Keytruda + Padcev reduced risk of EFS and death for muscle-invasive bladder cancer when given before and after surgery

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Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 47% and reduced the risk of death by 35% when given before and after surgery versus neoadjuvant chemotherapy and surgery in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. 

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Exploratory analyses of the POTOMAC phase III trial showed adding one year of treatment with AstraZeneca’s Imfinzi (durvalumab) to BCG induction and maintenance therapy reduced the number of high-risk disease recurrences within the first year, with fewer BCG-unresponsive recurrences in patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer compared to BCG treatment alone.
High-level results from a planned interim analysis of the VOLGA phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with muscle-invasive bladder cancer versus standard of care. 
FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.

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