Efficacy and safety of niraparib in older patients with advanced ovarian cancer (OC): results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Objective To assess the efficacy and safety of niraparib from older patients enrolled in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016).

Materials and methods This double-blind, placebo-controlled phase 3 trial evaluated niraparib in patients with newly diagnosed, advanced, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy. Patients were randomized 2:1 to receive either a fixed starting dose (FSD) of 300 mg niraparib or placebo QD. A protocol amendment introduced an individualized starting dose (ISD): 200 mg QD in patients with bodyweight < 77 kg or platelet count < 150,000/µL or 300 mg QD for all others. Here, patients were dichotomized by age group < 65 vs ≥65 years old (yo) to analyze efficacy and safety of niraparib vs placebo in older patients. The primary endpoint was PFS assessed by blinded independent central review.

Results Of 733 enrolled patients, 444 were < 65 yo (297 niraparib, 147 placebo), and 289 were ≥65 yo (190 niraparib, 99 placebo). Efficacy was comparable in patients < 65 yo (HR 0.61; 95% CI 0.47-0.81) and ≥65 yo (HR 0.53; 95% CI 0.39-0.74) who received niraparib compared with placebo. Safety data by age group, older patients who received FSD/ISD, and patient-reported outcomes will be presented.

Summary Niraparib efficacy, safety, and QOL were similar in compared age groups. Implementation of an ISD regimen improved rates of grade ≥3 thrombocytopenia events in older patients.

Sponsor GlaxoSmithKline, Waltham, MA, USA

Interessenkonflikt

F. Heitz reports non-financial support from NewOncology during the conduct of the study; and personal fees from Roche, AstraZeneca, Clovis, Tesaro, and PharmaMar outside the submitted work. G. Valabrega has nothing to disclose. B. Pothuri reports grants, personal fees and non-financial support from Tesaro; and has been a compensated Advisory Board member for AstraZeneca and Clovis Oncology outside the submitted work. A. Oaknin reports consulting and honoraria fees from AstraZeneca, Tesaro, Clovis, PharmaMar and Roche outside the submitted work. W. Graybill reports personal fees from TESARO outside the submitted work. A. B. Sanchez report speaker fess from AstraZeneca; advisory role at Tesaro; speaker fees from GSK and PHARMAMAR; speaker, travel and accommodation fees from Roche; and travel and accommodation fees from MSD outside the submitted work. C. McCormick has nothing to disclose. J. F. Baurain has nothing to disclose. P. H. Hoskins reports personal fees from AstraZeneca, GSK, and Roche outside the submitted work. H. Denys reports consulting or advisory role at Pfizer, Roche, PharmaMar, AstraZeneca, Eli Lilly, Novartis, Amgen and Tesaro; research funding from Roche; travel, accommodations and expenses from Pfizer, Roche, PharmaMar and Teva outside of the submitted work. R. O’Cearbhaill reports personal fees from Tesaro and GlaxoSmithKline; and grants from NIH/NCI Cancer Center outside the submitted work. S. Hietanen has nothing to disclose R. Moore reports personal fees from Fujirebio Diagnostics Inc, Abcodia Inc, and Humphries Pharmaceutical; and grants from Angle Plc outside of the submitted work. A. O. Knudsen has nothing to disclose T. de La Motte Rouge reports personal fees and non-financial support from ASTRAZENECA, MSD, and Roche; personal fees from Clovis Oncology and GlaxoSmithKline; and grants, personal fees, and non-financial support from Pfizer outside the submitted work. T. Levy has nothing to disclose. Y. Li is an employee of GlaxoSmithKline. D. Gupta is an employee of GlaxoSmithKline. B. Monk reports grants and personal fees from Tesaro outside of the submitted work. A. González-Martín reports personal fees and non-financial support from AstraZeneca; grants, personal fees and non-financial support from TESARO: A GSK Company and Roche Holding AG; and personal fees from Clovis Oncology, Merck & Co. Inc., Genmab, INMUNOGEN, Pharma Mar, and Oncoinvent AS outside the submitted work.

Publication History

Article published online:
07 October 2020