Mologen AG has started to submit clinical trial applications for MGN1703 in metastatic colorectal cancer to the competent authorities in Europe. The applications will also be submitted to the responsible ethics committees. The pivotal phase III clinical trial IMPALA is designed as an open-label, two-arms, randomized, controlled and multicenter study.

The aim of the study is to evaluate the efficacy of the first-line maintenance treatment with MGN1703 in patients with metastatic colorectal cancer. The primary endpoint of the study is to determine patient overall survival. It is planned to include patients from more than 100 sites in eight European countries, including the five major European pharma markets.

In addition, three renowned national cancer associations will participate in the IMPALA trial and contribute their specific expertise: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Espaniol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) in France. MOLOGEN expects to start first patient enrollment in the second half of 2014, directly after receipt of the necessary approvals. The IMPALA trial is based on the data from the phase II study IMPACT presented at ESMO World Congress on Gastrointestinal Cancer in July 2013.

The study was chosen by ESMO to be among the most important contributions of the conference. The final analysis provided proof-of-concept evidence for MGN1703 in terms of efficacy and safety. The pivotal phase III international trial is to confirm these results in a larger number of patients.

IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. The trial will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL).

The design of the phase III study IMPALA will be presented at the ESMO 16th World Congress in Gastrointestinal (GI) Cancer 2014 in Barcelona, Spain, from 25-28 June 2014.