MOLOGEN AG
MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014
MOLOGEN AG / Key word(s): Study results MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014 – Promising overall survival data from subgroup analysis from IMPACT study – Design of pivotal study IMPALA supported by these findings Berlin, December 4, 2014 – MOLOGEN, a biotechnology company, presented promising data on overall survival of patient subgroups from the IMPACT study with MGN1703. The findings are based on the analysis performed in 2013 and were shown for the first time at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy 2014 in Orlando, Florida. The design of the pivotal study IMPALA reflects these results. IMPALA is currently recruiting patients. The presented data showed that overall survival may improve in subgroups of patients when treated with MGN1703. Notably, the patient subgroup with a response to prior induction chemotherapy and who received MGN1703 maintenance therapy showed promising overall survival benefit compared to placebo patients (median overall survival: 24.5 vs. 15.1 months). This suggests that responders to induction therapy may benefit the most from a switch maintenance treatment with MGN1703. This is reflected in the IMPALA trial where ‘response to induction therapy’ is one of the main inclusion criteria. The analyses on overall survival were performed on the same subgroups of patients of the IMPACT trial, which already reported improved results in terms of progression-free survival. The cut-off date for these evaluations was March 2013. Several long-surviving patients are delaying the final evaluation of overall survival. Therefore, the reported overall survival data is still preliminary. IMPACT was a randomized placebo-controlled phase II trial with the cancer immune therapy MGN1703 in metastatic colorectal cancer which evaluated MGN1703 as maintenance therapy after standard first-line induction therapy. The findings on patient subgroups have been implemented in the pivotal IMPALA trial as inclusion criteria and stratification factors, respectively. “The presented overall survival data are promising and the findings from these subgroup analyses support the IMPALA study design and endpoints. The predictive factors are being used in the IMPALA trial to include patients who are more likely to benefit from the treatment of MGN1703,” said Prof. Dr. Werner Scheithauer, Clinical Division of Oncology, Department of Medicine I, University Hospital in Vienna, Austria. Prof. Dr. Scheithauer is one of the coordinating investigators of the IMPACT trial and also a member of the steering committee of the pivotal IMPALA study. About IMPACT Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months. The patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was observed. The primary endpoint of the study was to determine progression-free survival of the patients. Secondary study endpoints included overall survival, progression-free survival from start of induction therapy, response rates and safety, as well as collection of immunological and pharmacodynamic data. About IMPALA Leading medical associations will collaborate: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. The steering committee consists of international medical experts; among others the coordinating study investigators Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, Director of the Clinic for Medical Oncology, Klinik für Tumorbiologie (Tumor Biology Center), Freiburg, Germany. For more information on the trials IMPACT and IMPALA please visit www.clinicaltrials.gov. About MGN1703 MOLOGEN AG The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and lung cancer (randomized controlled trial). A second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully. With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies. MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange. Memberships in associations: MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. Contact Note about risk for future predictions
04.12.2014 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
Language: | English | |
Company: | MOLOGEN AG | |
Fabeckstraße 30 | ||
14195 Berlin | ||
Germany | ||
Phone: | 030 / 841788-0 | |
Fax: | 030 / 841788-50 | |
E-mail: | presse@mologen.com | |
Internet: | www.mologen.com | |
ISIN: | DE0006637200 | |
WKN: | 663720 | |
Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart | |
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