EndoTAG-1: Final Phase II data

Final data from an investigator-initiated Phase II trial in 15 patients with non-metastatic HER2-negative breast cancer showed that once-weekly 22 mg/m 2 EndoTAG-1 plus 70 mg/m 2 paclitaxel as neoadjuvant therapy led to a reduction in MRI-estimated tumor volume from baseline to week 12, the primary endpoint, of >=80% in 11 patients. The median percent reduction in MRI-estimated tumor volume was 90% for the 14 patients that underwent surgery, 99% for patients who achieved a pathological complete response and 84% for patients who did not achieve a pathological complete response. In the 6 patients with triple-negative breast cancer (TNBC), reductions in MRI-estimated tumor volume ranged from 87-100% and 5 of 6 patients achieved a pathological complete response. Grade 3 hypersensitivity reactions were observed in 4 patients, 2 patients had a grade 3 increase in transaminases and 1 patient had grade 4 neutropenia. After EndoTAG-1 treatment, patients received standard chemotherapy (flouroruracil, epirubicin and cyclophosphamide) every 3 weeks until surgery. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...