SOLO-1
The evidence for LYNPARZA in high-grade epithelial ovarian cancer comes from three studies: SOLO-1, SOLO-2 and Study 19.7,13,14
First-line maintenance treatment with LYNPARZA tablets is supported by data from the SOLO-1 study.7
About the SOLO-1 study design7
SOLO-1: A landmark study in newly diagnosed BRCAm ovarian cancer
SOLO-1 demonstrates unprecedented efficacy in this setting, with 60% of women with BRCAm advanced ovarian cancer who received LYNPARZA progression-free at 3 years vs 27% of placebo-treated patients.7
SOLO-1: Improved progression free survival in women with BRCAm advanced ovarian cancer7
Adapted from Moore K, et al. 2018.
- At a median follow-up of 41 months, median PFS was not reached in the LYNPARZA treatment group vs. 13.8 months for placebo7
- A sensitivity analysis of PFS using Blinded Independent Central Review (BICR) was consistent with the primary endpoint, with median PFS not reached with LYNPARZA treatment vs. 14.1 months for placebo (data maturity, 38%; HR=0.28 95% CI: 0.20, 0.39; p<0.001)7,15
Adapted from Moore K, et al. 2018. Oral presentation LBA7_PR, ESMO.
* Nominal p values are used for TFST and TSST because these were not controlled for multiplicity throughout the trial
- An interim analysis for overall survival demonstrated that this is not yet suffciently mature to provide meaningful statistical analysis (maturity 21%)7
~9 OUT OF 10
WOMEN
Remained on Lynparza tablets without an adverse events related discontinuation
~7 OUT OF 10
WOMEN Remained on the full recommended dose
Please see safety information for full details on dose interruption, reductions and treatment discontinuation in SOLO-1.