Shots:
- The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states
- Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)
- In the trial, the combination showed improved EFS (1EP) by 60% vs surgery alone, with mEFS not reached vs 15.7mos.; OS results (2EP) showed a 50% lower death risk (mOS: not reached vs 41.7mos.), while pCR rate was 57.1% vs. 8.6%
Ref: Merck | Image: Merck | Press Release
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