Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL
Max S Topp, Nicola Gökbuget, Gerhard Zugmaier, Evelyn Degenhard, Marie-Elisabeth Goebeler, Matthias Klinger, Svenja A Neumann, Heinz A Horst, Thorsten Raff, Andreas Viardot, Matthias Stelljes, Markus Schaich, Rudolf Köhne-Volland, Monika Brüggemann, Oliver G Ottmann, Thomas Burmeister, Patrick A Baeuerle, Dirk Nagorsen, Margit Schmidt, Hermann Einsele, Gert Riethmüller, Michael Kneba, Dieter Hoelzer, Peter Kufer, Ralf C Bargou, Max S Topp, Nicola Gökbuget, Gerhard Zugmaier, Evelyn Degenhard, Marie-Elisabeth Goebeler, Matthias Klinger, Svenja A Neumann, Heinz A Horst, Thorsten Raff, Andreas Viardot, Matthias Stelljes, Markus Schaich, Rudolf Köhne-Volland, Monika Brüggemann, Oliver G Ottmann, Thomas Burmeister, Patrick A Baeuerle, Dirk Nagorsen, Margit Schmidt, Hermann Einsele, Gert Riethmüller, Michael Kneba, Dieter Hoelzer, Peter Kufer, Ralf C Bargou
Abstract
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.
Source: PubMed