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(April 24, 2017)
DGAP-News: MOLOGEN AG / Key word(s): Study results
Press Release N 9 / 2017 on 24 April 2017
MOLOGEN AG: Positive subgroup results of the exploratory phase II IMPULSE study of lefitolimod in extensive-disease small-cell lung cancer (SCLC)
- Clinically relevant subgroups benefit from the treatment with lefitolimod in this study
- Results are indicative for the further development of lefitolimod in SCLC
Berlin, 24 April 2017 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced the key results of the exploratory phase II IMPULSE study. The randomized study evaluated the efficacy and safety of lefitolimod in patients with extensive-disease small-cell lung cancer (SCLC). IMPULSE shows positive results regarding overall survival (OS) in two subgroups of patients in comparison to the control group (standard therapy). Additional, potentially promising subgroups will be identified. 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.
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.
Small-cell lung cancer (SCLC)
The two main types are non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). SCLC is a fast-growing type of lung cancer that usually spreads more quickly than NSCLC and represents approximately 15-20% of all lung cancer cases.
When first diagnosed, approx. 60-80% of SCLC-patients already have distant metastases or extensive local spreading of the disease called "extensive-disease" SCLC. The prognosis for extensive-disease SCLC is still very poor: median overall survival (OS) is less than 12 months and only few patients survive more than two years. Thus, there is a high unmet medical need for new treatment options.
For more information on the clinical development program including IMPULSE, IMPALA, the combination study, and TEACH please visit www.clinicaltrials.gov.
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