Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma

We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years. Median overall...

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Bibliographic Details
Published in:Blood Vol. 125; no. 8; p. 1236
Main Authors: Gopal, Ajay K, Chen, Robert, Smith, Scott E, Ansell, Stephen M, Rosenblatt, Joseph D, Savage, Kerry J, Connors, Joseph M, Engert, Andreas, Larsen, Emily K, Chi, Xuedong, Sievers, Eric L, Younes, Anas
Format: Journal Article
Language:English
Published: United States 19.02.2015
Subjects:
Adolescent
Adult
Aged
Brentuximab Vedotin
Combined Modality Therapy
Female
Hematopoietic Stem Cell Transplantation
Hodgkin Disease - mortality
Hodgkin Disease - therapy
Humans
Immunoconjugates - therapeutic use
Immunotherapy
Male
Middle Aged
Recurrence
Remission Induction
Survival Analysis
Transplantation, Autologous
Treatment Failure
Young Adult
ISSN:1528-0020, 1528-0020
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Summary:We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years. Median overall survival and progression-free survival were estimated at 40.5 months and 9.3 months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58% (95% CI: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control. The trial was registered at www.clinicaltrials.gov as #NCT00848926.
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ISSN:1528-0020
1528-0020
DOI:10.1182/blood-2014-08-595801