This is the first ovarian cancer study to use a combination of investigational medicines that can be taken orally.
Antoine Yver, Head of Oncology in AstraZeneca's Global Medicines Development unit said: “The NCI data is extremely compelling, showing that the combination of olaparib and cediranib nearly doubled the progression-free survival benefit compared to olaparib alone. This could offer real benefits to patients who currently have very limited treatment options. At AstraZeneca we are committed to the rapid development of our pipeline for ovarian cancer and we believe that collaboration is an important component of this. We fully support the NCI in their plans to conduct two late stage studies to further investigate the combination. We also look forward to exploring the Phase II data in more detail to inform our future development plans for olaparib and cediranib.”
Ovarian cancer is a serious, life-threatening disease and is the seventh most commonly diagnosed cancer in women worldwide1. Historically, initial and late-stage treatment options for women diagnosed with ovarian cancer have been limited and patients remain heavily reliant on chemotherapy. Although recent advances are providing new hope of improved outcomes, there remains significant unmet medical need in this disease.
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 monotherapy2 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.
1 WHO Globocan 2012 Cancer Factsheet, http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed 22 May 2014.
2 Ledermann JA, et al. Olaparib maintenance therapy in patients with platinum sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. The Lancet Oncology, early online publication 30 May 2014. doi:10.1016/S1470-2045(14)70228-1.
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