Mologen reports final Phase II data for lefitolimod in extensive-stage SCLC

Mologen AG (Xetra:MGN) reported final data from the Phase II IMPULSE trial in 103 patients with extensive-stage small cell lung cancer (SCLC) showing that lefitolimod (MGN1703) had “no relevant effect” on the primary endpoint of overall survival (OS) in the overall population. The open-label, international trial enrolled patients whose tumors responded to standard first-line chemotherapy to receive maintenance treatment with twice-weekly subcutaneous 60 mg lefitolimod or standard of care (SOC).

In two predefined subgroups, Mologen said lefitolimod showed an OS benefit compared with SOC in patients with a low number of activated B cells (HR=0.53, 95% CI: 0.26, 1.08) and in patients with reported chronic obstructive pulmonary disease (COPD) (HR=0.48, 95% CI: 0.2, 1.17). The company is in discussions with clinical and scientific experts regarding potential next steps for lefitolimod in the indication...