Summary:
- 66% six-month radiographic progression-free survival rate in mCRPC trial.
- 43% objective response rate in heavily pre-treated HER2+ breast cancer patients.
- No treatment-related adverse events led to discontinuations in either trial.
Celcuity Inc. (CELC, Financial) announced promising preliminary results from two early-phase clinical trials evaluating gedatolisib, a multi-target inhibitor. The Phase 1 trial, conducted on metastatic castration-resistant prostate cancer (mCRPC) patients, showed a six-month radiographic progression-free survival rate of 66% when gedatolisib was combined with darolutamide.
In a separate Phase 2 trial targeting HER2+ metastatic breast cancer, gedatolisib, when combined with trastuzumab-pkrb, achieved an objective response rate of 43%. Noteworthy among the heavily pre-treated patient group, the median progression-free survival was 6.0 months, with a median overall survival reaching 24.7 months.
Both studies highlighted a favorable safety profile, with no patients discontinuing gedatolisib due to treatment-related adverse events. Importantly, Celcuity plans to explore additional dosing options in the mCRPC trial to pinpoint the recommended Phase 2 dose, aiming to optimize efficacy while maintaining the drug's strong tolerability.
These initial findings are generating interest due to the challenging nature of the patient populations involved. Gedatolisib's potential as a well-tolerated therapeutic option for difficult-to-treat cancer types positions it as a promising candidate in ongoing clinical research efforts.
