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LYNPARZA PFS IN BRCA OVARIAN MAINTENANCE THERAPY
LYNPARZA PFS IN BRCA OVARIAN MAINTENANCE THERAPY.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 5120Z AstraZeneca PLC 15 March 2017 \n\n15 March 2017 07:00GMT\n \nLYNPARZA PHASE III SOLO-2 DATA DEMONSTRATE PROGRESSION-FREE SURVIVAL BENEFIT IN BRCA-MUTATED OVARIAN CANCER AS MAINTENANCE THERAPY\n \nLynparza reduced risk of disease progression by 70% with an investigator-assessed progression-free survival of 19.1 months vs 5.5 months with placebo\n \nBlinded independent central review showed impressive progression-free survival of 30.2 months vs 5.5 months with placebo\n \nLynparza tablets demonstrated a safety profile generally consistent with previous studies, including a low incidence of haematological toxicity\n \nAstraZeneca today presented results from the Phase III SOLO-2 trial demonstrating a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza (olaparib) tablets (300mg twice daily) compared with placebo in the maintenance setting. The trial met its primary endpoint of investigator assessed PFS (HR 0.30; 95% CI 0.22 to 0.41; P<0.0001; median 19.1 months vs 5.5 months). \n \nPFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; P<0.0001). \n \nAdditionally, a statistically-significant benefit in time to second progression or death (PFS2) was also seen in patients treated with Lynparza (HR 0.50; 95% CI 0.34 to 0.72; P=0.0002; median not reached vs 18.4 months) compared with placebo, as well as improvements in other key secondary endpoints.\n \nProgression-Free Survival by investigator and BICR assessment:\n \n\n\n\n\nAnalysis\n\n\nMedian progression-free survival, months\n\n\nHazard ratio\n\n\n\n\nInvestigator-assessed analysis\n\n\nLynparza\n\n\n19.1\n \n\n\n0.30 (95% CI, 0.22-0.41), P<0.0001\n\n\n\n\nPlacebo\n\n\n \n5.5\n \n\n\n\n\nBlinded Independent Central Review\n\n\nLynparza\n\n\n \n30.2\n \n\n\n0.25 (95% CI, 0.18-0.35), P<0.0001\n\n\n\n\nPlacebo\n\n\n \n5.5\n \n\n\n\n\n \nThese results, presented at the Society of Gynecologic Oncology Annual Meeting on Women's Can...