Universität zu Köln

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 and Moskowitz, Craig H. (2017). Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. J. Clin. Oncol., 35 (19). S. 2125 - 2135. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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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. (C) 2017 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Chen, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Zinzani, Pier Luigi UNSPECIFIED UNSPECIFIED UNSPECIFIED Fanale, Michelle A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Armand, Philippe UNSPECIFIED UNSPECIFIED UNSPECIFIED Johnson, Nathalie A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brice, Pauline UNSPECIFIED UNSPECIFIED UNSPECIFIED Radford, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Ribrag, Vincent UNSPECIFIED UNSPECIFIED UNSPECIFIED Molin, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Vassilakopoulos, Theodoros P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tomita, Akihiro UNSPECIFIED UNSPECIFIED UNSPECIFIED von Tresckow, Bastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Shipp, Margaret A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Yinghua UNSPECIFIED UNSPECIFIED UNSPECIFIED Ricart, Alejandro D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Balakumaran, Arun UNSPECIFIED UNSPECIFIED UNSPECIFIED Moskowitz, Craig H. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-226672
DOI:	10.1200/JCO.2016.72.1316
Journal or Publication Title:	J. Clin. Oncol.
Volume:	35
Number:	19
Page Range:	S. 2125 - 2135
Date:	2017
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STEM-CELL TRANSPLANTATION; BRENTUXIMAB VEDOTIN; THERAPY; FAILURE; BIOLOGY; TRIAL; PD-L1 Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22667