Niraparib: A Review in Ovarian Cancer.

Area of Science:

• Oncology
• Pharmacology

Background:

• Niraparib (Zejula®) is a poly (ADP-ribose) polymerase (PARP) inhibitor.
• It is approved for maintenance treatment in recurrent ovarian, fallopian tube, or primary peritoneal cancer following platinum-based chemotherapy.

Purpose of the Study:

• To evaluate the efficacy and safety of niraparib as maintenance therapy in the phase III NOVA trial.
• To assess progression-free survival (PFS) and other efficacy endpoints in patients with recurrent, platinum-sensitive ovarian cancer.

Main Methods:

• Randomized, double-blind, placebo-controlled phase III trial (NOVA).
• Patients with recurrent, platinum-sensitive, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer received niraparib or placebo.
• Primary endpoint was progression-free survival.

Main Results:

• Niraparib significantly prolonged progression-free survival compared to placebo.
• Beneficial effects were observed irrespective of BRCA mutation or homologous recombination deficiency (HRD) status.
• The most common grade 3/4 adverse events were hematologic abnormalities, manageable with dose adjustments.

Conclusions:

• Niraparib is an effective maintenance treatment for recurrent, platinum-sensitive ovarian cancer.
• It offers benefits to patients with or without BRCA mutations or HRD.
• Niraparib presents a manageable tolerability profile for this patient population.