Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL

• Published in: Blood Vol. 120; no. 26; pp. 5185 - 5187
• Main Authors: Topp, Max S., Gökbuget, Nicola, Zugmaier, Gerhard, Degenhard, Evelyn, Goebeler, Marie-Elisabeth, Klinger, Matthias, Neumann, Svenja A., Horst, Heinz A., Raff, Thorsten, Viardot, Andreas, Stelljes, Matthias, Schaich, Markus, Köhne-Volland, Rudolf, Brüggemann, Monika, Ottmann, Oliver G., Burmeister, Thomas, Baeuerle, Patrick A., Nagorsen, Dirk, Schmidt, Margit, Einsele, Hermann, Riethmüller, Gert, Kneba, Michael, Hoelzer, Dieter, Kufer, Peter, Bargou, Ralf C.
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 20.12.2012; Americain Society of Hematology
• Subjects: Adult; Antibodies, Bispecific - therapeutic use; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Combined Modality Therapy; Disease-Free Survival; Follow-Up Studies; Hematologic and hematopoietic diseases; Hematopoietic Stem Cell Transplantation; Humans; Kaplan-Meier Estimate; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Medical sciences; Neoplasm, Residual; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma - blood; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma - mortality; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma - pathology; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma - therapy; Recurrence; Survival Analysis; Transplantation, Homologous; Human; Relapse free survival; Hematology; Follow up study; Lymphoproliferative syndrome; Phase II trial; Malignant hemopathy; Long term; Precursor B cell acute lymphoblastic leukemia; Cancer
• DOI: 10.1182/blood-2012-07-441030
• ISSN: 0006-4971

Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell–engaging bispecific Ab construct induced an 80% MRD response rate. In the present study, we show that after a median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable study cohort of 20 patients was 61% (Kaplan-Meier estimate). The hema-tologic relapse-free survival rate of a subgroup of 9 patients who received allogeneic hematopoietic stem cell transplantation after blinatumomab treatment was 65% (Kaplan-Meier estimate). Of the subgroup of 6 Philadelphia chromosome–negative MRD responders with no further therapy after blinatumomab, 4 are in ongoing hematologic and molecular remission. We conclude that blinatumomab can induce long-lasting complete remission in B-lineage ALL patients with persistent or recurrent MRD. The original study and this follow-up study are registered at www.clinicaltrials.gov as NCT00198991 and NCT00198978, respectively.