AstraZeneca has enrolled the first patient in the phase III clinical programme for olaparib, an innovative oral poly ADP ribose polymerase (PARP) inhibitor being investigated for the treatment of BRCA mutated ovarian cancer. The phase III SOLO (Study of OLaparib in Ovarian cancer) programme is designed to determine the benefit, by progression free survival, of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting (SOLO 1), and in the relapsed setting (SOLO 2).
The SOLO 1 study is being conducted in collaboration with the Gynecologic Oncology Group and the SOLO 2 study with the European Network of Gynaecological Oncological Trial Groups. Both trials are randomised, double blind, placebo controlled studies that utilise the tablet formulation of olaparib at a dose of 300mg twice daily.
The initiation of these studies is based on the subgroup analysis by BRCA mutation status of the phase II maintenance study in relapsed ovarian cancer, announced at the American Society of Clinical Oncology (ASCO) 2013 Congress, which demonstrated olaparib’s potential as a maintenance treatment for platinum-sensitive relapsed patients with BRCA mutated ovarian cancer.
As a result of the initiation of this programme, the pre-tax impairment charge of $285 million, which was incurred in December 2011 following the decision not to progress olaparib into phase III development, will be reversed in the third quarter of 2013. The reversal of this impairment charge will be excluded from Core earnings per share.
Antoine Yver, vice president and head of Oncology in AstraZeneca’s Global Medicines Development unit said, “This is a significant milestone for olaparib, and further evidence of AstraZeneca’s commitment to invest in distinctive science in our core therapy areas, with a particular focus on high unmet need. We feel olaparib has real potential to significantly improve treatment decisions for this group of patients who currently have limited options, and to become the next important product in our growing oncology portfolio.”
BRCA1 and BRCA2 are human genes that belong to a type of genes known as tumour suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer and a woman's risk of developing breast and/or ovarian cancer is greatly increased if she inherits a BRCA1 or BRCA2 mutation. Only 15 per cent of ovarian cancers are found before the cancer has spread outside the ovary. Despite advances in treatment and diagnosis, for patients with ovarian cancer that has spread beyond the ovary the five-year survival rate is well below 50 per cent.
Olaparib is an innovative, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor that has been shown in pre-clinical models to exploit DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies. PARP is associated with a range of tumour types, in particular with breast and ovarian cancers.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.