title: Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma.
abstract: Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.
authors.affiliation: City of Hope National Medical Center, Duarte, CA;
authors.forename: Robert
authors.initials: R
authors.lastname: Chen
authors.affiliation: Division of Medical Oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Gopal
authors.affiliation: Division of Hematology and Medical Oncology, Department of Medicine, Loyola University Medical Center, Maywood, IL;
authors.forename: Scott E
authors.initials: SE
authors.lastname: Smith
authors.affiliation: Mayo Clinic, Rochester, MN;
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Ansell
authors.affiliation: Division of Hematology and Oncology, Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL;
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Rosenblatt
authors.affiliation: British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada;
authors.forename: Kerry J
authors.initials: KJ
authors.lastname: Savage
authors.affiliation: British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada;
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Connors
authors.affiliation: German Hodgkin Study Group, Department of Internal Medicine I, University Hospital of Cologne, Cologne, Germany;
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.affiliation: Seattle Genetics, Inc., Bothell, WA;
authors.forename: Emily K
authors.initials: EK
authors.lastname: Larsen
authors.affiliation: Millenium Pharmaceuticals, Inc., Cambridge, MA; and.
authors.forename: Dirk
authors.initials: D
authors.lastname: Huebner
authors.affiliation: Seattle Genetics, Inc., Bothell, WA;
authors.forename: Abraham
authors.initials: A
authors.lastname: Fong
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
mesh_terms: D000328:Adult; D000079963:Brentuximab Vedotin; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D012074:Remission Induction; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D018796:Immunoconjugates; D000079963:Brentuximab Vedotin