Abstract
Olaparib is a poly ADP-ribose polymerase inhibitor that induces synthetic lethality in tumors with deficient homologous recombination repair. Population exposure-response analyses were performed to evaluate the efficacy and safety of olaparib exposure in patients with cancer. Data from multiple phase I/II/III clinical studies from both capsule and tablet formulations were combined for efficacy (N=410) and safety (N=757) analyses. Exposure-progression-free survival (Cox proportional hazards model indicated that a 300mg b.i.d. tablet was statistically superior to the 200mg b.i.d. tablet dose (hazard ratio of 0.96), although the difference was small. Exposure-safety logistic regression models and hemoglobin models predicted similar probability of safety events or hemoglobin decrease with largely overlapping 95% confidence intervals at 300mg b.i.d. tablet, 200mg b.i.d. tablet, and 400mg b.i.d. capsule. The analyses provided key assessments to support the approval of olaparib 300mg tablet therapeutic dose in patients with ovarian and breast cancer, regardless of their breast cancer (BRCA) mutation status.
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