On May 15, 2017 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported that it has achieved the recruitment goal with the inclusion of currently 540 patients for the pivotal IMPALA study in metastatic colorectal cancer "mCRC" (Press release, Mologen, MAY 15, 2017, View Source [SID1234519133]). The aim of this study is to show that a switch maintenance therapy with the immunotherapeutic agent lefitolimod can lead to a prolongation of overall survival in patients with mCRC. With the finalization of recruitment, the company reached the next important milestone in the clinical study program of its lead product lefitolimod. Schedule your 30 min Free 1stOncology Demo! Approximately 540 patients from more than 120 centers in eight European countries, including the five most important European pharmaceutical markets, participate in the study. The study will be evaluated once a certain number of deaths (events) have occurred, which is currently estimated to be reached around two years after completion of patient enrollment. MOLOGEN is continuously and closely monitoring the events and the corresponding timeline for the results.
"We are pleased that the enrollment for IMPALA has been completed and that treatment with lefitolimod is so far well tolerated", said Dr. Matthias Baumann, Chief Medical Officer of MOLOGEN AG. "This is an important milestone for us as the pivotal IMPALA study is by far the largest study for us to date. We look forward to the study results in this high medical need indication, which will be available, once sufficient survival data have been collected. This is currently expected in 2019, which of course depends on the actual overall survival rates.
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Colorectal cancer
Colorectal cancer is one of the most common cancers worldwide with 1,361,000 cases in 2012. In the same year it accounted for approximately 694,000 deaths worldwide. In the US 134,000 cases have occurred in 2012, and 55,000 people have died from this disease.
About IMPALA
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is a pivotal, randomized, international, multicenter, open-label phase III trial. The study aims to prove that a switch maintenance therapy with an active immunotherapy with lefitolimod 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, safety and tolerability, as well as Quality of Life (QoL).
The study is conducted in collaboration with three renowned national study groups: 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 internationally recognized medical experts including Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital, London, UK, as coordinating investigator