Rucaparib is a PARP inhibitor drug used as an anti-cancer agent, mainly as a third-line treatment for BRCA-mutated ovarian cancer. This objective of this study is to investigate the efficacy and safety of rucaparib as the maintenance treatment in patients with platinum-sensitive, recurrent ovarian carcinoma.
This placebo-controlled, randomized, phase 3 trial included a total of 564 patients aged 18 years or older with platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma. The patients were randomly assigned in a 2:1 ratio to rucaparib (n=375) or placebo (n=189). The primary outcome of the study was progression-free survival, along with other exploratory outcomes.
During the median follow-up of 28.1 months, the median chemotherapy-free survival (CFI) was 14.3 months in the rucaparib group and 8.8 months in the placebo. The median time to start of first subsequent therapy (TFST) was 12.4 months vs. 7.2 months, median progression on subsequent therapy or death (PFS2) was 21.0 months vs. 16.5 months, and the median time to start of second subsequent therapy (TSST) was 22.4 months vs. 17.3 months, in the two groups, respectively.
The research concluded that maintenance treatment with rucaparib resulted in a clinically significant delay in exploratory outcomes in patients with platinum-sensitive, recurrent ovarian carcinoma.