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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.
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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