{"doi":"10.1200/jco.19.01213","title":"Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer","abstract":"PURPOSE: The phase II single-arm KEYNOTE-052 study evaluated the efficacy and safety of first-line pembrolizumab for patients with locally advanced or metastatic cisplatin-ineligible urothelial carcinoma (UC). PATIENTS AND METHODS: Three hundred seventy patients received pembrolizumab 200 mg intravenously every 3 weeks for up to 24 months. Positive tumor programmed death ligand 1 (PD-L1) expression was defined as combined positive score (CPS) ≥ 10. Response was assessed by independent central review every 9 weeks per RECIST v1.1. The primary end point was objective response rate (ORR). RESULTS: At data cutoff (September 26, 2018), the minimum follow-up was 2 years since the last patient enrolled. ORR was 28.6% (95% CI, 24.1% to 33.5%); 33 patients (8.9%) and 73 patients (19.7%) achieved complete and partial response, respectively. The median duration of response was 30.1 months (95% CI, 18.1 months to not reached [NR]); responses lasted ≥ 12 and ≥ 24 months in 67% and 52% of patients, respectively. Forty patients with complete or partial response completed 2 years of study treatment, and 32 had ongoing response at completion. Median overall survival (OS) was 11.3 months (95% CI, 9.7 to 13.1 months), and 12- and 24-month OS rates were 46.9% and 31.2%, respectively. In patients with CPS ≥ 10, ORR was 47.3% (95% CI, 37.7% to 57.0%) and median OS was 18.5 months (95% CI, 12.2 to 28.5 months). In patients with lymph node-only disease, ORR was 49.0% (95% CI, 34.8% to 63.4%), and median OS was 27.0 months (12.4 months to NR). There were no new safety signals. CONCLUSION: First-line pembrolizumab confers meaningful and durable clinical response in cisplatin-ineligible patients with advanced UC and is associated with prolonged OS, particularly with PD-L1 CPS ≥ 10 and lymph node-only disease.","journal":"Journal of Clinical Oncology","year":2020,"id":49111,"datarank":4.858576643713366,"base_score":5.68697535633982,"endowment":5.68697535633982,"self_citation_contribution":0.8530463034509732,"citation_network_contribution":4.005530340262393,"self_endowment_contribution":0.8530463034509732,"citer_contribution":4.005530340262393,"corpus_percentile":null,"corpus_rank":null,"citation_count":294,"citer_count":100,"citers_with_citation_signal":100,"citers_with_endowment":100,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9103,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02335424"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":235726,"name":"Arjun Vasant Balar","orcid":"0000-0003-3949-5656","position":1,"is_corresponding":false},{"id":105144,"name":"Daniel Castellano","orcid":"0000-0002-9106-0687","position":2,"is_corresponding":false},{"id":51075,"name":"Peter H. O’Donnell","orcid":"0000-0003-2650-0049","position":3,"is_corresponding":false},{"id":105136,"name":"Petros Grivas","orcid":"0000-0003-3965-3394","position":4,"is_corresponding":false},{"id":235727,"name":"Joaquim Bellmunt","orcid":"0000-0003-2328-3421","position":5,"is_corresponding":false},{"id":235728,"name":"Thomas Powles","orcid":"0000-0001-7760-4724","position":6,"is_corresponding":false},{"id":108820,"name":"Dean F. Bajorin","orcid":"0000-0003-4001-7088","position":7,"is_corresponding":false},{"id":235729,"name":"Noah M. Hahn","orcid":"0000-0002-1016-9024","position":8,"is_corresponding":false},{"id":238763,"name":"Mary J. Savage","orcid":null,"position":9,"is_corresponding":false},{"id":235730,"name":"Xiao Fang","orcid":"0000-0002-7549-0214","position":10,"is_corresponding":false},{"id":235731,"name":"James Luke Godwin","orcid":"0000-0003-2924-1185","position":11,"is_corresponding":false},{"id":235732,"name":"Tara L. 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Plimack","orcid":"0000-0002-7618-0744","position":15,"is_corresponding":false},{"id":235725,"name":"Jacqueline Vuky","orcid":"0000-0001-5795-3361","position":0,"is_corresponding":true}],"reference_count":21,"raw_metadata":null,"created_at":"2026-07-18T20:36:25.163232Z","pmid":"32552471","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}