Phase II Study Results Evaluating Effect of Olaparib on Progression Free Survival in Serous Ovarian Cancer Announced Today.
In this phase II, randomised, double-blind, multicenter, placebo-controlled study, olaparib 400 mg twice daily significantly extended progression free survival (PFS) by RECIST (HR=0.35; 95% CI=0.25-0.49; p<0.00001) compared to placebo Median PFS: 8.4 vs 4.8 months respectively. The study evaluated 265 patients who had received two or more previous platinum regimens and who were in a partial or complete response following their last platinum-containing regimen.
Olaparib also significantly prolonged the secondary endpoint of time to progression (TTP) by CA-125 or RECIST (HR=0.35; 95% CI=0.25-0.47; p<0.00001) Median TTP 8.3 vs 3.7 months respectively. Overall survival (OS) data at the time of data cut off were too immature for analysis.
The majority of adverse events (AEs) were CTCAE grade 1 or 2. AEs more commonly reported with olaparib than placebo included nausea (68% vs 35%), fatigue (49% vs 38%), vomiting (32% vs 14%) and anemia (17% vs 5%).
"These results are encouraging as they suggest that olaparib may have a positive effect on PFS in women with serous ovarian cancer, and may be a valuable therapeutic option for this aggressive form of cancer," said Dr. Jane Robertson, Medical Science Director, AstraZeneca.
The full study data will be presented by principal investigator, Professor J.A. Ledermann during an oral presentation at the forthcoming ASCO 2011 annual medical meeting (abstract #5003).
NOTES TO EDITORS:
Olaparib (AZD2281 / KU-0059436) is an investigational Poly ADP ribose polymerase (PARP) inhibitor being evaluated in phase II clinical studies for the treatment of certain types of ovarian and breast cancer. PARP is an enzyme that is important for repairing DNA damage in cells. In cancers that have deficient DNA repair pathways, inhibiting PARP can lead to extensive DNA damage and cell death.
About olaparib study programme
In January 2011, AstraZeneca announced that the initial focus of a potential phase III program would be in serous ovarian cancer. AstraZeneca is still committed to development opportunities in breast cancer and other tumours and will review future development activities once a decision around progression with a phase III programme in serous ovarian cancer has been taken. A second Phase II ovarian cancer study (study 41, olaparib in combination with carboplatin/paclitaxel followed by maintenance olaparib treatment for patients with platinum sensitive SOC) is expected to report in late 2011 and a decision will be based on all of the available data.
About serous ovarian cancer
An estimated 22,000 US women were diagnosed with ovarian cancer in 2010, and more than 13,500 women were estimated to have died of this disease.(i) Approximately 60 to 80 percent of all ovarian cancer cases are diagnosed as the serous ovarian cancer subtype, which is the most aggressive form of the disease.(ii) More than 75 percent of serous ovarian cancer cases are detected at a late stage (stage III or later).(ii)
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me[TM] Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
(i) American Cancer Society. Cancer Facts & Figures 2010. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-026238.pdf. Accessed April 28, 2011. (ii) Levanon K, Crum C, Drapkin R. New Insights into the Pathogenesis of Serous Ovarian Cancer and Its Clinical Impact. J Clin Oncol. 2008;26(32):5284-5293.
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|Article Type:||Clinical report|
|Date:||May 18, 2011|
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