Dr Crane on the PRIMA Trial of Niraparib Maintenance Therapy in Ovarian Cancer

Erin K. Crane, MD, MPH, associate professor, Division of Gynecologic Oncology, Atrium Health Levine Cancer Institute, discusses the impact of the phase 3 PRIMA trial (NCT02655016) evaluating second-line maintenance approaches in ovarian cancer.

The randomized phase 3 trial investigated the efficacy of niraparib (Zejula) as a maintenance treatment for all-comer patients with stage III/IV ovarian cancer who had undergone upfront maintenance treatment following frontline platinum-based chemotherapy, Crane begins. Patients were randomly assigned to receive either niraparib or placebo, irrespective of their BRCA mutation status or homologous recombination deficiency (HRD) status, though they were stratified accordingly, she details.

Findings from PRIMA supported the FDA's approval of the maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy on April 29, 2020, Crane reports.

PARP maintenance therapy showed benefits across all subgroups, with the most substantial improvements in progression-free survival (PFS) observed in patients with BRCA-positive or HRD-positive tumors, Crane states. The median PFS in the homologous recombination deficient population was 21.9 months with niraparib compared with 10.4 months for those receiving placebo (HR, 0.43; 95% CI, 0.31-0.59; P < .0001). The median PFS in the overall population was 13.8 months with niraparib compared with 8.2 months for those receiving placebo (HR, 0.62; 95% CI, 0.50-0.76; P < 0.0001). Patients with homologous recombination-proficient tumors also experienced modest PFS improvements, Crane adds.

Notably, the FDA restricted niraparib’s second-line maintenance indication to patients with recurrent platinum-sensitive ovarian cancer harboring deleterious or suspected deleterious germline BRCA mutations in 2022 based on updated data from the phase 3 ENGOT-OV16/NOVA trial (NCT01847274). The decision to use niraparib underscores the importance of personalized treatment approaches and discussions between clinicians and patients regarding the use of PARP maintenance therapy in specific patient populations, Crane concludes.