NICE has recommended olaparib for use within the Cancer Drugs Fund as an option for the maintenance treatment of BRCA mutation positive, advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy.
The clinical evidence for olaparib comes from the SOLO 1, double-blind, randomised clinical trial comparing the treatment with placebo in people with newly diagnosed FIGO stage 3 or 4, BRCA mutation-positive advanced ovarian cancer after first-line platinum-based chemotherapy.
At 50.6% data maturity, the median progression-free survival was 13.8 months in the placebo arm and has not been reached in the olaparib arm but the company estimates it to be at least three years longer than placebo (hazard ratio [HR] 0.30; 95% CI 0.23-0.41).
Overall survival was a secondary endpoint in SOLO 1. There was a small non-statistically significant benefit for olaparib compared with placebo, but at 21% maturity, the median was not reached in either arm (HR 0.95; 95% CI 0.60-1.53).
In another study (Study 19) examining olaparib for relapsed ovarian cancer, 10% of patients are disease free after 10 years, indicating cure. These ‘super responders’ are more likely to be people who had a complete response to platinum-based chemotherapy and, because a complete response is more likely at an earlier stage of the disease, the results from SOLO 1 are expected to be very favourable.
“If olaparib increases the length of time people live, it has the potential to be cost-effective, but more evidence from the ongoing trial is needed to address the uncertainties. Therefore, it is recommended for use in the Cancer Drugs Fund, while further data are collected,” NICE concluded.