Tag: BiTE (R)

Company News: Micromet Initiates Global Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Additional information regarding this Phase 2 study is available at the U.S. government’s clinical trials database at http://www.clinicaltrials.gov.

Blinatumomab Clinical Experience in Adult R/R ALL

Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh* following treatment with blinatumomab1. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.

Company News: Study Demonstrates Micromet’s Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leukemia

75% of patients achieved a complete remission, with no evidence of remaining leukemic cells in blood or bone marrow
– Data add to a growing body of clinical evidence demonstrating blinatumomab’s potential to be used across the course of the disease

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet’s blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy. 1 Blinatumomab is the most advanced of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab.  All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival.  Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission.  In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy.  With current approaches, complete remission rates range from 17-45%. 2-6 Standard chemotherapy is associated with a mortality rate of up to 23%. 7 The average five-year survival rate for adult ALL patients after first relapse is 7%. 5

 

Click here to read the abstract

 

References:

  1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
  2. Kantarjian H, et al. Cancer. 2010;116:5568–5574.
  3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
  4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
  5. Fielding  A, et al. Blood. 2007;109(3):944-950.
  6. O’Brien S, et al. Cancer. 2008;113:3186–3191.
  7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.