title: Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma.
abstract: 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.
authors.affiliation: University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Gopal
authors.affiliation: City of Hope National Medical Center, Duarte, CA;
authors.forename: Robert
authors.initials: R
authors.lastname: Chen
authors.affiliation: 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: 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 Center for Lymphoid Cancer, Vancouver, BC, Canada;
authors.forename: Kerry J
authors.initials: KJ
authors.lastname: Savage
authors.affiliation: British Columbia Cancer Agency Center for Lymphoid Cancer, Vancouver, BC, Canada;
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Connors
authors.affiliation: 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: Takeda Pharmaceuticals International Company, Cambridge, MA; and.
authors.forename: Xuedong
authors.initials: X
authors.lastname: Chi
authors.affiliation: Seattle Genetics, Inc., Bothell, WA;
authors.forename: Eric L
authors.initials: EL
authors.lastname: Sievers
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000079963:Brentuximab Vedotin; D003131:Combined Modality Therapy; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000401:mortality / Q000628:therapy*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D016019:Survival Analysis; D014182:Transplantation, Autologous; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D018796:Immunoconjugates; D000079963:Brentuximab Vedotin