Company News: MediGene Publishes First, Preliminary Results from a Phase II Clinical Trial of EndoTAG-1 for the Treatment of Triple Receptor-negative Breast Cancer
– Study Meets Primary Endpoint –
MediGene today announced first preliminary results from its Phase II clinical trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer. The trial in 140 patients was conducted to show efficacy of EndoTAG(TM)-1 against this extremely difficult to treat cancer type, and to further investigate the safety of the drug candidate. The primary endpoint was a progression-free survival rate at 16 weeks of at least 30% of EndoTAG(TM)-1 monotherapy treated patients, and at least 30% of EndoTAG(TM)-1 plus paclitaxel combination treated patients respectively.
Trial results: The group of patients treated with EndoTAG(TM)-1 and paclitaxel combination therapy showed a progression-free survival rate after 16 weeks of treatment of 59.1% (95% confidence interval: 43.2% – 73.7%). The progression-free survival rate of the group with EndoTAG(TM)-1 monotherapy was 34.2% (18,6 % – 51,4 %). In the group that received paclitaxel monotherapy, the progression-free survival rate was 48%. (27,8 % – 68,7%).
Further data, including secondary endpoints, are currently being evaluated and will be published within the next few weeks. Upon conclusion of this analysis, an overall trial evaluation will therefore be possible. The data published today are based on a centralized image evaluation of the trial results regarding progression-free survival. For more information, please see the full press release.