PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma Article Swipe
Paul Nghiem
,
Shailender Bhatia
,
Evan J. Lipson
,
Ragini R. Kudchadkar
,
Natalie Miller
,
Lakshmanan Annamalai
,
Sneha Berry
,
Elliot Chartash
,
Adil Daud
,
Steven P. Fling
,
Philip Friedlander
,
Harriet M. Kluger
,
Holbrook E. Kohrt
,
Lisa Lundgren
,
Kim Margolin
,
Alan Mitchell
,
Thomas Olencki
,
Drew M. Pardoll
,
Sunil Reddy
,
Erica Shantha
,
William H. Sharfman
,
Elad Sharon
,
Lynn Shemanski
,
Michi M. Shinohara
,
Joel Sunshine
,
Janis M. Taube
,
John A. Thompson
,
Steven M. Townson
,
Jennifer H. Yearley
,
Suzanne L. Topalian
,
Martin A. Cheever
·
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1056/nejmoa1603702
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1056/nejmoa1603702
BackgroundMerkel-cell carcinoma is an aggressive skin cancer that is linked to exposure to ultraviolet light and the Merkel-cell polyomavirus (MCPyV). Advanced Merkel-cell carcinoma often responds to chemotherapy, but responses are transient. Blocking the programmed death 1 (PD-1) immune inhibitory pathway is of interest, because these tumors often express PD-L1, and MCPyV-specific T cells express PD-1.MethodsIn this multicenter, phase 2, noncontrolled study, we assigned adults with advanced Merkel-cell carcinoma who had received no previous systemic therapy to receive pembrolizumab (anti-PD-1) at a dose of 2 mg per kilogram of body weight every 3 weeks. The primary end point was the objective response rate according to Response Evaluation Criteria in Solid Tumors, version 1.1. Efficacy was correlated with tumor viral status, as assessed by serologic and immunohistochemical testing.ResultsA total of 26 patients received at least one dose of pembrolizumab. The objective response rate among the 25 patients with at least one evaluation during treatment was 56% (95% confidence interval [CI], 35 to 76); 4 patients had a complete response, and 10 had a partial response. With a median follow-up of 33 weeks (range, 7 to 53), relapses occurred in 2 of the 14 patients who had had a response (14%). The response duration ranged from at least 2.2 months to at least 9.7 months. The rate of progression-free survival at 6 months was 67% (95% CI, 49 to 86). A total of 17 of the 26 patients (65%) had virus-positive tumors. The response rate was 62% among patients with MCPyV-positive tumors (10 of 16 patients) and 44% among those with virus-negative tumors (4 of 9 patients). Drug-related grade 3 or 4 adverse events occurred in 15% of the patients.ConclusionsIn this study, first-line therapy with pembrolizumab in patients with advanced Merkel-cell carcinoma was associated with an objective response rate of 56%. Responses were observed in patients with virus-positive tumors and those with virus-negative tumors. (Funded by the National Cancer Institute and Merck; ClinicalTrials.gov number, NCT02267603.).
Related Topics
Concepts
Merkel cell polyomavirus
Merkel cell carcinoma
Pembrolizumab
Medicine
Merkel cell
Internal medicine
Response Evaluation Criteria in Solid Tumors
Oncology
Carcinoma
Cancer
Gastroenterology
Chemotherapy
Phases of clinical research
Immunotherapy
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1056/nejmoa1603702
- https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603702?articleTools=true
- OA Status
- bronze
- Cited By
- 1214
- References
- 42
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2339890238
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2339890238Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1056/nejmoa1603702Digital Object Identifier
- Title
-
PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell CarcinomaWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2016Year of publication
- Publication date
-
2016-04-19Full publication date if available
- Authors
-
Paul Nghiem, Shailender Bhatia, Evan J. Lipson, Ragini R. Kudchadkar, Natalie Miller, Lakshmanan Annamalai, Sneha Berry, Elliot Chartash, Adil Daud, Steven P. Fling, Philip Friedlander, Harriet M. Kluger, Holbrook E. Kohrt, Lisa Lundgren, Kim Margolin, Alan Mitchell, Thomas Olencki, Drew M. Pardoll, Sunil Reddy, Erica Shantha, William H. Sharfman, Elad Sharon, Lynn Shemanski, Michi M. Shinohara, Joel Sunshine, Janis M. Taube, John A. Thompson, Steven M. Townson, Jennifer H. Yearley, Suzanne L. Topalian, Martin A. CheeverList of authors in order
- Landing page
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https://doi.org/10.1056/nejmoa1603702Publisher landing page
- PDF URL
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https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603702?articleTools=trueDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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bronzeOpen access status per OpenAlex
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https://www.nejm.org/doi/pdf/10.1056/NEJMoa1603702?articleTools=trueDirect OA link when available
- Concepts
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Merkel cell polyomavirus, Merkel cell carcinoma, Pembrolizumab, Medicine, Merkel cell, Internal medicine, Response Evaluation Criteria in Solid Tumors, Oncology, Carcinoma, Cancer, Gastroenterology, Chemotherapy, Phases of clinical research, ImmunotherapyTop concepts (fields/topics) attached by OpenAlex
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2025: 64, 2024: 77, 2023: 83, 2022: 101, 2021: 145Per-year citation counts (last 5 years)
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42Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.Response | 104 |
| abstract_inverted_index.advanced | 65, 286 |
| abstract_inverted_index.assessed | 120 |
| abstract_inverted_index.assigned | 62 |
| abstract_inverted_index.complete | 165 |
| abstract_inverted_index.duration | 200 |
| abstract_inverted_index.exposure | 11 |
| abstract_inverted_index.interval | 156 |
| abstract_inverted_index.kilogram | 86 |
| abstract_inverted_index.observed | 300 |
| abstract_inverted_index.occurred | 185, 271 |
| abstract_inverted_index.patients | 129, 144, 162, 191, 234, 245, 284, 302 |
| abstract_inverted_index.previous | 72 |
| abstract_inverted_index.received | 70, 130 |
| abstract_inverted_index.relapses | 184 |
| abstract_inverted_index.responds | 24 |
| abstract_inverted_index.response | 100, 139, 196, 199, 240, 294 |
| abstract_inverted_index.survival | 216 |
| abstract_inverted_index.systemic | 73 |
| abstract_inverted_index.Institute | 316 |
| abstract_inverted_index.Responses | 298 |
| abstract_inverted_index.according | 102 |
| abstract_inverted_index.carcinoma | 1, 22, 67, 288 |
| abstract_inverted_index.follow-up | 176 |
| abstract_inverted_index.interest, | 42 |
| abstract_inverted_index.objective | 99, 138, 293 |
| abstract_inverted_index.patients) | 252 |
| abstract_inverted_index.response, | 166 |
| abstract_inverted_index.response. | 172 |
| abstract_inverted_index.responses | 28 |
| abstract_inverted_index.serologic | 122 |
| abstract_inverted_index.treatment | 151 |
| abstract_inverted_index.Evaluation | 105 |
| abstract_inverted_index.aggressive | 4 |
| abstract_inverted_index.associated | 290 |
| abstract_inverted_index.confidence | 155 |
| abstract_inverted_index.correlated | 114 |
| abstract_inverted_index.evaluation | 149 |
| abstract_inverted_index.first-line | 279 |
| abstract_inverted_index.inhibitory | 38 |
| abstract_inverted_index.patients). | 263 |
| abstract_inverted_index.programmed | 33 |
| abstract_inverted_index.transient. | 30 |
| abstract_inverted_index.(anti-PD-1) | 78 |
| abstract_inverted_index.Merkel-cell | 17, 21, 66, 287 |
| abstract_inverted_index.ultraviolet | 13 |
| abstract_inverted_index.Drug-related | 264 |
| abstract_inverted_index.multicenter, | 56 |
| abstract_inverted_index.polyomavirus | 18 |
| abstract_inverted_index.chemotherapy, | 26 |
| abstract_inverted_index.noncontrolled | 59 |
| abstract_inverted_index.pembrolizumab | 77, 282 |
| abstract_inverted_index.MCPyV-positive | 247 |
| abstract_inverted_index.MCPyV-specific | 50 |
| abstract_inverted_index.NCT02267603.). | 321 |
| abstract_inverted_index.PD-1.MethodsIn | 54 |
| abstract_inverted_index.pembrolizumab. | 136 |
| abstract_inverted_index.virus-negative | 258, 309 |
| abstract_inverted_index.virus-positive | 237, 304 |
| abstract_inverted_index.progression-free | 215 |
| abstract_inverted_index.testing.ResultsA | 125 |
| abstract_inverted_index.ClinicalTrials.gov | 319 |
| abstract_inverted_index.immunohistochemical | 124 |
| abstract_inverted_index.BackgroundMerkel-cell | 0 |
| abstract_inverted_index.patients.ConclusionsIn | 276 |
| cited_by_percentile_year.max | 100 |
| cited_by_percentile_year.min | 96 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 31 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8700000047683716 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.99961987 |
| citation_normalized_percentile.is_in_top_1_percent | True |
| citation_normalized_percentile.is_in_top_10_percent | True |