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

Authors: Younes, A.; Gopal, A. K.; Smith, S. E.; Ansell, S. M.; Rosenblatt, J. D.; Savage, K. J.; Ramchandren, R.; Bartlett, N. L.; Cheson, B. D.; de Vos, S.; Forero-Torres, A; Moskowitz, C. H.; Connors, J. M.; Engert, A.; Larsen, E. K.; Kennedy, D. A.; Sievers, E. L.; Chen, R
Article Title: Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma
Abstract: PURPOSE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Journal Title: Journal of Clinical Oncology
Volume: 30
Issue: 18
ISSN: 0732-183X
Publisher: Unknown  
Journal Place: United States
Date Published: 2012
Start Page: 2183
End Page: 2189
Language: eng
Notes: LR: 20140418; GR: K12 CA001727/CA/NCI NIH HHS/United States; GR: P30 CA016672/CA/NCI NIH HHS/United States; JID: 8309333; 0 (Antineoplastic Agents); 0 (Immunoconjugates); 0 (cAC10-vcMMAE); CIN: Clin Adv Hematol Oncol. 2012 Jul;10(7):468-71. PMID: 22895289; CIN: J Clin Oncol. 2012 Jun 20;30(18):2171-2. PMID: 22547611; OID: NLM: PMC3646316; 2012/03/26 [aheadofprint]; 2012/05/21 [aheadofprint]; 2012/05/29 [aheadofprint]; ppublish