Universität zu Köln

Armand, Philippe, Engert, Andreas, Younes, Anas, Fanale, Michelle, Santoro, Armando ORCID: 0000-0003-1709-9492, Zinzani, Pier Luigi, Timmerman, John M., Collins, Graham P., Ramchandren, Radhakrishnan, Cohen, Jonathon B., De Boer, Jan Paul, Kuruvilla, John, Savage, Kerry J., Trneny, Marek, Shipp, Margaret A., Kato, Kazunobu, Sumbul, Anne, Farsaci, Benedetto ORCID: 0000-0001-8275-2561 and Ansell, Stephen M. (2018). 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. J. Clin. Oncol., 36 (14). S. 1428 - 1450. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

PurposeGenetic 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.MethodsThis 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)-naive (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.ResultsOverall, 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.ConclusionWith 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Armand, Philippe UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Younes, Anas UNSPECIFIED UNSPECIFIED UNSPECIFIED Fanale, Michelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Santoro, Armando UNSPECIFIED orcid.org/0000-0003-1709-9492 UNSPECIFIED Zinzani, Pier Luigi UNSPECIFIED UNSPECIFIED UNSPECIFIED Timmerman, John M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Collins, Graham P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramchandren, Radhakrishnan UNSPECIFIED UNSPECIFIED UNSPECIFIED Cohen, Jonathon B. UNSPECIFIED UNSPECIFIED UNSPECIFIED De Boer, Jan Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuruvilla, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Savage, Kerry J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Trneny, Marek UNSPECIFIED UNSPECIFIED UNSPECIFIED Shipp, Margaret A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kato, Kazunobu UNSPECIFIED UNSPECIFIED UNSPECIFIED Sumbul, Anne UNSPECIFIED UNSPECIFIED UNSPECIFIED Farsaci, Benedetto UNSPECIFIED orcid.org/0000-0001-8275-2561 UNSPECIFIED Ansell, Stephen M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-186498
DOI:	10.1200/JCO.2017.76.0793
Journal or Publication Title:	J. Clin. Oncol.
Volume:	36
Number:	14
Page Range:	S. 1428 - 1450
Date:	2018
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 RESPONSE CRITERIA; BRENTUXIMAB VEDOTIN; PD-1 BLOCKADE; SOLID TUMORS; PEMBROLIZUMAB; GEMCITABINE; ACTIVATION; EFFICACY; OUTCOMES; LIGAND Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/18649