Phase II study of the efficacy and safety of pembrolizumab for relapsed/refractory classic Hodgkin lymphoma Journal Article


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.; for the KEYNOTE-087 Investigators
Article Title: Phase II study of the efficacy and safety of pembrolizumab for relapsed/refractory classic Hodgkin lymphoma
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. © 2017 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 35
Issue: 19
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2017-07-01
Start Page: 2125
End Page: 2132
Language: English
DOI: 10.1200/jco.2016.72.1316
PROVIDER: scopus
PUBMED: 28441111
PMCID: PMC5791843
DOI/URL:
Notes: Article -- Export Date: 2 August 2017 -- Source: Scopus
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MSK Authors
  1. Craig Moskowitz
    374 Moskowitz