10 April 2018 - - Berlin, Germany-based biopharmaceutical company Mologen AG's final evaluation of the randomized exploratory phase II IMPULSE study confirmed findings presented in April 2017 and at the ESMO conference in September 2017, the company said.
The study evaluated the efficacy and safety of lefitolimod in patients with extensive-stage small-cell lung cancer (ES-SCLC). Encouraging signals for beneficial effects on overall survival were observed in two predefined patient subgroups, although in the overall study population no relevant effect on OS could be shown.
The final study analysis included 103 patients suffering from ES-SCLC whose tumors have responded to the standard first-line chemotherapy. IMPULSE showed encouraging signals for an OS benefit in two predefined subsets of patients: (1) In patients with a low number of activated B cells, an important immune parameter (hazard ratio 0.53, 95% confidence interval 0.26-1.08). (2) In patients with reported chronic obstructive pulmonary disease, a common underlying disease for lung cancer.
Furthermore, the final analysis confirmed the favorable safety profile and the mode of action of lefitolimod.
Lefitolimod is a TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications.
Mologen AG is a biopharmaceutical company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, Mologen develops immunotherapies for the treatment of infectious diseases.