title: Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. ayounes@mdanderson.org
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Gopal
authors.forename: Scott E
authors.initials: SE
authors.lastname: Smith
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Ansell
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Rosenblatt
authors.forename: Kerry J
authors.initials: KJ
authors.lastname: Savage
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Ramchandren
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
authors.forename: Sven
authors.initials: S
authors.lastname: de Vos
authors.forename: Andres
authors.initials: A
authors.lastname: Forero-Torres
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Connors
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.forename: Emily K
authors.initials: EK
authors.lastname: Larsen
authors.forename: Dana A
authors.initials: DA
authors.lastname: Kennedy
authors.forename: Eric L
authors.initials: EL
authors.lastname: Sievers
authors.forename: Robert
authors.initials: R
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000079963:Brentuximab Vedotin; D018572:Disease-Free Survival; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D018796:Immunoconjugates; D000079963:Brentuximab Vedotin