AstraZeneca initiates phase 3 ovarian cancer trial; reverses $285m charge
AstraZeneca’s phase 3 clinical trial programme for its ovarian cancer drug, olaparib, has begun following the enrolment of the first patient. As a result of the initiation of this programme, the pre-tax impairment charge of US $285 million, which was incurred in December 2011 following the decision not to progress olaparib into phase 3, will be reversed in the third quarter of 2013.
“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.”
Antoine Yver, Vice President and Head of Oncology in AstraZeneca’s Global Medicines Development unit.
The phase 3 clinical trial programme, called SOLO (Study of OLaparib inOvarian cancer), 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.
The initiation of these studies is based on the subgroup analysis by BRCA mutation status of the phase 2 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.
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