Today at the Society of Gynecologic Oncology (SGO) 43rd Annual Meeting on Women's Cancer®, Dr. Jonathan Ledermann, Director of Cancer Services and Professor of Medical Oncology at University College London, presented new data updating the overall survival of women enrolled in a "Phase II randomized placebo-controlled study of olaparib (AZD2281) maintenance in patients with platinum-sensitive relapsed serous ovarian cancer."
This randomized double-blind, multicenter, placebo-controlled study evaluated maintenance treatment with the PARP inhibitor, olaparib 400 mg twice daily, in patients with platinum sensitive relapsed disease. Patients had received greater than or equal to 2 previous platinum regimens and had a complete response or maintained partial response after their last platinum containing regimen.
When this study was reported at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2011, there was a significant improvement in progression free survival (PFS) after randomization in the olaparib group as compared to placebo, median 8.4 months versus 4.8 months, HR 0.35 (95% CI 0.25-0.49, p<0.00001).
At the SGO's Annual Meeting on Women's Cancer, Dr. Ledermann reported an interim analysis that shows no difference in overall survival. The median overall survival in the olaparib group was 29.7 months as compared to 29.9 months in the placebo group. It should be noted that these data are not yet mature as deaths had occurred in 38% of patients. Dr. Ledermann stated that at the time of analysis 21% of patients receiving olaparib remain on study as compared to only 3% of patients receiving placebo.
These results will be reported on-line in the New England Journal of Medicine today.
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