Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as 1L Treatment of Locally Advanced or Metastatic Urothelial Cancer
- The US FDA has approved Merck’s Keytruda (anti-PD-1 therapy) in combination with Padcev for adult patients with LA/mUC who are not eligible for cisplatin-containing CT
- The approval was based on the (KEYNOTE-869) open-label, multi-cohort (dose escalation cohort, cohort A, cohort K) study evaluating Keytruda + enfortumab vedotin in 121 patients. The study was conducted in collaboration with Seagen & Astellas
- The results showed ORR of 68% with CR and PR rates of 12% and 55%, respectively in the combined efficacy analysis of the dose escalation cohort, cohort A & cohort K (n=121). For the dose escalation cohort + cohort A & cohort K, m-DoR was 22.1mos. & was not reached, median follow-up time 44.7 & 14.8mos., respectively
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