DGAP-News

MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer (SCLC) - Seite 2

The IMPULSE study shows positive results in two pre-defined and clinically relevant subgroups of patients. Notably, a strong overall survival (OS) benefit was shown in comparison to the control arm (local standard of care) in patients with a low count of activated B cells (hazard ratio 0.59, 95% confidence interval 0.29-1.21), an important immune parameter. Moreover, a benefit was seen in patients with reported Chronic Obstructive Pulmonary Disease (COPD), a frequent underlying disease (hazard ratio 0.54, 95% confidence interval 0.21-1.38).

The safety profile of lefitolimod is favorable. The most common adverse events in the IMPULSE population were cough, asthenia, headache, nausea, and back pain. Adverse events may also be due to underlying diseases and/or adjunctive therapy.

"We have seen promising efficacy signals in subgroups of patients in this very difficult-to-treat- indication. We are committed to further analyze the data and to continue the development of lefitolimod in small-cell lung cancer, where there are no better current treatment options than chemotherapy. Therefore, an important medical need exists for new and/or complementary combination treatment alternatives. Moreover, it would also be helpful to evaluate lefitolimod in patients with SCLC in combination with other immuno-oncological drugs," said Dr Ronald Carter, Acting CMO of MOLOGEN AG.

The present findings from IMPULSE provide additional key insights into the role of TLR9 agonists in the treatment of cancer, and confirm there is significant opportunity to improve outcomes for patients in this therapeutic area.

A more extensive evaluation of the IMPULSE data is currently ongoing. The full IMPULSE study results will be presented at international scientific conferences.

MOLOGEN's ongoing development programs, especially the pivotal IMPALA study, are running independently from these study results, given these are different indications.

Three more clinical studies with lefitolimod

Further to the IMPULSE study, lefitolimod is currently being evaluated in the pivotal phase III IMPALA study for first-line maintenance treatment of metastatic colorectal cancer (mCRC); recruitment for this trial is expected to be finalized soon. Furthermore, a phase I study of lefitolimod in combination with the commercially available checkpoint inhibitor Yervoy^(R) (ipilimumab) in other solid tumors is being conducted in collaboration with MD Anderson Cancer Center, Texas. In addition, lefitolimod is also being investigated in a phase I study in HIV-infected patients (TEACH). Top-line results are expected in summer 2017.