data for gedatolisib from two early phase clinical trials, demonstrating encouraging efficacy and safety profiles in metastatic castration-resistant prostate cancer (mCRPC) and HER2-positive metastatic breast cancer (mBC). The data was released on June 30, 2025.
In the Phase 1 portion of the CELC-G-201 trial, evaluating gedatolisib plus darolutamide in mCRPC patients, the six-month radiographic progression-free survival (rPFS) rate was 66%. No patients discontinued gedatolisib due to treatment-related adverse events in this study.
An investigator-sponsored Phase 2 trial of gedatolisib plus trastuzumab-pkrb in HER2+ mBC patients showed an objective response rate (ORR) of 43% in heavily pretreated patients who had received at least three prior anti-HER2 therapies. This regimen also reported no discontinuations due to treatment-related adverse events.
The company noted that the 66% six-month rPFS rate in mCRPC compares favorably to published data for androgen receptor inhibitors in this setting. The 43% ORR in HER2+ mBC patients is also encouraging for a population with limited options, suggesting gedatolisib could be an effective and well-tolerated therapeutic option.
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