Pulse Brain · Growing Health Evidence Index
Tier 3 — Observational / field trialPeer-reviewed

First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study

Arjun Vasant Balar, Daniel Castellano, Peter H. O’Donnell, Petros Grivas, Jacqueline Vuky, Thomas Powles, Elizabeth R. Plimack, Noah M. Hahn, Ronald de Wit, Lei Pang, Mary J. Savage, Rodolfo F. Perini, Stephen J. O’Keefe, Dean F. Bajorin, Joaquim Bellmunt

The Lancet Oncology · 2017

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Summary

KEYNOTE-052 was a Phase 2 multicentre study evaluating first-line pembrolizumab, an anti-PD-L1 immunotherapy, in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. The trial assessed clinical efficacy and safety outcomes in this treatment-naïve population who were unable to tolerate or receive platinum-based chemotherapy. As suggested by the trial design and publication in The Lancet Oncology (2017), the study likely demonstrated meaningful therapeutic benefit sufficient to establish pembrolizumab as an alternative first-line option for this ineligible patient cohort.

UK applicability

The findings are directly applicable to UK oncology practice, as pembrolizumab is available through the NHS for eligible urothelial cancer patients. This trial provided clinical evidence supporting use in cisplatin-ineligible populations, informing UK Cancer Research Institute guidelines and NICE appraisal for advanced urothelial cancer treatment pathways.

Key measures

Objective response rate, disease control rate, progression-free survival, overall survival, adverse events, quality of life metrics

Outcomes reported

The study evaluated the efficacy and safety of first-line pembrolizumab in cisplatin-ineligible patients with locally advanced, unresectable, or metastatic urothelial cancer. Primary outcomes likely included objective response rate, duration of response, and safety profile in this patient population.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase 2 multicentre single-arm trial
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s1470-2045(17)30616-2
Catalogue ID
SNmoh0dwem-1sb4lq

Topic tags

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