Tag: Micromet
Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab
Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. 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. The compound is being developed for the treatment of leukemia and B cell lymhoma.
The data 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 a 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. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.
Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).
Data 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.
Company News: Keeping an Eye on Micromet
The human immune system is one of the body’s most powerful weapons to combat cancer, and therefore a lot of companies are working to activate it against tumors, writes Siegfried Hofmann in Handelsblatt this week. As an example, he features the BiTE antibodies developed by Micromet, Inc. These BiTE antibodies bind to T cells and subsequently to specific tumor antigens on cancer cells. Thereby, the T cells are activated and start destroying the tumor cells. The first drug candidate is in late-stage clinical development to treat Leukemia, Hofmann writes. The article is also being featured in the internet version of Wirtschaftswoche.
Micromet recently started a Phase 2 trial of its lead product blinatumomab (MT103) in relapsed/refractory acute lymphoblastic leukemia (ALL), a very difficult to treat disease. If initial results generated from this trial are compelling, Micromet plans to discuss with the FDA potential avenues to accelerate blinatumomab’s path to market. Blinatumomab is also being tested for the treatment of non-Hodkin’s Lymphoma (NHL). In addition, the company announced it hired Joseph Lobacki as Senior Vice President and Chief Commercial Officer. Previously, Lobacki was Senior Vice President and General Manager, Transplant and Oncology at Genzyme. Christian Itin, CEO of Micromet said “his extensive sales, marketing and medical affairs experience will be critical as we look to prepare the marketplace for blinatumomab’s potential launch.”
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.