Niraparib (Zejula™) is a selective poly(ADP-ribose) polymerase 1/2 inhibitor (PARPi) approved for maintenance therapy in adults with recurrent OC who are in response to platinum-based therapy. Here, we report safety and efficacy of niraparib in the subgroup of pts from the ENGOT-OV16/NOVA trial who were aged ≥65 years (y).
Pts were assigned to one of two independent cohorts based on germline BRCA mutation (gBRCAmut) status and randomized 2:1 within each cohort to receive either niraparib (300 mg) or placebo once daily. Pts were stratified by age (
Efficacy of niraparib was comparable in pts
Niraparib was safe and highly effective in elderly patients.
Clinical trial identification
Legal entity responsible for the study
A.V. Tinker: Consulting or Advisory Role: AstraZeneca. S. Mahner: Consulting: Roche, Clovis, Sensor Kinesis, MEDAC, AstraZeneca; Grants from: Roche, PharmaMar, Tesaro, MEDAC, AstraZeneca; Honoraria/reimbursement from: Roche, PharmaMar, Clovis, Tesaro, Sensor Kinesis, MEDAC, AstraZeneca. S. Banerjee: Travel, Accommodations, Expenses: AstraZeneca, Clovis Oncology. R.M. Wenham: Honoraria: Genentech, Janssen, Tesaro; Speakers\' Bureau: Genentech, Janssen; Research Funding: Merck. D.M. Provencher: Consulting: AstraZeneca; Speakers\' Bureau: AstraZeneca. I. Palacio Vázquez: Research Funding: Novartis, Tesaro; Expert Testimony: AstraZeneca; Travel, Accommodations, Expenses: PharmaMar, Roche. M.R. Mirza: Consulting or Advisory Role: Clovis Oncology, AstraZeneca, Tesaro. S.J. Hazard: Employment: Tesaro; Stock: Tesaro. U.A. Matulonis: Consulting/Advisory: Merck KGaA, AstraZeneca, Immunogen, Tesaro, Genentech. All other authors have declared no conflicts of interest.