Patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) for whom autologous hematopoietic cell transplantation (auto-HCT) had failed experienced frequent and durable responses to nivolumab in the phase 2 CheckMate 205 trial. We present updated results (median follow-up, ∼5 years). Patients with R/R cHL who were brentuximab vedotin (BV)-naive (cohort A), received BV after auto-HCT (cohort B), or received BV before and/or after auto-HCT (cohort C) were administered with nivolumab 3 mg/kg IV every 2 weeks until progression or unacceptable toxicity. Patients in cohort C with complete remission (CR) for 1 year could discontinue nivolumab and resume upon relapse. Among 243 patients (cohort A, n = 63; B, n = 80; and C, n = 100), the objective response rate (ORR) was 71.2% (95% confidence interval [CI], 65.1-76.8); the CR rate was 21.4% (95% CI, 16.4-27.1). Median duration of response, CR, and partial remission were 18.2 (95% CI, 14.7-26.1), 30.3, and 13.5 months, respectively. Median progression-free survival was 15.1 months (95% CI, 11.3-18.5). Median overall survival (OS) was not reached; OS at 5 years was 71.4% (95% CI, 64.8-77.1). In cohort C, all 3 patients who discontinued in CR and were subsequently re-treated achieved objective response. No new or unexpected safety signals were identified. This 5-year follow-up of CheckMate 205 demonstrated favorable OS and confirmed efficacy and safety of nivolumab in R/R cHL after auto-HCT failure. Results suggest patients may discontinue treatment after persistent CR and reinitiate upon progression. This trial was registered at www.clinicaltrials.gov as #NCT02181713.

BC Cancer Vancouver BC Canada

Bristol Myers Squibb Boudry Switzerland

Bristol Myers Squibb Princeton NJ

Charles University Prague Prague Czech Republic

Churchill Hospital Oxford United Kingdom

Dana Farber Cancer Institute Boston MA

Humanitas University Pieve Emanuele Milan Italy and IRCCS Humanitas Research Hospital Humanitas Cancer Center Rozzano Milan Italy

Innsbruck Medical University and Sydena GmbH Connect to Cure Innsbruck Austria

IRCCS Azienda Ospedaliero Universitaria di Bologna Instituto di Ematologia Seràgnoli and Università di Bologna Bologna Italy

Mayo Clinic Rochester MN

Medical University of Vienna Vienna Austria

Memorial Sloan Kettering Cancer Center New York NY

Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital Amsterdam The Netherlands

Princess Margaret Cancer Centre Toronto ON Canada

University Hospital Puerta de Hierro Majadahonda Spain

University of Cologne Cologne Germany and Center for Integrated Oncology Aachen Bonn Duesseldorf Bonn Germany

University of Texas MD Anderson Cancer Center Houston TX

Winship Cancer Institute Atlanta GA

Blood Adv. 2024 Feb 27;8(4):829-831. doi: 10.1182/bloodadvances.2023012353. PubMed

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ClinicalTrials.gov
NCT02181713