Cited by 1,258Polyomavirus and related diseasesCancer Immunotherapy and BiomarkersNonmelanoma Skin Cancer Studies

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PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma

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Nghiem, Paul T., Bhatia, Shailender, Lipson, Evan J., Kudchadkar, Ragini R., Miller, Natalie J., Annamalai, Lakshmanan, Berry, Sneha, Chartash, Elliot K., Daud, Adil, Fling, Steven P., Friedlander, Philip A., Kluger, Harriet M., Kohrt, Holbrook E., Lundgren, Lisa, Margolin, Kim, Mitchell, Alan, Olencki, Thomas, Pardoll, Drew M., Reddy, Sunil A., Shantha, Erica M., Sharfman, William H., Sharon, Elad, Shemanski, Lynn R., Shinohara, Michi M., Sunshine, Joel C., Taube, Janis M., Thompson, John A., Townson, Steven M., Yearley, Jennifer H., Topalian, Suzanne L., Cheever, Martin A.·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1603702PMC PMC4927341

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Abstract

BACKGROUND: Merkel-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. METHODS: In 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. RESULTS: A 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. CONCLUSIONS: In 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.).

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Authors: Nghiem, P. T., Bhatia, S., Lipson, E. J., Kudchadkar, R. R., Miller, N. J., Annamalai, L., Berry, S., Chartash, E. K., Daud, A., Fling, S. P., Friedlander, P. A., Kluger, H. M., Kohrt, H. E., Lundgren, L., Margolin, K., Mitchell, A., Olencki, T., Pardoll, D. M., Reddy, S. A., Shantha, E. M., Sharfman, W. H., Sharon, E., Shemanski, L. R., Shinohara, M. M., Sunshine, J. C., Taube, J. M., Thompson, J. A., Townson, S. M., Yearley, J. H., Topalian, S. L., & Cheever, M. A.
Affiliations: Johns Hopkins University (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Mount Sinai Hospital (US)
ORCID: Nghiem, Paul T.
Bhatia, Shailender
Lipson, Evan J.
Kudchadkar, Ragini R.
Miller, Natalie J.
Berry, Sneha
Chartash, Elliot K.
Daud, Adil
Fling, Steven P.
Friedlander, Philip A.
Kluger, Harriet M.
Lundgren, Lisa
Margolin, Kim
Pardoll, Drew M.
Reddy, Sunil A.
Sharfman, William H.
Sharon, Elad
Shinohara, Michi M.
Sunshine, Joel C.
Taube, Janis M.
Thompson, John A.
Topalian, Suzanne L.
Cheever, Martin A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-06-30
Volume: 374
Issue: 26
Pages: 2542-2552
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1603702
PMC: PMC4927341
OpenAlex: W2339890238
Cited by: 1,258
References: 42
Citations by year: 2026: 40 · 2025: 68 · 2024: 76 · 2023: 86 · 2022: 104 · 2021: 141 · 2020: 166 · 2019: 172 · 2018: 187 · 2017: 174 · 2016: 40
FWCI: 103.02
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: National Institutes of Health (5u01ca154967-06)
National Cancer Institute (U01-CA-154967, R01CA162522, 1U01CA154967, K24CA139052, UM1CA154967, R01CA142779, P30CA006973)
National Institute of General Medical Sciences (T32GM007266)
Topics: Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
Keywords: Merkel cell carcinoma, pembrolizumab, anti-PD-1 therapy, immune checkpoint inhibitors, Merkel cell polyomavirus, PD-L1 expression, first-line therapy, objective response rate, progression-free survival, cutaneous squamous cell carcinoma, immune-related adverse events, treatment-related adverse events, treatment duration, drug safety and efficacy
MeSH terms: Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neoplasm Staging, Recurrence, Skin Neoplasms, Carcinoma, Merkel Cell, Disease-Free Survival, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized

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