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Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma
City Hope Natl Med Ctr, Natl Med Ctr, Duarte, CA USA.
Univ Bologna, Bologna, Italy.
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.
Dana Farber Canc Inst, Boston, MA 02115 USA.
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2017 (English)In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 35, no 19, p. 2125-2132Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2017. Vol. 35, no 19, p. 2125-2132
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Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-361232DOI: 10.1200/JCO.2016.72.1316ISI: 000404378800007PubMedID: 28441111OAI: oai:DiVA.org:uu-361232DiVA, id: diva2:1251216
Available from: 2018-09-26 Created: 2018-09-26 Last updated: 2018-09-26Bibliographically approved

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