Micromet has announced that the German Multicenter ALL Study Group (GMALL) presented phase-II clinical data of the BiTE antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany. It showed a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD).
The patients included in this phase II clinical trial were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow.
The primary endpoint is MRD response within four cycles of treatment. MRD response is defined as the elimination of ALL cancer cells in patients with MRD below the limit of detection.
The achievement of the primary endpoint requires that at least 22% of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study.
Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positive patients after failure of treatment with bcr-abl inhibitors, and patients with t(4;11) translocations.