Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as 1L Treatment of Locally Advanced or Metastatic Urothelial Cancer
Shots:
- 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
Ref: merck | Image: merck
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
