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Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma

Open access
Chen, Robert, Zinzani, Pier Luigi, Fanale, Michelle A., Armand, Philippe, Johnson, Nathalie A., Brice, Pauline, Radford, John, Ribrag, Vincent, Molin, Daniel, Vassilakopoulos, Theodoros P., Tomita, Akihiro, von Tresckow, Bastian, Shipp, Margaret A., Zhang, Yinghua, Ricart, Alejandro D., Balakumaran, Arun, Moskowitz, Craig H., for the KEYNOTE-087·2017·Journal of Clinical Oncology

Abstract

Purpose: Hodgkin Reed-Sternberg cells harbor alterations in chromosome 9p24.1, leading to overexpression of programmed death-ligand 1 (PD-L1) and PD-L2. Pembrolizumab, a programmed death 1–blocking antibody, demonstrated a high overall response rate (ORR) in patients with relapsed or refractory classic Hodgkin lymphoma (rrHL) in phase I testing. Methods: KEYNOTE-087 ( ClinicalTrials.gov identifier, NCT02453594) was a single-arm phase II study of pembrolizumab in three cohorts of patients with rrHL, defined on the basis of lymphoma progression after (1) autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV); (2) salvage chemotherapy and BV, and thus, ineligible for ASCT because of chemoresistant disease; and (3) ASCT, but without BV after transplantation. Patients received pembrolizumab 200 mg once every 3 weeks. Response was assessed every 12 weeks. The primary end points were ORR by central review and safety. Results: A total of 210 patients were enrolled and treated (69 in cohort 1, 81 in cohort 2, and 60 in cohort 3). At the time of analysis, patients received a median of 13 treatment cycles. Per central review, the ORR was 69.0% (95% CI, 62.3% to 75.2%), and the complete response rate was 22.4% (95% CI, 16.9% to 28.6%). By cohort, ORRs were 73.9% for cohort 1, 64.2% for cohort 2, and 70.0% for cohort 3. Thirty-one patients had a response ≥ 6 months. The safety profile was largely consistent with previous pembrolizumab studies. Conclusion: Pembrolizumab was associated with high response rates and an acceptable safety profile in patients with rrHL, offering a new treatment paradigm for this disease.

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Metadata

Authors
Chen, R., Zinzani, P. L., Fanale, M. A., Armand, P., Johnson, N. A., Brice, P., Radford, J., Ribrag, V., Molin, D., Vassilakopoulos, T. P., Tomita, A., von Tresckow, B., Shipp, M. A., Zhang, Y., Ricart, A. D., Balakumaran, A., Moskowitz, C. H., & KEYNOTE-087, F. T.
Venue
Journal of Clinical Oncology
Published
2017-07-01
Volume
35
Issue
19
Pages
2125-2132
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2609973112
Cited by
989
References
11
FWCI
100.87
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. https://app.cochat.ai/papers/10.1200/jco.2016.72.1316
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Chen, R., Zinzani, P. L., Fanale, M. A., Armand, P., Johnson, N. A., Brice, P., Radford, J., Ribrag, V., Molin, D., Vassilakopoulos, T. P., Tomita, A., von Tresckow, B., Shipp, M. A., Zhang, Y., Ricart, A. D., Balakumaran, A., Moskowitz, C. H., & KEYNOTE-087, F. T. (2017). Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.72.1316

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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.