Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A phase II clinical trial (NCT02335424) of pembrolizumab on 370 patients with urothelial carcinoma reported a satisfactory durable response rate in cisplatin-ineligible patients.
“A phase II clinical trial (NCT02335424) of pembrolizumab on 370 patients with UC reported a satisfactory durable response rate (DRR) in cisplatin-ineligible patients [43].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [43]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534 · see citing works
THE USE OF CONFIDENCE OR FIDUCIAL LIMITS ILLUSTRATED IN THE CASE OF THE BINOMIAL
Clopper, C. J., & Pearson, E. S. (1934) · Biometrika · doi:10.1093/biomet/26.4.404 · Cited by 5,106 · see citing works
Balar, A. V., Galsky, M. D., Rosenberg, J. E., Powles, T., Petrylak, D. P., Bellmunt, J., Loriot, Y., Necchi, A., Hoffman-Censits, J., Perez-Gracia, J. L., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(16)32455-2 · Cited by 2,199 · see citing works
Self-citationUpdated 2016 EAU Guidelines on Muscle-invasive and Metastatic Bladder Cancer
Witjes, J. A., Lebrét, T., Compérat, É., Cowan, N. C., Santis, M. D., Bruins, H. M., Hernández, V., Linares, E., Dunn, J., Rouanne, M., et al. (2016) · European Urology · doi:10.1016/j.eururo.2016.06.020 · Cited by 1,479 · see citing works
Balar, A. V., Castellano, D., O’Donnell, P. H., Grivas, P. D., Vuky, J., Powles, T. B., Plimack, E. R., Hahn, N. M., de Wit, R., Pang, L., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30616-2 · Cited by 1,336 · see citing works
Self-citationSantis, M. D., Joaquim Bellmunt, B., Mead, G. M., Kerst, J. M., Leahy, M. G., Maroto, P., Gil, T., Marreaud, S. I., Daugaard, G., Skoneczna, I., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.37.3571 · Cited by 780 · see citing works
Biomarkers for predicting efficacy of PD-1/PD-L1 inhibitors
Yi, M., Jiao, D., Xu, H., Liu, Q., Zhao, W., Han, X., & Wu, K. (2018) · Molecular Cancer · doi:10.1186/s12943-018-0864-3 · Cited by 756 · see citing works
Treatment of Patients With Metastatic Urothelial Cancer “Unfit” for Cisplatin-Based Chemotherapy
Galsky, M. D., Hahn, N. M., Rosenberg, J. E., Sonpavde, G., Hutson, T. E., Oh, W. K., Dreicer, R., Vogelzang, N. J., Sternberg, C. N., Bajorin, D. F., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.34.8433 · Cited by 708 · see citing works
Self-citationA review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: The future is now
Bellmunt, J., Powles, T., & Vogelzang, N. J. (2017) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2017.01.007 · Cited by 374 · see citing works
Self-citationDogliotti, L., Cartenì, G., Siena, S., et al. (2007) · European Urology · doi:10.1016/j.eururo.2006.12.029 · Cited by 333 · see citing works
Suzman, D. L., Agrawal, S., Ning, Y. M., Maher, V. E., Fernandes, L. L., Karuri, S. W., Tang, S. W., Sridhara, R., Schroeder, J., Goldberg, K. B., et al. (2018) · The Oncologist · doi:10.1634/theoncologist.2018-0084 · Cited by 194 · see citing works
Santis, M. D., Bellmunt, J., Mead, G. M., et al. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2008.21.4924 · Cited by 169 · see citing works
Self-citationKluger, H. M., Zito, C. R., Turcu, G., Baine, M. K., Zhang, H., Adeniran, A., Sznol, M., Rimm, D. L., Kluger, Y., Chen, L., et al. (2017) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-16-3146 · Cited by 151 · see citing works
Prognostic value of PD-L1 expression in tumor infiltrating immune cells in cancers: A meta-analysis
Zhao, T., Li, C., Wu, Y., Li, B., & Zhang, B. (2017) · PLoS ONE · doi:10.1371/journal.pone.0176822 · Cited by 70 · see citing works
Urothelial carcinoma management in elderly or unfit patients
Joaquim Bellmunt, B., Mottet, N., & Santis, M. D. (2016) · European Journal of Cancer Supplements · doi:10.1016/j.ejcsup.2016.01.001 · Cited by 65 · see citing works
Administration of Cisplatin-Based Chemotherapy for Advanced Urothelial Carcinoma in the Community
Sonpavde, G., Watson, D., Tourtellott, M., et al. (2012) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2011.11.005 · Cited by 62 · see citing works
Sonpavde, G., Galsky, M. D., Latini, D. M., et al. (2013) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2013.11.016 · Cited by 50 · see citing works
Powles, T. B., Gschwend, J. E., Loriot, Y., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.15_suppl.tps4590 · Cited by 47 · see citing works
Self-citationXin, R., Gu, T., Pan, H., & Zhang, H. (2018) · International Immunopharmacology · doi:10.1016/j.intimp.2018.12.018 · Cited by 46 · see citing works
Bellmunt, J., de Wit, R., Vaughn, D. J., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.36.6_suppl.410 · Cited by 27 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
PD-L1 as a biomarker of response to immune-checkpoint inhibitors
Doroshow, D. B., Bhalla, S., Beasley, M. B., Sholl, L. M., Kerr, K. M., Gnjatic, S., Wistuba, I. I., Rimm, D. L., Tsao, M. S., & Hirsch, F. R. (2021) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-021-00473-5 · Cited by 1,575 · see citing works
Immune Checkpoint Inhibitors in Cancer Therapy
Shiravand, Y., Khodadadi, F., Kashani, S. M. A., Hosseini-Fard, S. R., Hosseini, S., Sadeghirad, H., Ladwa, R., O’Byrne, K., & Kulasinghe, A. (2022) · Current Oncology · doi:10.3390/curroncol29050247 · Cited by 1,353 · see citing works
- Authors
- Vuky, J., Balar, A. V., Castellano, D., O’Donnell, P. H., Grivas, P., Bellmunt, J., Powles, T., Bajorin, D., Hahn, N. M., Savage, M. J., Fang, X., Godwin, J. L., Frenkl, T. L., Homet Moreno, B., de Wit, R., & Plimack, E. R.
- Affiliations
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Beth Israel Deaconess Medical Center/IMIM research Institute, Harvard Medical School, Boston, MA
- Queen Mary University of London (GB)
- Memorial Sloan Kettering Cancer Center (US)
- Johns Hopkins University (US)
- Merck & Co., Kenilworth, NJ
- Erasmus MC Cancer Institute, Rotterdam, the Netherlands
- Fox Chase Cancer Center (US)
- Corresponding author
- Vuky, Jacqueline
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2020-08-10
- Volume
- 38
- Issue
- 23
- Pages
- 2658-2666
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3036701611
- Cited by
- 291
- References
- 21
- Citations by year
- 2026: 22 · 2025: 37 · 2024: 48 · 2023: 50 · 2022: 64 · 2021: 61 · 2020: 8 · 2013: 1
- FWCI
- 42.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Cleveland Clinic
- University of Washington
- Exelixis
- Celldex Therapeutics
- Les Laboratories Pierre Fabre
- Clovis Oncology
- Mirati Therapeutics
- Incyte
- UroGen Pharma
- Astellas Pharma
- Fidia Farmaceutici
- Ipsen
- Bavarian Nordic
- National Institutes of Health
- Genentech
- EMD Serono
- Foundation Medicine
- Topics
- Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Renal cell carcinoma treatment
- Keywords
- pembrolizumab, urothelial carcinoma, cisplatin-ineligible patients, first-line immunotherapy, PD-L1 expression, combined positive score, objective response rate, duration of response, overall survival, long-term outcomes, metastatic urothelial carcinoma, locally advanced urothelial cancer, immune checkpoint inhibitors
- MeSH terms
- Antineoplastic Agents, Immunological, Adult, Aged, Aged, 80 and over, Cisplatin, Humans, Middle Aged, Urologic Neoplasms, Treatment Outcome, B7-H1 Antigen, 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.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
