Niraparib Shows Positive Data, Requires Different Dosing in Ovarian Cancer

Mansoor R. Mirza, MD, chief oncologist at the Department of Oncology in Rigshospitalet-Copenhagen University Hospital in Denmark and medical director of the Nordic Society of Gynaecologic Oncology, discusses the results of the PRIMA study (NCT02655016) of niraparib (Zejula) in patients with advanced ovarian cancer and the evaluation of the starting dose in these patients.

The results of the PRIMA study were positive in all subsets of patients, including patients with BRCA mutations and those with homologous repair deficiencies. Mirza says these positive data served as the rationale for the FDA’s approval of niraparib in the first line setting, regardless of the patient’s mutational status. This is a good option for patients who did not have an available treatment option before.

When the trial began, there was a starting dose of 300 mg of niraparib daily. The investigators were looking at the NOVA trial to find out why only one-fourth of the population was still on 300 mg after 3 months; most of the patients had a dose reduction down to 200 mg or 100 mg of the drug, according to Mirza. They found 2 factors affected the patient’s ability to receive a certain dose of niraparib. One factor was the patient’s body weight and platelet counts. If the patient was less than 77 kg or their counts were under 150,000/µL, they should receive 200 mg daily. If they had higher counts than that or weighed more than that, they would receive 300 mg daily.

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