Dr. Mirza on Niraparib Efficacy Across Ovarian Cancer Subgroups

Mansoor Raza Mirza, MD, chief oncologist at Rigshospitalet, Copenhagen, Denmark, discusses the efficacy of niraparib as a treatment of patients with ovarian cancer.

In the phase III NOVA trial, patients were randomized in a 2:1 ratio across 2 independent cohorts. In the first cohort, patients with germline BRCA mutations received the PARP inhibitor niraparib at 300 mg daily or placebo. In the second cohort, patients with non-germline BRCA-mutant tumors received the agent or placebo. After a median follow-up of 16.9 months, the median progression-free survival (PFS) with niraparib was 21 months compared with 5.5 months for placebo in patients with germline BRCA mutations.

In the study, Mirza and his colleagues performed a subgroup analysis to look at homologous recombination deficiency (HRD) in this population. They found that there were clinically meaningful benefits for both HRD-positive and HRD-negative patients, respectively.

Mirza also notes that approximately one-fifth of patients continued treatment with niraparib at the end of the study follow-up and showed no signs of disease progression.

These findings show that, regardless of BRCA or HRD status, the entire patient population in this study benefited from treatment with niraparib. Coupled with the agent's demonstrated PFS benefit, niraparib represents a novel efficacious treatment approach in ovarian cancer.

In December 2016, on the basis of these favorable results, the FDA granted a priority review to a new drug application for niraparib for use as a maintenance therapy in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy.