Date: 2014-05-31
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago
Company: AstraZeneca (UK)
Product: combination of olaparib and cediranib
Action mechanism:
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On May 31, 2014, AstraZeneca announced that as part of the 50th Annual Meeting of the American Society for Clinical Oncology (ASCO), Dr Joyce Liu today presented data on a Phase II study conducted by the American National Cancer Institute (NCI), comparing the efficacy and tolerability of olaparib and cediranib in combination to olaparib alone, for the treatment of women with recurrent platinum-sensitive high-grade serous ovarian cancer (abstract LBA5500). This is the first ovarian cancer study to use a combination of investigational medicines that can be taken orally. The NCI is currently planning to conduct two Phase III trials to further investigate the combination of olaparib and cediranib in ovarian cancer. Olaparib and cediranib are being investigated individually in clinical trials for the treatment of patients with this disease. Olaparib has already shown efficacy as a monotherapy and was recently granted Priority Review by the FDA for the treatment of platinum sensitive relapsed ovarian cancer patients who have a BRCA mutation. The EMA accepted a marketing authorisation application for olaparib in September 2013. In the Phase III ICON 6 trial, cediranib demonstrated significant improvements in progression free survival and overall survival in platinum sensitive relapsed ovarian cancer, when given during and after chemotherapy, compared to chemotherapy alone. AstraZeneca has consulted with regulatory agencies in the US and EU to understand how the results of the ICON 6 study conducted by the UK Medical Research Council (MRC) can best support a potential regulatory submission for approval of cediranib in ovarian cancer. As a result of these interactions, AstraZeneca is working with the MRC to conduct relevant analyses of cediranib data with a view to potential regulatory submissions later this year.
