Results from a Phase 3 clinical trial, SOLO-2, assessing AstraZeneca's (AZN +1%) PARP inhibitor Lynparza (olaparib) as maintenance therapy in ovarian cancer showed a pronounced extension in survival compared to placebo. The data were presented at the Society of Gynecologic Oncology meeting in National Harbor, MD.
The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) versus placebo. Patients receiving Lynparza experienced median PFS of 19.1 months compared to 5.5 months for placebo (p<0.0001). When measured by blinded independent central review, the difference was even more dramatic: 30.2 months vs. 5.5 months (p<0.0001).
The Lynparza cohort also demonstrated a statistically significant benefit in time to second progression or death (p=0.0002) (hazard ratio = 0.50) (median not reached vs. 18.4 months).
The safety profile for participants treated with Lynparza tablets was generally consistent with those observed with the currently approved capsule formulation.
The company plans to work with regulators to make the tablet formulation available to patients as soon as feasible since tablets reduce the pill burden to four/day from 16/day.
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