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E-Poster Display

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


17 Sep 2020


E-Poster Display


Giorgio Valabrega


Annals of Oncology (2020) 31 (suppl_4): S551-S589. 10.1016/annonc/annonc276


G. Valabrega1, B. Pothuri2, A. Oaknin3, W. Graybill4, A.B. Sánchez5, C. Mccormick6, J. Baurain7, P. Hoskins8, H. Denys9, R.E. O’Cearbhaill10, S. Heitanen11, R.G. Moore12, A.Ø. Knudsen13, T. de La Motte Rouge14, F. Heitz15, T. Levy16, Y. Li17, D. Gupta18, B.J. Monk19, A. González Martín20

Author affiliations

  • 1 Department Of Oncology, FPO-IRCCS Candiolo Cancer Institute, Candiolo, Italy and Univeristy of Torino, 10060 - Torino/IT
  • 2 Gynecologic Oncology Group (gog) And Department Of Obstetrics/gynecology, Perlmutter Cancer Center, NYU Langone Health, 10016 - New York/US
  • 3 Medical Oncology, Vall d'Hebron University Hospital and Vall d´Hebron Institute of Oncology (VHIO), 8035 - Barcelona/ES
  • 4 Obstetrics And Gynecology, Medical University of South Carolina, Charleston/US
  • 5 Medical Oncology Department, Unit of Genetic Counseling in Cancer, Hospital General Universitario de Elche, Elche/ES
  • 6 Gynecologic Oncology, Legacy Medical Group, 97210 - Portland, Or/US
  • 7 Medical Oncology, Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, brussels/BE
  • 8 Medical Oncology, British Columbia Cancer Agency, V5Z 1L3 - Vancouver/CA
  • 9 Medical Oncology Department, Ghent University Hospital, 9000 - Gent/BE
  • 10 Department Of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York/US
  • 11 Department Of Obstetrics And Gynecology, Turku University Hospital, Turku/FI
  • 12 Department Of Obstetrics And Gynecology, Wilmot Cancer Institute, University of Rochester, Rochester/US
  • 13 Oncology Department, Odense University Hospital, 5000 - Odense/DK
  • 14 Medical Oncology, Eugene Marquis Cancer Center, 35042 - Rennes/FR
  • 15 Department Of Gynecology, AGO Study Group and Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin/DE
  • 16 Department Of Obstetrics And Gynecology, Wolfson Medical Center, Sackler School of Medicine, Tel Aviv University, Holon/IL
  • 17 Clinical Science, GlaxoSmithKline, waltham/US
  • 18 Clinical Science, GlaxoSmithKline, Waltham/US
  • 19 Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Phoenix/US
  • 20 Medical Oncology Department, Clinica Universidad de Navarra and Grupo Español de Investigación en Cáncer de Ovario (GEICO), 28027 - Madrid/ES


Abstract 819P


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.


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.


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.


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

Safety population Niraparib Placebo
<65 yo n=294 ≥65 yo n=190 <65 yo n=145 ≥65 yo n=99
Any-grade TEAE, n (%)
Thrombocytopenia eventa Anemia eventb Neutropenia eventc 187 (64) 185 (63) 126 (43) 134 (71) 126 (66) 79 (42) 8 (6) 21 (14) 13 (9) 4 (4) 22 (22) 6 (6)
Grade ≥3 TEAE, n (%)
Thrombocytopenia eventa Anemia eventb Neutropenia eventc 101 (34) 98 (33) 60 (20) 87 (46) 52 (27) 40 (21) 0 1 (1) 2 (1) 1 (1) 3 (3) 1 (1)

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


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.


GlaxoSmithKline, Waltham, MA, USA.


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.

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