SGO 2020: Phase III Data Support Benefit of Niraparib in Ovarian Cancer
Posted: Friday, April 24, 2020
Results of the phase III PRIMA/ENGOT-OV26/GOG-3012 trial support a clinical benefit for the PARP inhibitor niraparib in women with newly diagnosed advanced ovarian cancer that responded completely or partially to first-line platinum-based chemotherapy. These key secondary endpoint outcomes were made available as part of the virtual platform of the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (Abstract 32).
Sileny N. Han, MD, PhD, of University Hospitals Leuven, Belgium, and colleagues explained that the double-blind trial randomly assigned 733 patients (2:1) to maintenance niraparib or placebo once daily for 36 months or until disease progression. The cohort included some patients with advanced primary peritoneal or fallopian tube cancer. One secondary endpoint, the median time from chemotherapy initiation to first subsequent therapy, was significantly longer in the niraparib arm (18.6 vs. 12.0 months; P = .0001). This benefit was even more pronounced in the subgroup of patients with homologous recombination deficient (HRD) tumors; for them, the median time from chemotherapy initiation to first subsequent therapy was not reached with niraparib, compared with 13.7 months with placebo (P < .0001).
Another secondary endpoint was the time to second objective disease progression. Although significant differences among those receiving niraparib versus placebo were not observed in either the entire population or the HRD-positive or HRD-negative group, the hazard ratio estimates for this measurement were all less than 1. The primary endpoint of progression-free survival, reported previously, also supported niraparib’s benefit, noted Dr. Han and co-investigators.
Disclosure: The study authors’ disclosure information can be found sgo.confex.com.
