MediGene reports additional phase II results of EndoTAG-1 for the treatment of triple receptor-negative breast cancer

Clinical trial objective achieved - data confirm positive efficacy trend of EndoTAG-1 combination therapy

25-Jun-2010 - Germany

MediGene AG announces additional phase II clinical trial results of the drug candidate EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer. The extensive data analysis of the three-arm trial conducted in 140 patients confirms a positive efficacy trend of EndoTAGTM-1 in combination with paclitaxel for the treatment of this difficult to treat type of cancer. The objective of the trial was achieved, and the initial conclusion of the preliminary data published on May 6, 2010 was verified.

The primary endpoint was achieved with EndoTAGTM-1 combination therapy. In addition, the analysis of the secondary endpoints (median progression-free survival, non-progression rate, safety, and tolerability) shows further positive results for EndoTAGTM-1 combination therapy.

The trial recruited 140 patients diagnosed with triple receptor-negative breast cancer. These patients were randomized into three treatment groups, receiving either EndoTAGTM-1 in combination with the cytotoxic drug, paclitaxel (55 patients), or EndoTAGTM-1 monotherapy (57 patients). The third group (28 patients) was treated with paclitaxel alone. The patients treated with combination therapy received 22 mg/m2 EndoTAGTM-1 plus 70 mg/m2 paclitaxel once per week. EndoTAGTM-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers across several European countries and India. According to the trial protocol, the trial results are based on centralized data analysis. The patient numbers whose data were eligible for the central analysis are shown in the following results.

The trial objective of evaluating efficacy of EndoTAGTM-1 was achieved by the combination therapy with Paclitaxel. The primary endpoint was a progression-free survival rate of the patients treated with either EndoTAGTM-1 monotherapy or EndoTAGTM-1 plus paclitaxel combination of at least 30% after 16 weeks of treatment. At the same time, the 95% confidence interval, which provides information about the potential error rate, also had to be above 30%. The group of patients treated with EndoTAGTM-1 and paclitaxel combination therapy showed a progression-free survival rate of 59% (26 of 44 patients). The group treated with EndoTAGTM-1 monotherapy achieved a rate of 34% (13/38). For the group treated with paclitaxel monotherapy, this rate was 48% (12/25). Regarding the set confidence interval, the primary trial endpoint was met by the EndoTAGTM-1 combination therapy arm only.

Median progression-free survival time during the trial was 4.2 months in the EndoTAGTM-1 combination therapy arm (52 patients), 3.4 months in the EndoTAGTM-1 monotherapy arm (48), and 3.7 months in the paclitaxel monotherapy arm (25). The rate of patients whose tumors had not progressed further (clinical benefit rate) in treatment week 16 was 59% in the EndoTAGTM-1 combination therapy arm (26/44 patients), 34% in the EndoTAGTM-1 monotherapy arm (13/38), and 50% in the paclitaxel monotherapy arm (12/24). In 76% of the patients in the EndoTAGTM-1 combination therapy arm (38/50), the tumor was either stable or regressive at a certain point in time during the treatment period (best overall response). The corresponding rate was 58% for the EndoTAGTM-1 monotherapy arm (26/45), and 58% for the paclitaxel monotherapy arm (14/24). Safety and tolerability profile of EndoTAGTM-1 was confirmed during the trial. The combination of EndoTAGTM-1 with paclitaxel did not lead to additional toxicity.

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