The sNDA was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study includes OS & PFS & 2EPs include ORR, DoR & safety
The study met its dual 1EPs & depicted a mOS of 31.5mos. vs 16.1mos. (reducing the risk of death by 53%) & mPFS of 12.5mos. vs 6.3mos. (reducing the risk of death by 55%). The results were presented at ESMO 2023
Padcev is an ADC developed to function against Nectin-4, the protein located on the surface of cells expressed in bladder cancer. The combination of Padcev + Keytruda was approved by the US FDA in Dec 2023
Ref: Astellas | Image: Astellas
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