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      72% complete response in Ph II leukemia study of Amgen's blinatumomab
      Article | 21 May 2012

      USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, has announced updated results from a Phase II study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study.

      Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE) antibodies, designed to harness the body's cell-destroying T cells to kill cancer cells. It is the lead compound of Micromet (Nasdaq: MITI), which entered a collaboration with Amgen last year worth a potential $990 million to Micromet for BiTE antibodies against three undisclosed solid tumor targets (The Pharma Letter July 12, 2011). However, Amgen decided to acquire Micromet, a $1.16 billion transaction (TPL January 27) which completed in March.

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      Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL. Full results of the study will be presented during an oral abstract session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 4.

      Study results

      In this Phase II single-arm dose-ranging trial, 26 of the 36 patients treated with blinatumomab across all of the tested doses and schedules achieved a CR or complete response with partial hematologic recovery (CRh). All but two patients achieved a molecular response, meaning there was no evidence of leukemic cells by polymerase chain reaction.

      For patients who received the selected dose and schedule, the most common adverse events were grade one or two and included pyrexia (70%), headache (39%), tremor (30%) and fatigue (30%). These were most frequently seen at the onset of treatment in cycle one. Reversible central nervous system events led to treatment interruptions in six patients with two permanently discontinuing therapy. Cytokine release syndrome led to treatment interruption in two patients. One patient had a fatal event of fungal infection that the investigator considered related to treatment.

      At the time of the analysis, median survival was 9.0 (8.2, 15.8) months with a median follow-
      up period of 10.7 months. In the group of patients who received the selected dose, median survival was 8.5 months. The median duration of response in the 26 patients who responded to treatment was 8.9 months.

      "For these patients with limited treatment options, the remission rate observed in the trial is a vast improvement over the current standard of care," said Max Topp, a professor at the Department of Internal Medicine II, University of Wuerzburg and chairman of the study. "These results also represent significant progress in our research of immunotherapies; a new approach to fighting cancer that we believe could make a real difference for patients," Prof Topp added.


      /C O R R E C T I O N -- Amgen/
      In the news release, Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, issued 16-May-2012 by Amgen over PR Newswire, we are advised by the company that the third paragraph now includes additional safety information. The complete, corrected release follows:

      Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate Of Complete Response In Adult Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia. Greater than 70 Percent of Patients in the Study Achieved Complete Response. Median Survival 9.0 Months, with a Median Follow-up of 10.7 Months.

    • Appears EU approval 2012/2013
      Appears FDA/US approval 2013
      Or so I opine...

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