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    DGAP-News  539  0 Kommentare MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014 - Seite 2


    who are more likely to benefit from the treatment of MGN1703," said Prof.
    Dr. Werner Scheithauer, Clinical Division of Oncology, Department of
    Medicine I, University Hospital in Vienna, Austria. Prof. Dr. Scheithauer
    is one of the coordinating investigators of the IMPACT trial and also a
    member of the steering committee of the pivotal IMPALA study.

    About IMPACT
    IMPACT (Immunomodulatory MGN1703 in Patients with Advanced Colorectal
    Carcinoma with Disease Control after Initial First-line Therapy) was a
    phase II, randomized, placebo-controlled, double-blind, multicenter
    clinical study aiming to determine the efficacy of MGN1703 as switch
    maintenance therapy following first-line chemotherapy with or without
    bevacizumab in patients with metastatic colorectal cancer.

    Patients included in the IMPACT study had stabilization, or partial or
    complete remission of their disease after receiving first-line therapy for
    4.5 to 6 months. The patients were randomized to receive either MGN1703 or
    placebo twice per week. The treatment was continued until tumor progression
    was observed. The primary endpoint of the study was to determine
    progression-free survival of the patients. Secondary study endpoints
    included overall survival, progression-free survival from start of
    induction therapy, response rates and safety, as well as collection of
    immunological and pharmacodynamic data.

    About IMPALA
    IMPALA is a randomized, international, multicenter, open-label phase III
    trial. The study aims to prove that a switch maintenance therapy with an
    active immunotherapy leads to an increased overall survival of patients who
    have achieved a response during their first line treatment of metastatic
    colorectal cancer. The primary endpoint is overall survival and secondary
    study endpoints include progression-free survival, toxicity and safety, and
    Quality of Life (QoL).

    Approximately 540 patients from more than 100 European centers, including
    the five major pharma markets, will participate in the study. IMPALA
    started to treat the first patients in mid-September.

    Leading medical associations will collaborate: Arbeitsgemeinschaft
    Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de
    Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire
    en Oncologie (GERCOR) in France. The steering committee consists of
    international medical experts; among others the coordinating study
    investigators Prof. David Cunningham, MD, Department of Medicine and
    Director of Clinical Research, Royal Marsden Hospital in London, and Prof.
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    DGAP-News MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014 - Seite 2 DGAP-News: MOLOGEN AG / Key word(s): Study results MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014 04.12.2014 / 14:50 --------------------------------------------------------------------- MOLOGEN …