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PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Open access
Migden, Michael R., Rischin, Danny, Schmults, Chrysalyne D., Guminski, Alexander, Hauschild, Axel, Lewis, Karl D., Chung, Christine H., Hernandez-Aya, Leonel, Lim, Annette M., Chang, Anne Lynn S., Rabinowits, Guilherme, Thai, Alesha A., Dunn, Lara A., Hughes, Brett G.M., Khushalani, Nikhil I., Modi, Badri, Schadendorf, Dirk, Gao, Bo, Seebach, Frank, Li, Siyu, Li, Jingjin, Mathias, Melissa, Booth, Jocelyn, Mohan, Kosalai, Stankevich, Elizabeth, Babiker, Hani M., Brana, Irene, Gil-Martin, Marta, Homsi, Jade, Johnson, Melissa L., Moreno, Victor, Niu, Jiaxin, Owonikoko, Taofeek K., Papadopoulos, Kyriakos P., Yancopoulos, George D., Lowy, Israel, Fury, Matthew G.·2018·New England Journal of Medicine

Abstract

BACKGROUND: No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma. METHODS: We report the results of the phase 1 study of cemiplimab for expansion cohorts of patients with locally advanced or metastatic cutaneous squamous-cell carcinoma, as well as the results of the pivotal phase 2 study for a cohort of patients with metastatic disease (metastatic-disease cohort). In both studies, the patients received an intravenous dose of cemiplimab (3 mg per kilogram of body weight) every 2 weeks and were assessed for a response every 8 weeks. In the phase 2 study, the primary end point was the response rate, as assessed by independent central review. RESULTS: In the expansion cohorts of the phase 1 study, a response to cemiplimab was observed in 13 of 26 patients (50%; 95% confidence interval [CI], 30 to 70). In the metastatic-disease cohort of the phase 2 study, a response was observed in 28 of 59 patients (47%; 95% CI, 34 to 61). The median follow-up was 7.9 months in the metastatic-disease cohort of the phase 2 study. Among the 28 patients who had a response, the duration of response exceeded 6 months in 57%, and 82% continued to have a response and to receive cemiplimab at the time of data cutoff. Adverse events that occurred in at least 15% of the patients in the metastatic-disease cohort of the phase 2 study were diarrhea, fatigue, nausea, constipation, and rash; 7% of the patients discontinued treatment because of an adverse event. CONCLUSIONS: Among patients with advanced cutaneous squamous-cell carcinoma, cemiplimab induced a response in approximately half the patients and was associated with adverse events that usually occur with immune checkpoint inhibitors. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT02383212 and NCT02760498 .).

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Metadata

Authors
Migden, M. R., Rischin, D., Schmults, C. D., Guminski, A., Hauschild, A., Lewis, K. D., Chung, C. H., Hernandez-Aya, L., Lim, A. M., Chang, A. L. S., Rabinowits, G., Thai, A. A., Dunn, L. A., Hughes, B. G. M., Khushalani, N. I., Modi, B., Schadendorf, D., Gao, B., Seebach, F., Li, S., Li, J., Mathias, M., Booth, J., Mohan, K., Stankevich, E., Babiker, H. M., Brana, I., Gil-Martin, M., Homsi, J., Johnson, M. L., Moreno, V., Niu, J., Owonikoko, T. K., Papadopoulos, K. P., Yancopoulos, G. D., Lowy, I., & Fury, M. G.
Venue
New England Journal of Medicine
Published
2018-07-26
Volume
379
Issue
4
Pages
341-351
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2805968856
Cited by
1,411
References
8
FWCI
110.45
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. https://app.cochat.ai/papers/10.1056/nejmoa1805131
The paper
Migden, M. R., Rischin, D., Schmults, C. D., Guminski, A., Hauschild, A., Lewis, K. D., Chung, C. H., Hernandez-Aya, L., Lim, A. M., Chang, A. L. S., Rabinowits, G., Thai, A. A., Dunn, L. A., Hughes, B. G. M., Khushalani, N. I., Modi, B., Schadendorf, D., Gao, B., Seebach, F., . . . Fury, M. G. (2018). PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1805131

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.