A Phase II trial showed that Olaparib significantly extends progression-free survival of participants with SOC (platinum-sensitive relapsed serous ovarian cancer) who had completed chemotherapy. Makers AstraZeneca are presenting their findings at the ASCO (American Society of Clinical Oncology) 2011 annual meeting (abstract #5003).
In the Trial, olaparib 400mg twice daily extended PFS (progression free survival) by nearly four months more than a placebo (8.4 compared to 4.8 months). The study participants, all 265 of them with ovarian cancer, had received at least two platinum regimens and were in a partial/complete response after their last platinum regimen. This was a Phase II, randomized, double-blind, multi-center, placebo-controlled study.
As far as the Trial’s secondary endpoint was concerned – TTP (time to progression) – results were also encouraging. Olaparib TTP was 8.3 months, compared to 3.7 in the placebo group.
Adverse events were more common in the olaparib group than in the placebo group and included nausea, fatigue, vomiting and anemia. They were classed as CTAE (Common Terminology Criteria for Adverse Events) grades 1 or 2.
Dr. Jane Robertson, Medical Science Director, AstraZeneca:
“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.”
Olaparib (AZD2281 / KU-0059436) is being currently investigated for some types of breast and ovarian cancers. It is an investigational Poly ADP ribose polymerase (PARP) inhibitor. PARP, an enzyme, is crucial for cancer cell repair – without it they become more damaged and die.
Approximately 22,000 females in the USA were diagnosed with ovarian cancer last year. Ovarian cancer kills about 13,500 women in America each year. Between two-thirds to three-quarters of ovarian cancers are diagnosed as the most aggressive forms, because they are detected at stage III or later.
Written by Christian Nordqvist