biotech / news / / The Manila Times
Celcuity announces publication of efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib in the Journal of Clinical Oncology.
The VIKTORIA-1 trial showed gedatolisib triplet increased median PFS to 9.3 months from 2.0 months.
KEY POINTS
- Gedatolisib’s broad inhibition of multiple PI3K/AKT/mTOR nodes differentiates it from current single-target inhibitors.
- In the PIK3CA WT cohort, the gedatolisib triplet reduced disease progression or death risk by 76%.
- FDA has granted Priority Review to Celcuity’s gedatolisib NDA with a target date of July 17, 2026.
COMPANIES
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