Lynparza Efficacy Highlighted in New Breast Cancer Trial

Improvements in progression-free survival (PFS) with olaparib (Lynparza) over treatment of physician's choice (TPC) remained consistent regardless of baseline tumor burden for patients with HER2-negative breast cancer with a germline BRCA1/2 mutation (gBRCA1/2m), according to an exploratory analysis from the phase III OlympiAD trial presented at the 2018 Miami Breast Cancer Conference (MBCC).

Although not powered to show statistical significance between the groups, in those with one metastatic site (n = 71) the median PFS with olaparib was 8.4 months compared with 4.2 months with TPC (HR, 0.62; 95% CI, 0.35-1.13). In patients with ≥2 metastatic sites (n = 231), the median PFS was 6.5 months with olaparib compared with 3.0 months for TPC, which crossed the barrier for statistical significance (HR, 0.59; 95% CI, 0.43-0.82).

Across the full OlympiAD trial (n = 302), the median PFS was 7.0 months with olaparib and 4.2 months for TPC (HR, 0.58; 95% CI, 0.43-0.80; P <.001). Additionally, olaparib monotherapy also showed significant benefit for key secondary endpoints, including improvements in health-related quality of life (HRQoL). Based on these findings, in January 2018 the FDA approved olaparib as a treatment for patients with HER2-negative, gBRCA1/2m metastatic breast cancer following prior chemotherapy.

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