title: Experience of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large-cell lymphoma in the Named Patient Program: Review of the literature.
abstract: Brentuximab vedotin was made available via a Named Patient Program (NPP) to non-US/Canadian patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL) until approval in their respective countries. We re-evaluated the efficacy and safety NPP data in a pooled analysis. Through a systematic literature review, 21 NPP publications were identified describing 14 cohorts (N=245). Among patients with a specified diagnosis, 207 had HL, 28 had ALCL, and one had CD30+ T-cell lymphoma (not specified). In cohorts reporting response, overall response and complete remission rates were 67% and 26%, respectively, in R/R HL, and 75% and 74%, respectively, in R/R ALCL. Incidences of grade 3/4 neurologic and hematologic toxicities were 6% and 12%, respectively; 5% of patients discontinued because of toxicity. In real-world practice, response rates and tolerability to brentuximab vedotin are similar to those reported in the two pivotal phase 2 trials in these settings.
authors.affiliation: Institute of Haematology and Medical Oncology, 'L. & A. Seràgnoli', University of Bologna, Bologna, Italy. Electronic address: pierluigi.zinzani@unibo.it.
authors.forename: P L
authors.initials: PL
authors.lastname: Zinzani
authors.affiliation: University Hospital of Cologne, Cologne, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Sasse
authors.affiliation: The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: J
authors.initials: J
authors.lastname: Radford
authors.affiliation: Millennium Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
authors.forename: O
authors.initials: O
authors.lastname: Shonukan
authors.affiliation: Global Outcomes and Epidemiology Research (GOER), Millennium Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
authors.forename: V
authors.initials: V
authors.lastname: Bonthapally
mesh_terms: D000079963:Brentuximab Vedotin; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy*; D012008:Recurrence
chemical_list: D018796:Immunoconjugates; D000079963:Brentuximab Vedotin
keywords: Anaplastic large cell lymphoma; Antibody–drug conjugate; Brentuximab vedotin; CD30; Hodgkin lymphoma; Named Patient Program