EndoTAG-1: Additional Phase II data
Additional data from an open-label, active-controlled, international Phase II trial in 133 evaluable TNBC patients showed that once-weekly 22 mg/m 2 EndoTAG-1 plus 70 mg/m 2 paclitaxel led to a median OS of 13 months vs. 11.9 months for twice-weekly 44 mg/m 2 EndoTAG-1 monotherapy and 10.1 months for once-weekly 90 mg/m 2 paclitaxel monotherapy. In the per protocol (PP) population (n=124), median OS was 15.1 months for the EndoTAG-1 combination arm vs. 12.5 and 8.9 months for the EndoTAG-1 and paclitaxel monotherapy arms, respectively. In a subgroup of 119 patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and who received first-line treatment after tumor relapse, median OS was 17.8, 11.7 and 10.1 months for the EndoTAG-1 combination, EndoTAG-1 monotherapy and paclitaxel monotherapy arms, respectively. MediGene said the trial was not powered for intergroup comparisons. Data were presented at the San Antonio Breast Cancer Symposium. MediGene could not be reached for comment. ...