819P - Efficacy and safety of niraparib in older patients (pts) with advanced ovarian cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Background

The PRIMA/ENGOT-OV26/GOG-3012 (PRIMA) trial showed that niraparib significantly improves progression-free survival (PFS) in pts with newly diagnosed advanced OC that responded to first-line platinum-based chemotherapy (CT) (hazard ratio [HR] 0.62; 95% CI 0.50–0.76). Here we discuss the impact of age on efficacy and safety of niraparib.

Methods

This double-blind, placebo (PBO)-controlled phase III trial evaluated niraparib in pts 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 CT. Pts were randomized 2:1 to receive either a fixed starting dose (FSD) of 300 mg niraparib or PBO QD. A protocol amendment introduced an individualized starting dose (ISD): 200 mg QD in pts with bodyweight <77 kg or platelet count <150,000/μL or 300 mg QD for all others. Pts were dichotomized by age group <65 vs ≥65 years old (yo) to analyze efficacy and safety of niraparib vs PBO in older patients. The primary endpoint was PFS assessed by blinded independent central review.

Results

Of 733 enrolled pts, 444 were <65 yo (297 niraparib, 147 PBO), and 289 were ≥65 yo (190 niraparib, 99 PBO). Efficacy was comparable in pts <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 PBO. Any-grade and grade ≥3 treatment emergent adverse events were similar across age groups (Table). Grade ≥3 thrombocytopenia events in pts <65 yo were reported in 43% of pts receiving a FSD and 18% of pts receiving ISD. In pts ≥65 yo, the values were 57% and 26%, respectively. Patient reported outcomes (PROs) and quality of life (QOL) were similar in both age groups as assessed by FOSI and EQ-5D-5L.

Conclusions

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 pts. Table: 819P

^aIncludes thrombocytopenia and platelet count decreased.^bIncludes anemia, hemoglobin decreased, and anemia macrocytic.^cIncludes neutropenia, neutrophil count decreased, and febrile neutropenia.TEAE=treatment-emergent adverse event; yo=years old.

Clinical trial identification

NCT02655016.

Editorial acknowledgement

Writing and editorial support, funded by GlaxoSmithKline (Waltham, MA, USA) and coordinated by Ashujit Tagde, PhD of GlaxoSmithKline, was provided by Eric Scocchera, PhD and Anne Cooper, MA of Ashfield Healthcare Communications (Middletown, CT, USA).

Legal entity responsible for the study

GlaxoSmithKline, Waltham, MA, USA.

Funding

GlaxoSmithKline, Waltham, MA, USA.

Disclosure

G. Valabrega: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: GSK-Tesaro; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: PharmaMar; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Clovis. B. Pothuri: Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Tesaro; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Clovis Oncology. A. Oaknin: Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Tesaro; Honoraria (institution), Advisory/Consultancy: Clovis; Honoraria (institution), Advisory/Consultancy: PharmaMar; Honoraria (institution), Advisory/Consultancy: Roche. W. Graybill: Advisory/Consultancy: Tesaro. A.B. Sánchez: Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Tesaro; Speaker Bureau/Expert testimony: GSK; Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: MSD. P. Hoskins: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK; Advisory/Consultancy: Roche. H. Denys: Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: PharmaMar; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy: Tesaro; Travel/Accommodation/Expenses: Teva. R.E. O’Cearbhaill: Advisory/Consultancy: Tesaro; Advisory/Consultancy: GlaxoSmithKline; Research grant/Funding (institution): NIH/NCI Cancer Center. R.G. Moore: Advisory/Consultancy: Fujirebio Diagnostics Inc.; Research grant/Funding (institution): Angle Plc; Advisory/Consultancy: Abcodia Inc.; Advisory/Consultancy: Humphries Pharmaceutical. T. de La Motte Rouge: Advisory/Consultancy, Non-remunerated activity/ies: AstraZeneca; Advisory/Consultancy, Non-remunerated activity/ies: MSD; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Tesaro GSK; Advisory/Consultancy, Non-remunerated activity/ies: Roche; Advisory/Consultancy, Non-remunerated activity/ies: Pfizer. F. Heitz: Non-remunerated activity/ies: NewOncology; Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Clovis; Advisory/Consultancy: Tesaro; Advisory/Consultancy: PharmaMar. Y. Li, D. Gupta: Full/Part-time employment: GlaxoSmithKline. B.J. Monk: Advisory/Consultancy, Research grant/Funding (institution): Tesaro. A. González Martín: Advisory/Consultancy, Non-remunerated activity/ies: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Tesaro; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Roche Holding AG; Advisory/Consultancy: Merck & Co., Inc.; Advisory/Consultancy: Genmab; Advisory/Consultancy: Immunogen; Advisory/Consultancy: Pharma Mar, S.A; Advisory/Consultancy: Oncoinvent AS. All other authors have declared no conflicts of interest.