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Update Sustains Frontline Pembrolizumab Benefit in Urothelial Carcinoma

Jason Harris
Published: Monday, Jun 26, 2017

Peter H. O’Donnell, MD

Peter H. O’Donnell, MD

Updated phase II results from the KEYNOTE-052 trial showed that first-line treatment with pembrolizumab (Keytruda) produced a long-lasting response for patients with cisplatin-ineligible advanced urothelial cancer.1

Based on data from the KEYNOTE-052 trial, the FDA granted an accelerated approval in May 2017 for the accelerated approval to frontline pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.


  1. O’Donnell PH, Grivas P, Balar AV, et al. Biomarker findings and mature clinical results from KEYNOTE-052: First-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC). J Clin Oncol. 35, 2017 (suppl; abstr 4502).
  2. Balar A, Bellmunt J, O’Donnell PH, et al. Pembrolizumab (pembro) as first-line therapy for advanced/unresectable or metastatic urothelial cancer: Preliminary results from the phase II KEYNOTE-052 study. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA32.

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