IMPULSE study (indication small-cell lung cancer)

The trial titled “Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy” (IMPULSE study) has overall survival as the primary endpoint and compares lefitolimod (MGN1703) versus best standard of care. The study includes 102 patients who are suffering from extensive disease small cell lung cancer (SCLC) and whose tumors have responded after four cycles of standard first line therapy with chemotherapeutics. Patients in the lefitolimod arm receive treatment with MGN1703 until renewed progression of the cancer disease. The enrollment of patients for the study which started in 2014 was successfully concluded in October 2015. Key results have been announced in April 2017. IMPULSE shows positive results regarding overall survival (OS) in two subgroups of patients in comparison to the control group (standard therapy). The results of this SCLC study provide significant guidance for defining patient populations that, even beyond this study, are most likely to benefit from the immune surveillance reactivator lefitolimod, even though in this highly challenging indication the primary endpoint OS was not met in the overall study population. A more extensive evaluation of the IMPULSE data is currently ongoing. 

Small cell lung cancer (SCLC)
Lung cancer is one of the most common cancer diseases. The two main types are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). SCLC is a fast-growing type of lung cancer that usually spreads more quickly than NSCLC.

In the US the estimated number of new lung cancer cases per year is around 230,000 (228,000) and in Europe more than 400,000 (410,000). The estimated number of deaths per year is [ca. 160,000] 159,000 in the US and [more than 350,000] 353,000 in Europe. The proportion of small cell lung cancer is approximately 15-20% of all lung cancer cases.

When first diagnosed, approx. 60-80% of the SCLC-patients have already distant metastases or extensive local involvement. This advanced stage is called “extensive disease”. The prognosis for extensive disease SCLC is still very poor: median overall survival is less than 12 months and only few patients survive for more than two years. Thus, there is a high unmet medical need for new treatment options.