Date: 2011-12-11
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 53rd American Society of Hematology (ASH) Annual Meeting
Company: Micromet (USA-Germany)
Product: Blinatumomab (MT103)
Action
mechanism: bispecific antibody. Blinatumomab (MT103) is a next-generation monoclonal antibody designed to direct the body's cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin's lymphomas.
Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the FDA for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
Disease: diffuse large B cell lymphoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This open-label, single-arm phase 1 study was designed to assess the safety and efficacy of blinatumomab in 76 patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) whose disease progressed despite prior treatment. Endpoints included safety, objective response rate, progression-free survival, time to disease progression, and overall survival.
Latest
news: New findings from a phase 1 trial have been presented at the 53rd Annual American Society of Hematology (ASH) Annual Meeting. These data demonstrate Micromet's blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL). Data presented at the meeting focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.
The most common clinical adverse events were grade 1 or 2 and included flu-like symptoms, pyrexia, headache, and fatigue. These were most frequently seen at the onset of treatment. The clinically most relevant adverse events were fully reversible central nervous system (CNS) events. A key objective of this study was to optimize the type and timing of steroid administration to mitigate the risk of developing CNS adverse events. Notably, no discontinuations due to CNS events were observed in the five patients who received an optimized steroid schedule including dexamethasone administration starting 12 hours before the start of blinatumomab infusion.
