Date: 2011-12-12
Type of information: Results
phase: 2
Announcement: results
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: acute lymphoblastic leukemia
Therapeutic area: Cancer Oncology
Country:
Trial
details: This phase 2 dose-ranging study evaluated the efficacy, safety and tolerability of blinatumomab in adult patients with B-precursor ALL who had relapsed following treatment with standard front-line chemotherapy or allogeneic stem cell transplant. Patients received blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients received a continuous intravenous infusion of blinatumomab at an initial dose of 5 or 15 micrograms per meter squared per day, ranging up to 30 micrograms for the remainder of the treatment. The primary endpoint of the study was the rate of CR/CRh*. Secondary endpoints included molecular response rate, duration of response and overall survival. As of October 10, 2011, 25 patients were evaluable for efficacy and safety. Enrollment in this study is now complete with a total of 36 patients treated. The Company plans to report updated results from this study in 2012.
Latest
news: Data presented at the 53rd Annual American Society of Hematology (ASH) Annual Meeting in San Diego, CA, show that Micromet's blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
In this phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab.
Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*. Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.
A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 - 6 months1-5. 12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months.
The most common adverse events were grade 1 or 2 and included flu-like symptoms, pyrexia, headache, and tremor. These were most frequently seen at the onset of treatment in cycle one. The clinically most relevant adverse events were fully reversible central nervous system and cytokine release syndrome events that led to two discontinuations. There were no treatment related deaths.
Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.
