Phase III Study: Perioperative Padcev & Keytruda Combo Significantly Improves Survival in Bladder Cancer

The Phase III EV-303/KEYNOTE-905 trial found that combining Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) given before and after surgery significantly improved event-free survival (EFS) and overall survival (OS) versus surgery alone in cisplatin-ineligible muscle-invasive bladder cancer (MIBC) patients124.

This combination is the first and only systemic therapy to show survival benefit in perioperative treatment for cisplatin-ineligible MIBC patients, representing a major advance over the previous standard of care, which relied on surgery alone if cisplatin-based chemotherapy was not an option14.

The trial also met the secondary endpoint of improved pathologic complete response (pCR), indicating more patients had no residual cancer at surgery with the combo124.

Padcev plus Keytruda reduced the risk of death by 49% relative to chemotherapy alone, with median overall survival extending to 33.8 months5.

Approximately half of MIBC patients are ineligible for cisplatin, so this new approach could impact a substantial portion of cases14.

Regulatory filings are planned; results will be presented at a future medical meeting23.

Sources:

1. https://www.clinicaltrialsarena.com/news/perioperative-padcev-keytruda-improves-survival-mibc/

2. https://www.biospace.com/press-releases/padcev-plus-keytruda-significantly-improves-survival-for-certain-patients-with-bladder-cancer-when-given-before-and-after-surgery

3. https://www.oncologypipeline.com/apexonco/keytruda-and-padcev-make-early-bladder-cancer-bid

4. https://www.biospace.com/press-releases/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-significantly-improved-event-free-and-overall-survival-and-pathologic-complete-response-rate-for-certain-patients-with-muscle-invasive-bladder-cancer-when-given-before-and-after-surgery

5. https://www.appliedclinicaltrialsonline.com/view/ev-303-keynote-905-padcev-keytruda-improves-event-free-overall-survival-muscle-invasive-bladder-cancer