Results from the ENGOT-OV16/NOVA trial: efficacy and safety of niraparib in ovarian cancer

Dr Mansoor Mirza, chief oncologist at Copenhagen University Hospital, Denmark and medical director of the Nordic Society of Gynaecological Oncology (NSGO) describes the results of the NOVA trial, evaluating the efficacy and safety of the PARP inhibitor, niraparib, as maintenance therapy in patients with recurrent ovarian cancer, who respond to platinum-based chemotherapy. Patients were assigned to cohorts by BRCA mutation status and randomised 2:1 to receive niraparib 300 mg or placebo once daily. The trial included 553 patients, of whom 203 had the germline BRCA mutation and 350 did not. Niraparib significantly improved the primary endpoint of progression-free survival compared to placebo in both cohorts, as well as in all subgroups. Other significant reports are that patients on niraparib maintained symptom control and had a quality of life comparable to those on placebo.

There are limited treatment options for patients with recurrent ovarian cancer; according to Dr Mirza, “This is a breakthrough for patients… we have never seen such large benefits in progression-free survival in recurrent ovarian cancer. These landmark results could change the way we treat this disease.” He concluded that, “Once it is approved by the regulatory authorities, I’ll consider niraparib for all my patients with recurrent ovarian cancer who respond to platinum regardless of BRCA status.”

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