A group of researchers have demonstrated that the PARP inhibitor niraparib significantly improves progression-free survival (PFS) in platinum-sensitive recurrent ovarian cancer in a clinical trial, the results of which were published recently in the New England Journal of Medicine.
The results of this randomized, placebo-controlled, Phase III trial were presented at the ESMO 2016 Congress (7–11 October 2016, Copenhagen, Denmark) by Mansoor Raza Mirza from Copenhagen University Hospital (Copenhagen, Denmark) and colleagues.
In the trial, 553 patients were split into two cohorts depending on whether they had a germline BRCA mutation or not. Patients were then randomized 2:1 to receive either a 300 mg dose of niraparib or placebo once daily.
The researchers demonstrated that PFS, chemotherapy-free interval and time to subsequent treatment were all improved for patients receiving niraparib compared with those patients receiving the placebo.
The study results also suggest that niraparib is clinically beneficial regardless of the BRCA-mutation status of patients. Collectively, the group observed a manageable safety profile for this oral drug, with patient reported outcomes being similar in both treatment groups.
Mirza commented on the clinical significance of the groups findings: “This is a breakthrough for patients with ovarian cancer. We have never seen such large benefits in PFS in recurrent ovarian cancer. Niraparib significantly improved all endpoints across a broad patient population representing 70% of all ovarian cancer patients. These landmark results could change the way we treat this disease.”
Researchers believe that future studies should focus on evaluating the factors that may affect a patient’s response to niraparib.
Sources: Mirza M, Monk B, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive recurrent ovarian cancer. N. Engl. J. Med. DOI: 10.1056/NEJMoa1611310; ESMO press release