Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma
Open accessAbstract
BACKGROUND: Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options. METHODS: In this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine. The coprimary end points were overall survival and progression-free survival, which were assessed among all patients and among patients who had a tumor PD-1 ligand (PD-L1) combined positive score (the percentage of PD-L1-expressing tumor and infiltrating immune cells relative to the total number of tumor cells) of 10% or more. RESULTS: The median overall survival in the total population was 10.3 months (95% confidence interval [CI], 8.0 to 11.8) in the pembrolizumab group, as compared with 7.4 months (95% CI, 6.1 to 8.3) in the chemotherapy group (hazard ratio for death, 0.73; 95% CI, 0.59 to 0.91; P=0.002). The median overall survival among patients who had a tumor PD-L1 combined positive score of 10% or more was 8.0 months (95% CI, 5.0 to 12.3) in the pembrolizumab group, as compared with 5.2 months (95% CI, 4.0 to 7.4) in the chemotherapy group (hazard ratio, 0.57; 95% CI, 0.37 to 0.88; P=0.005). There was no significant between-group difference in the duration of progression-free survival in the total population (hazard ratio for death or disease progression, 0.98; 95% CI, 0.81 to 1.19; P=0.42) or among patients who had a tumor PD-L1 combined positive score of 10% or more (hazard ratio, 0.89; 95% CI, 0.61 to 1.28; P=0.24). Fewer treatment-related adverse events of any grade were reported in the pembrolizumab group than in the chemotherapy group (60.9% vs. 90.2%); there were also fewer events of grade 3, 4, or 5 severity reported in the pembrolizumab group than in the chemotherapy group (15.0% vs. 49.4%). CONCLUSIONS: Pembrolizumab was associated with significantly longer overall survival (by approximately 3 months) and with a lower rate of treatment-related adverse events than chemotherapy as second-line therapy for platinum-refractory advanced urothelial carcinoma. (Funded by Merck; KEYNOTE-045 ClinicalTrials.gov number, NCT02256436 .).
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Response rates to ICIs range from 15-30% in most solid tumors to 45-60% in melanoma and MSI-H tumors.
“Response rates range from 15 to 30% (in most solid tumors) to 45–60% (in melanoma and MSI-H tumors).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [4]
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Trial watch: immune checkpoint blockers for cancer therapy
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- Authors
- Bellmunt, J., de Wit, R., Vaughn, D. J., Fradet, Y., Lee, J.-L., Fong, L., Vogelzang, N. J., Climent, M. A., Petrylak, D. P., Choueiri, T. K., Necchi, A., Gerritsen, W., Gurney, H., Quinn, D. I., Culine, S., Sternberg, C. N., Mai, Y., Poehlein, C. H., Perini, R. F., & Bajorin, D. F.
- Affiliations
- Radboud University Nijmegen (NL)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Memorial Sloan Kettering Cancer Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-03-16
- Volume
- 376
- Issue
- 11
- Pages
- 1015-1026
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5635424
- OpenAlex
- W2588916311
- Cited by
- 3,395
- References
- 27
- Citations by year
- 2026: 165 · 2025: 236 · 2024: 338 · 2023: 366 · 2022: 424 · 2021: 469 · 2020: 491 · 2019: 388 · 2018: 349 · 2017: 163 · 2016: 1 · 2015: 1 · 2013: 1
- FWCI
- 389.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- PubMed Central (acceptedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Celgene
- BioClinica
- Exelixis
- Les Laboratories Pierre Fabre
- Eisai
- Astellas Pharma
- Genentech
- Takeda Oncology
- National Cancer Institute (P30CA008748)
- Janssen Pharmaceuticals
- Cilag
- Topics
- Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Keywords
- pembrolizumab, advanced urothelial carcinoma, second-line therapy, PD-1 inhibitors, PD-L1 combined positive score, overall survival, progression-free survival, platinum-refractory disease, chemotherapy comparison, paclitaxel, docetaxel, vinflunine, immune checkpoint inhibitors, biomarker-guided therapy, safety and tolerability
- MeSH terms
- Docetaxel, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Urologic Neoplasms, Vinblastine, Survival Analysis, Paclitaxel, Platinum Compounds, Urothelium, Taxoids, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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