PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma
Identifieur interne : 000D18 ( Main/Exploration ); précédent : 000D17; suivant : 000D19PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma
Auteurs : Paul T. Nghiem ; Shailender Bhatia ; Evan J. Lipson ; Ragini R. Kudchadkar ; Natalie J. Miller ; Lakshmanan Annamalai ; Sneha Berry ; Elliot K. Chartash ; Adil Daud ; Steven P. Fling ; Philip A. Friedlander ; Harriet M. Kluger ; Holbrook E. Kohrt ; Lisa Lundgren ; Kim Margolin ; Alan Mitchell ; Thomas Olencki ; Drew M. Pardoll ; Sunil A. Reddy ; Erica M. Shantha ; William H. Sharfman ; Elad Sharon ; Lynn R. Shemanski ; Michi M. Shinohara ; Joel C. Sunshine ; Janis M. Taube ; John A. Thompson ; Steven M. Townson ; Jennifer H. Yearley ; Suzanne L. Topalian ; Martin A. CheeverSource :
- The New England journal of medicine [ 0028-4793 ] ; 2016.
Abstract
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.
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.
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.
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;
Url:
DOI: 10.1056/NEJMoa1603702
PubMed: 27093365
PubMed Central: 4927341
Affiliations:
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Miller</name></author><author><name sortKey="Annamalai, Lakshmanan" sort="Annamalai, Lakshmanan" uniqKey="Annamalai L" first="Lakshmanan" last="Annamalai">Lakshmanan Annamalai</name></author><author><name sortKey="Berry, Sneha" sort="Berry, Sneha" uniqKey="Berry S" first="Sneha" last="Berry">Sneha Berry</name></author><author><name sortKey="Chartash, Elliot K" sort="Chartash, Elliot K" uniqKey="Chartash E" first="Elliot K." last="Chartash">Elliot K. Chartash</name></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name></author><author><name sortKey="Fling, Steven P" sort="Fling, Steven P" uniqKey="Fling S" first="Steven P." last="Fling">Steven P. Fling</name></author><author><name sortKey="Friedlander, Philip A" sort="Friedlander, Philip A" uniqKey="Friedlander P" first="Philip A." last="Friedlander">Philip A. 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Nghiem</name></author><author><name sortKey="Bhatia, Shailender" sort="Bhatia, Shailender" uniqKey="Bhatia S" first="Shailender" last="Bhatia">Shailender Bhatia</name></author><author><name sortKey="Lipson, Evan J" sort="Lipson, Evan J" uniqKey="Lipson E" first="Evan J." last="Lipson">Evan J. Lipson</name></author><author><name sortKey="Kudchadkar, Ragini R" sort="Kudchadkar, Ragini R" uniqKey="Kudchadkar R" first="Ragini R." last="Kudchadkar">Ragini R. Kudchadkar</name></author><author><name sortKey="Miller, Natalie J" sort="Miller, Natalie J" uniqKey="Miller N" first="Natalie J." last="Miller">Natalie J. Miller</name></author><author><name sortKey="Annamalai, Lakshmanan" sort="Annamalai, Lakshmanan" uniqKey="Annamalai L" first="Lakshmanan" last="Annamalai">Lakshmanan Annamalai</name></author><author><name sortKey="Berry, Sneha" sort="Berry, Sneha" uniqKey="Berry S" first="Sneha" last="Berry">Sneha Berry</name></author><author><name sortKey="Chartash, Elliot K" sort="Chartash, Elliot K" uniqKey="Chartash E" first="Elliot K." last="Chartash">Elliot K. Chartash</name></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name></author><author><name sortKey="Fling, Steven P" sort="Fling, Steven P" uniqKey="Fling S" first="Steven P." last="Fling">Steven P. Fling</name></author><author><name sortKey="Friedlander, Philip A" sort="Friedlander, Philip A" uniqKey="Friedlander P" first="Philip A." last="Friedlander">Philip A. Friedlander</name></author><author><name sortKey="Kluger, Harriet M" sort="Kluger, Harriet M" uniqKey="Kluger H" first="Harriet M." last="Kluger">Harriet M. Kluger</name></author><author><name sortKey="Kohrt, Holbrook E" sort="Kohrt, Holbrook E" uniqKey="Kohrt H" first="Holbrook E." last="Kohrt">Holbrook E. Kohrt</name></author><author><name sortKey="Lundgren, Lisa" sort="Lundgren, Lisa" uniqKey="Lundgren L" first="Lisa" last="Lundgren">Lisa Lundgren</name></author><author><name sortKey="Margolin, Kim" sort="Margolin, Kim" uniqKey="Margolin K" first="Kim" last="Margolin">Kim Margolin</name></author><author><name sortKey="Mitchell, Alan" sort="Mitchell, Alan" uniqKey="Mitchell A" first="Alan" last="Mitchell">Alan Mitchell</name></author><author><name sortKey="Olencki, Thomas" sort="Olencki, Thomas" uniqKey="Olencki T" first="Thomas" last="Olencki">Thomas Olencki</name></author><author><name sortKey="Pardoll, Drew M" sort="Pardoll, Drew M" uniqKey="Pardoll D" first="Drew M." last="Pardoll">Drew M. Pardoll</name></author><author><name sortKey="Reddy, Sunil A" sort="Reddy, Sunil A" uniqKey="Reddy S" first="Sunil A." last="Reddy">Sunil A. Reddy</name></author><author><name sortKey="Shantha, Erica M" sort="Shantha, Erica M" uniqKey="Shantha E" first="Erica M." last="Shantha">Erica M. Shantha</name></author><author><name sortKey="Sharfman, William H" sort="Sharfman, William H" uniqKey="Sharfman W" first="William H." last="Sharfman">William H. Sharfman</name></author><author><name sortKey="Sharon, Elad" sort="Sharon, Elad" uniqKey="Sharon E" first="Elad" last="Sharon">Elad Sharon</name></author><author><name sortKey="Shemanski, Lynn R" sort="Shemanski, Lynn R" uniqKey="Shemanski L" first="Lynn R." last="Shemanski">Lynn R. Shemanski</name></author><author><name sortKey="Shinohara, Michi M" sort="Shinohara, Michi M" uniqKey="Shinohara M" first="Michi M." last="Shinohara">Michi M. Shinohara</name></author><author><name sortKey="Sunshine, Joel C" sort="Sunshine, Joel C" uniqKey="Sunshine J" first="Joel C." last="Sunshine">Joel C. Sunshine</name></author><author><name sortKey="Taube, Janis M" sort="Taube, Janis M" uniqKey="Taube J" first="Janis M." last="Taube">Janis M. Taube</name></author><author><name sortKey="Thompson, John A" sort="Thompson, John A" uniqKey="Thompson J" first="John A." last="Thompson">John A. Thompson</name></author><author><name sortKey="Townson, Steven M" sort="Townson, Steven M" uniqKey="Townson S" first="Steven M." last="Townson">Steven M. Townson</name></author><author><name sortKey="Yearley, Jennifer H" sort="Yearley, Jennifer H" uniqKey="Yearley J" first="Jennifer H." last="Yearley">Jennifer H. Yearley</name></author><author><name sortKey="Topalian, Suzanne L" sort="Topalian, Suzanne L" uniqKey="Topalian S" first="Suzanne L." last="Topalian">Suzanne L. Topalian</name></author><author><name sortKey="Cheever, Martin A" sort="Cheever, Martin A" uniqKey="Cheever M" first="Martin A." last="Cheever">Martin A. Cheever</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="ISSN">0028-4793</idno><idno type="eISSN">1533-4406</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>BACKGROUND</title><p id="P4">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.</p></sec><sec id="S2"><title>METHODS</title><p id="P5">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.</p></sec><sec id="S3"><title>RESULTS</title><p id="P6">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.</p></sec><sec id="S4"><title>CONCLUSIONS</title><p id="P7">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; <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> number, NCT02267603.)</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Annamalai, Lakshmanan" sort="Annamalai, Lakshmanan" uniqKey="Annamalai L" first="Lakshmanan" last="Annamalai">Lakshmanan Annamalai</name><name sortKey="Berry, Sneha" sort="Berry, Sneha" uniqKey="Berry S" first="Sneha" last="Berry">Sneha Berry</name><name sortKey="Bhatia, Shailender" sort="Bhatia, Shailender" uniqKey="Bhatia S" first="Shailender" last="Bhatia">Shailender Bhatia</name><name sortKey="Chartash, Elliot K" sort="Chartash, Elliot K" uniqKey="Chartash E" first="Elliot K." last="Chartash">Elliot K. Chartash</name><name sortKey="Cheever, Martin A" sort="Cheever, Martin A" uniqKey="Cheever M" first="Martin A." last="Cheever">Martin A. Cheever</name><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><name sortKey="Fling, Steven P" sort="Fling, Steven P" uniqKey="Fling S" first="Steven P." last="Fling">Steven P. Fling</name><name sortKey="Friedlander, Philip A" sort="Friedlander, Philip A" uniqKey="Friedlander P" first="Philip A." last="Friedlander">Philip A. Friedlander</name><name sortKey="Kluger, Harriet M" sort="Kluger, Harriet M" uniqKey="Kluger H" first="Harriet M." last="Kluger">Harriet M. Kluger</name><name sortKey="Kohrt, Holbrook E" sort="Kohrt, Holbrook E" uniqKey="Kohrt H" first="Holbrook E." last="Kohrt">Holbrook E. Kohrt</name><name sortKey="Kudchadkar, Ragini R" sort="Kudchadkar, Ragini R" uniqKey="Kudchadkar R" first="Ragini R." last="Kudchadkar">Ragini R. Kudchadkar</name><name sortKey="Lipson, Evan J" sort="Lipson, Evan J" uniqKey="Lipson E" first="Evan J." last="Lipson">Evan J. Lipson</name><name sortKey="Lundgren, Lisa" sort="Lundgren, Lisa" uniqKey="Lundgren L" first="Lisa" last="Lundgren">Lisa Lundgren</name><name sortKey="Margolin, Kim" sort="Margolin, Kim" uniqKey="Margolin K" first="Kim" last="Margolin">Kim Margolin</name><name sortKey="Miller, Natalie J" sort="Miller, Natalie J" uniqKey="Miller N" first="Natalie J." last="Miller">Natalie J. Miller</name><name sortKey="Mitchell, Alan" sort="Mitchell, Alan" uniqKey="Mitchell A" first="Alan" last="Mitchell">Alan Mitchell</name><name sortKey="Nghiem, Paul T" sort="Nghiem, Paul T" uniqKey="Nghiem P" first="Paul T." last="Nghiem">Paul T. Nghiem</name><name sortKey="Olencki, Thomas" sort="Olencki, Thomas" uniqKey="Olencki T" first="Thomas" last="Olencki">Thomas Olencki</name><name sortKey="Pardoll, Drew M" sort="Pardoll, Drew M" uniqKey="Pardoll D" first="Drew M." last="Pardoll">Drew M. Pardoll</name><name sortKey="Reddy, Sunil A" sort="Reddy, Sunil A" uniqKey="Reddy S" first="Sunil A." last="Reddy">Sunil A. Reddy</name><name sortKey="Shantha, Erica M" sort="Shantha, Erica M" uniqKey="Shantha E" first="Erica M." last="Shantha">Erica M. Shantha</name><name sortKey="Sharfman, William H" sort="Sharfman, William H" uniqKey="Sharfman W" first="William H." last="Sharfman">William H. Sharfman</name><name sortKey="Sharon, Elad" sort="Sharon, Elad" uniqKey="Sharon E" first="Elad" last="Sharon">Elad Sharon</name><name sortKey="Shemanski, Lynn R" sort="Shemanski, Lynn R" uniqKey="Shemanski L" first="Lynn R." last="Shemanski">Lynn R. Shemanski</name><name sortKey="Shinohara, Michi M" sort="Shinohara, Michi M" uniqKey="Shinohara M" first="Michi M." last="Shinohara">Michi M. Shinohara</name><name sortKey="Sunshine, Joel C" sort="Sunshine, Joel C" uniqKey="Sunshine J" first="Joel C." last="Sunshine">Joel C. Sunshine</name><name sortKey="Taube, Janis M" sort="Taube, Janis M" uniqKey="Taube J" first="Janis M." last="Taube">Janis M. Taube</name><name sortKey="Thompson, John A" sort="Thompson, John A" uniqKey="Thompson J" first="John A." last="Thompson">John A. Thompson</name><name sortKey="Topalian, Suzanne L" sort="Topalian, Suzanne L" uniqKey="Topalian S" first="Suzanne L." last="Topalian">Suzanne L. Topalian</name><name sortKey="Townson, Steven M" sort="Townson, Steven M" uniqKey="Townson S" first="Steven M." last="Townson">Steven M. Townson</name><name sortKey="Yearley, Jennifer H" sort="Yearley, Jennifer H" uniqKey="Yearley J" first="Jennifer H." last="Yearley">Jennifer H. Yearley</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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