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Cited by 3,392

The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.

Safety and Tumor Responses with Lambrolizumab (Anti–PD-1) in Melanoma

Open access
Hamid, Omid, Robert, Caroline, Daud, Adil, Hodi, F. Stephen, Hwu, Wen-Jen, Kefford, Richard, Wolchok, Jedd D., Hersey, Peter, Joseph, Richard W., Weber, Jeffrey S., Dronca, Roxana, Gangadhar, Tara C., Patnaik, Amita, Zarour, Hassane, Joshua, Anthony M., Gergich, Kevin, Elassaiss-Schaap, Jeroen, Algazi, Alain, Mateus, Christine, Boasberg, Peter, Tumeh, Paul C., Chmielowski, Bartosz, Ebbinghaus, Scot W., Li, Xiaoyun Nicole, Kang, S. Peter, Ribas, Antoni·2013·New England Journal of Medicine
DOI 10.1056/nejmoa1305133
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Abstract

BACKGROUND: The programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma. METHODS: We administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks. RESULTS: A total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months. CONCLUSIONS: In patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.).

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Research works printed but not linked: 9

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  2. 10.1056/NEJMe1205943 · DOI · Paper page
  3. 10.1200/JCO.2009.26.7609 · DOI · Paper page
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  9. 10.1126/science.271.5256.1734 · DOI · Paper page

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Items 101–159 of 159

Metadata

Authors
Hamid, O., Robert, C., Daud, A., Hodi, F. S., Hwu, W.-J., Kefford, R., Wolchok, J. D., Hersey, P., Joseph, R. W., Weber, J. S., Dronca, R., Gangadhar, T. C., Patnaik, A., Zarour, H., Joshua, A. M., Gergich, K., Elassaiss-Schaap, J., Algazi, A., Mateus, C., Boasberg, P., Tumeh, P. C., Chmielowski, B., Ebbinghaus, S. W., Li, X. N., Kang, S. P., & Ribas, A.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2013-07-11
Volume
369
Issue
2
Pages
134-144
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1305133
OpenAlex
W2118982164
Cited by
3,392
References
7
FWCI
235.25
Type
journal article
Language
en
Open access
bronze

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