Olaparib moves to Phase III for Ovarian Cancer

AstraZeneca has announced enrolment of 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).

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.