Phase 3 Efficacy and Safety of Niraparib in BRCA+ Ovarian Cancer

Kathleen Moore, MD, director of the Oklahoma TSET Phase 1 Program and associate professor in the section of gynecologic oncology at the College of Medicine at the University of Oklahoma, discusses the safety and efficacy profile of niraparib (Zejula), based on data from the phase 3 trials, PRIMA; (NCT02655016), ENGOT-OV16/NOVA (NOVA; NCT01847274), and NORA (NCT03705156), which were presented during the American Society of Clinical Oncology (ASCO) Annual Meeting 2021.

According to Moore, the key takeaway is that there is not much of a difference in the safety profile of niraparib if it is used in the first-line setting versus the second-line setting. As with most PARP inhibitors, the most common adverse events (AEs) are hematologic and gastrointestinal. Thrombocytopenia was the most common hematologic AE, though it declined with individualized dosing. Grade 3 or higher anemia occurred in approximately 25% of patients. Fatigue and nausea were also observed in patients treated with niraparib during the study.

However, according to Moore, through preventative medications and setting certain expectations for patients, these AEs tend to be controllable. Efficacy was also consistent across the studies, especially in patients with BRCA-mutated ovarian cancer.