title: Tumor-specific recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin lymphoma.
abstract: Tumor-specific variable regions of the clonal immunoglobulin (idiotype, Id) expressed by B cell non-Hodgkin lymphoma (NHL) can be targeted by active immunotherapy. We conducted a phase I/II trial to determine the safety and immunogenicity of a patient-specific, recombinant, mammalian cell-derived Id protein conjugated to keyhole limpet hemocyanin (Id-KLH; MyVax personalised immunotherapy) in 22 patients with follicular NHL in first remission after chemotherapy. Subjects received five subcutaneous immunisations with MyVax plus locally administered granulocyte-macrophage colony-stimulating factor (GM-CSF). Among 21 evaluable patients, 62% mounted Id-specific immune responses. Evoked anti-Id antibodies recognised both recombinant Id and native Id, and could specifically stain autologous tumor cells. At median follow-up of more than 6 years, median progression-free survival is 38 months. Immunisation of follicular lymphoma patients with MyVax Id-KLH is safe and patients often mount tumor-specific immune responses. These results form the basis of a pivotal phase 3 trial of MyVax in follicular NHL.
authors.affiliation: Division of Medical Oncology, Stanford University School of Medicine, Stanford, CA, USA. jtimmerman@mednet.ucla.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Timmerman
authors.forename: Julie M
authors.initials: JM
authors.lastname: Vose
authors.forename: Debra K
authors.initials: DK
authors.lastname: Czerwinski
authors.forename: Wen-Kai
authors.initials: WK
authors.lastname: Weng
authors.forename: Diane
authors.initials: D
authors.lastname: Ingolia
authors.forename: Martha
authors.initials: M
authors.lastname: Mayo
authors.forename: Dan W
authors.initials: DW
authors.lastname: Denney
authors.forename: Ronald
authors.initials: R
authors.lastname: Levy
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007114:Immunization; D007130:Immunoglobulin Idiotypes / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D007167:Immunotherapy / Q000009:adverse effects; D008224:Lymphoma, Follicular / Q000276:immunology* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019496:Cancer Vaccines; D007130:Immunoglobulin Idiotypes; D011994:Recombinant Proteins