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MOLOGEN AG presented further analysis on overall survival from IMPACT study at AACR Conference 2014

DGAP-News: MOLOGEN AG / Key word(s): Study results
MOLOGEN AG presented further analysis on overall survival from IMPACT
study at AACR Conference 2014

04.12.2014 / 14:50

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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