دورية أكاديمية
Nivolumab for relapsed/refractory classical Hodgkin lymphoma: 5-year survival from the pivotal phase 2 CheckMate 205 study.
العنوان: | Nivolumab for relapsed/refractory classical Hodgkin lymphoma: 5-year survival from the pivotal phase 2 CheckMate 205 study. |
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المؤلفون: | Ansell SM; Mayo Clinic, Rochester, MN., Bröckelmann PJ; University of Cologne, Cologne, Germany and Center for Integrated Oncology Aachen Bonn Duesseldorf, Bonn, Germany., von Keudell G; Memorial Sloan Kettering Cancer Center, New York, NY., Lee HJ; University of Texas MD Anderson Cancer Center, Houston, TX., Santoro A; Humanitas University, Pieve Emanuele, Milan, Italy and IRCCS Humanitas Research Hospital, Humanitas Cancer Center, Rozzano, Milan, Italy., Zinzani PL; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Instituto di Ematologia 'Seràgnoli' and Università di Bologna, Bologna, Italy., Collins GP; Churchill Hospital, Oxford, United Kingdom., Cohen JB; Winship Cancer Institute, Atlanta, GA., de Boer JP; Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Kuruvilla J; Princess Margaret Cancer Centre, Toronto, ON, Canada., Savage KJ; BC Cancer, Vancouver, BC, Canada., Trněný M; Charles University in Prague, Prague, Czech Republic., Provencio M; University Hospital Puerta de Hierro, Majadahonda, Spain., Jäger U; Medical University of Vienna, Vienna, Austria., Willenbacher W; Innsbruck Medical University and Sydena GmbH, Connect to Cure, Innsbruck, Austria., Wen R; Bristol Myers Squibb, Princeton, NJ., Akyol A; Bristol Myers Squibb, Princeton, NJ., Mikita-Geoffroy J; Bristol Myers Squibb, Boudry, Switzerland., Shipp MA; Dana-Farber Cancer Institute, Boston, MA., Engert A; University of Cologne, Cologne, Germany and Center for Integrated Oncology Aachen Bonn Duesseldorf, Bonn, Germany., Armand P; Dana-Farber Cancer Institute, Boston, MA. |
المصدر: | Blood advances [Blood Adv] 2023 Oct 24; Vol. 7 (20), pp. 6266-6274. |
نوع المنشور: | Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: American Society of Hematology Country of Publication: United States NLM ID: 101698425 Publication Model: Print Cited Medium: Internet ISSN: 2473-9537 (Electronic) Linking ISSN: 24739529 NLM ISO Abbreviation: Blood Adv Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Washington, DC : American Society of Hematology, [2016]- |
مواضيع طبية MeSH: | Hodgkin Disease*/pathology , Immunoconjugates*, Humans ; Nivolumab/therapeutic use ; Neoplasm Recurrence, Local/drug therapy ; Brentuximab Vedotin ; Chronic Disease |
مستخلص: | 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. (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.) |
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معلومات مُعتمدة: | P30 CA008748 United States CA NCI NIH HHS |
سلسلة جزيئية: | ClinicalTrials.gov NCT02181713 |
المشرفين على المادة: | 31YO63LBSN (Nivolumab) 7XL5ISS668 (Brentuximab Vedotin) 0 (Immunoconjugates) |
تواريخ الأحداث: | Date Created: 20230802 Date Completed: 20240108 Latest Revision: 20240110 |
رمز التحديث: | 20240110 |
مُعرف محوري في PubMed: | PMC10589773 |
DOI: | 10.1182/bloodadvances.2023010334 |
PMID: | 37530622 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2473-9537 |
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DOI: | 10.1182/bloodadvances.2023010334 |