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J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.

Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial.

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1
Philippe Armand and Margaret A. Shipp, Dana-Farber Cancer Institute, Boston, MA; Andreas Engert, University Hospital of Cologne, Cologne, Germany; Anas Younes, Memorial Sloan Kettering Cancer Center, New York, NY; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Armando Santoro, Humanitas Cancer Center, Humanitas University, Milan; Pier Luigi Zinzani, Institute of Hematology "L. e A. Seràgnoli," University of Bologna, Bologna, Italy; John M. Timmerman, University of California Los Angeles Medical Center, Los Angeles, CA; Graham P. Collins, Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, United Kingdom; Radhakrishnan Ramchandren, Barbara Ann Karmanos Cancer Institute, Detroit, MI; Jonathon B. Cohen, Winship Cancer Institute, Emory University, Atlanta, GA; Jan Paul De Boer, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands, on behalf of Lunenburg Lymphoma Phase I/II Consortium; John Kuruvilla, University of Toronto and Princess Margaret Cancer Centre, Toronto, Ontario; Kerry J. Savage, BC Cancer Agency, Vancouver, British Columbia, Canada; Marek Trneny, Charles University, General Hospital in Prague, Prague, Czech Republic; Kazunobu Kato, Anne Sumbul, and Benedetto Farsaci, Bristol-Myers Squibb, Princeton, NJ; and Stephen M. Ansell, Mayo Clinic, Rochester, MN.

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Abstract

Purpose Genetic alterations causing overexpression of programmed death-1 ligands are near universal in classic Hodgkin lymphoma (cHL). Nivolumab, a programmed death-1 checkpoint inhibitor, demonstrated efficacy in relapsed/refractory cHL after autologous hematopoietic cell transplantation (auto-HCT) in initial analyses of one of three cohorts from the CheckMate 205 study of nivolumab for cHL. Here, we assess safety and efficacy after extended follow-up of all three cohorts. Methods This multicenter, single-arm, phase II study enrolled patients with relapsed/refractory cHL after auto-HCT treatment failure into cohorts by treatment history: brentuximab vedotin (BV)-naïve (cohort A), BV received after auto-HCT (cohort B), and BV received before and/or after auto-HCT (cohort C). All patients received nivolumab 3 mg/kg every 2 weeks until disease progression/unacceptable toxicity. The primary end point was objective response rate per independent radiology review committee. Results Overall, 243 patients were treated; 63 in cohort A, 80 in cohort B, and 100 in cohort C. After a median follow-up of 18 months, 40% continued to receive treatment. The objective response rate was 69% (95% CI, 63% to 75%) overall and 65% to 73% in each cohort. Overall, the median duration of response was 16.6 months (95% CI, 13.2 to 20.3 months), and median progression-free survival was 14.7 months (95% CI, 11.3 to 18.5 months). Of 70 patients treated past conventional disease progression, 61% of those evaluable had stable or further reduced target tumor burdens. The most common grade 3 to 4 drug-related adverse events were lipase increases (5%), neutropenia (3%), and ALT increases (3%). Twenty-nine deaths occurred; none were considered treatment related. Conclusion With extended follow-up, responses to nivolumab were frequent and durable. Nivolumab seems to be associated with a favorable safety profile and long-term benefits across a broad spectrum of patients with relapsed/refractory cHL.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02181738.

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PMID:
29584546
PMCID:
PMC6075855
DOI:
10.1200/JCO.2017.76.0793
[Indexed for MEDLINE]
Free PMC Article

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