Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma

Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refr...

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Published in:Journal of clinical oncology Vol. 30; no. 18; p. 2183
Main Authors: Younes, Anas, Gopal, Ajay K, Smith, Scott E, Ansell, Stephen M, Rosenblatt, Joseph D, Savage, Kerry J, Ramchandren, Radhakrishnan, Bartlett, Nancy L, Cheson, Bruce D, de Vos, Sven, Forero-Torres, Andres, Moskowitz, Craig H, Connors, Joseph M, Engert, Andreas, Larsen, Emily K, Kennedy, Dana A, Sievers, Eric L, Chen, Robert
Format: Journal Article
Language:English
Published: United States 20.06.2012
Subjects:
Adolescent
Adult
Aged
Antineoplastic Agents - therapeutic use
Disease-Free Survival
Female
Hodgkin Disease - drug therapy
Humans
Immunoconjugates - adverse effects
Immunoconjugates - therapeutic use
Male
Middle Aged
Recurrence
Young Adult
ISSN:1527-7755, 1527-7755
Online Access:Get more information
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Summary:Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility. The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy.
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2011.38.0410