Safety and efficacy of blinatumomab: a real world data

Ann Hematol. 2020 Apr;99(4):835-838. doi: 10.1007/s00277-019-03854-0. Epub 2020 Feb 20.

Abstract

Despite improvement in survival of newly diagnosed adult precursor B-acute lymphoblastic leukemia/lymphoma (B-ALL), the results of relapsed/refractory disease are poor. Blinatumomab, a bispecific monoclonal antibody directed against CD19/CD3 show clinical activity against relapsed/refractory B-ALL and in minimal residual disease (MRD)-positive patients.We report our "real-world" experience with blinatumomab in patients with relapsed/refractory B-ALL.Twenty-one patients, at a median age 52 years with median disease duration of 10 months, were included. Indications for treatment were hematological relapse (n = 17), MRD positivity (n = 2), inability to continue intensive chemotherapy (n = 1), and bridging to a second alloSCT (n = 1). Blinatumomab was given as first salvage in 11 patients and after at least one prior salvage treatment in eight.Complete response (CR) was newly achieved in 47% and was maintained in 75% of patients with baseline CR. At a median follow-up of 12.4 months, 13 patients were alive, and 11 in CR. Median leukemia-free survival was 8.7 months, and median overall survival was 15.2 months. Median leukemia-free survival and overall survival were not reached in patients proceeding to alloSCT compared to 5.1 and 15.2 months, respectively, for patients who did not receive stem cell transplantation.Treatment was well tolerated with neurological events reported in two patients (10%) and GI events in three patients (14%). Cytokine storm was reported in four patients (19%).In conclusion, treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting.

Keywords: Blinatumomab; Minimal residual disease; Precursor B-acute lymphoblastic leukemia/lymphoma; Salvage therapy.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Bispecific / adverse effects
  • Antibodies, Bispecific / therapeutic use*
  • Antibody Specificity
  • Antigens, CD19 / immunology*
  • Antigens, Neoplasm / immunology*
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use*
  • CD3 Complex / immunology*
  • Combined Modality Therapy
  • Cytokines / metabolism
  • Disease-Free Survival
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neoplasm, Residual
  • Nervous System Diseases / chemically induced
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / pathology
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / therapy
  • Recurrence
  • Remission Induction
  • Retrospective Studies
  • Salvage Therapy*
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Bispecific
  • Antigens, CD19
  • Antigens, Neoplasm
  • Antineoplastic Agents, Immunological
  • CD19 molecule, human
  • CD3 Complex
  • Cytokines
  • blinatumomab