Date: 2013-05-16
Type of information:
phase: 2
Announcement: publication of results for the upcoming ASCO meeting
The abstract of the IIT (#114428) was chosen for inclusion online in the ASCO 2013 Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.
Company: Medigene (Germany)
Product: EndoTAG®-1
Action
mechanism: EndoTAG®-1 is a novel composition of paclitaxel combined with neutral and positive lipids. It attacks activated endothelial cells that are needed for the formation of new tumor blood vessels. The drug candidate selectively attaches itself to newly developed, negatively charged tumor blood vessels, thus attacking only the blood supply of the tumor and not the blood supply of healthy tissue. EndoTAG®-1 is expected to prevent the formation of new vessels and suppress further tumor growth.
Disease: hormone-receptor-positive, HER2-negative breast cancer
Therapeutic area: Cancer - Oncology
Country: Belgium
Trial
details: The trial is entitled "An open-label phase II trial evaluating the efficacy and safety of neoadjuvant EndoTAG®-1 in combination with paclitaxel in patients with HER2-negative high-risk breast cancer. MediGene will provide EndoTAG®-1 for the study. During the investigator initiated trial (IIT), 20 patients diagnosed with HER2-negative breast cancer will be treated with EndoTAG®-1 (22 mg/m2) in combination with paclitaxel (70 mg/m2) once-weekly over a period of twelve weeks as neoadjuvant therapy prior to surgery.
The primary endpoint of the IIT study was the percent reduction in magnetic resonance imaging (MRI) estimated tumour volume at the end of EndoTAG®-1 plus paclitaxel administration as compared to baseline. Safety, pathological complete response (pCR), defined as no residual invasive tumour in breast and axillary nodes at surgery, and correlation between percentage reduction in MRI estimated tumour volume and pCR were also evaluated.
The trial was conducted by Prof. Dr. Ahmad Awada, Head of the Medical Oncology Clinic at the Institut Jules Bordet in Brussels, Belgium, and principal investigator in the previously conducted EndoTAG®-1 phase II trial in locally relapsed and/or metastatic advanced Triple Negative Breast Cancer (TNBC).
Latest
news: * On November 8, 2011, MediGene has announced that Prof. Dr. Ahmad Awada, principal investigator in the EndoTAG®-1 phase II trial in TNBC, will conduct an investigator initiated trial (IIT) of EndoTAG®-1 in hormone-receptor-positive, HER2-negative breast cancer, which is an additional potential indication for the drug. Treatment of the patients with EndoTAG®-1 is expected to be completed in the second half of 2012. Following EndoTAG®-1 therapy, the patients will be treated with standard chemotherapy and, subsequently, surgery. Endpoints of the trial include reduction in linear tumour size as measured by MRI as well as pathological complete response (pCR) at the time of surgery. The trial results are expected in 2013. * On May 16, 2013, Medigene has announced the publication of final results from the phase II investigator initiated trial (IIT) of neoadjuvant EndoTAG®-1 in HER2-negative high risk breast cancer. The primary endpoint of this efficacy study was met, and the EndoTAG®-1 and paclitaxel combination showed promising preliminary activity as preoperative treatment, especially in patients with triple-negative breast cancer (TNBC). Fifteen patients diagnosed with non-metastatic HER2-negative breast cancer (ECOG status 0/1) were treated with EndoTAG®-1 (22 mg/m2) in combination with paclitaxel (70 mg/m2) once-weekly over a period of twelve weeks as neoadjuvant therapy. Following EndoTAG®-1 therapy, the patients received standard chemotherapy FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks and, subsequently, surgery. Eleven out of 15 patients showed a reduction in tumour volume of 80% or greater at the end of EndoTAG®-1 plus Paclitaxel treatment. The median percent reduction in MRI estimated tumour volume was 90% (95% Confidence Interval: 69-99%), (p<0.001, sign test) for the 14 patients that underwent surgery; 99% (CI: 87-100%) for patients with pCR and 84% (CI:50-95%) for patients with no pCR. Best results were observed in the TNBC patients (6 out of 15 patients) all of whom showed a reduction of tumour volume by 87 - 100%. Treatment in this group resulted in a pathological complete response (pCR) in five out of the six patients. During the treatment, grade 3 hypersensitivity reactions to EndoTAG®-1 were observed in 4 patients, two patients had a grade 3 increase in transaminases and 1 patient grade 4 neutropenia.* On April 11, 2013, Medigene has announced that the results from the Phase 2 investigator initiated trial (IIT) of EndoTAG®-1 in HER2-negative breast cancer will be published for the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO). The abstract (#114428), entitled "Feasibility study of cationic liposome-encapsulated paclitaxel in combination with paclitaxel followed by FEC as induction therapy in HER2-negative breast cancer" was chosen for inclusion online in the ASCO 2013 Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, and will be released at www.asco.org on May 15, 2013. The aim of the exploratory open-label Phase 2 IIT was to evaluate the efficacy and safety of neoadjuvant EndoTAG®-1 in combination with paclitaxel in patients with HER2-negative breast cancer.
