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347 Efficacy and safety of niraparib in older patients (PTS) with advanced ovarian cancer (OC): results from the prima/ENGOT-OV26/GOG-3012 trial
  1. Hanna Dahlstrand1,
  2. Bhavana Pothuri2,
  3. Whitney Graybill3,
  4. Thibault de La Motte Rouge4,
  5. Colleen Mccormick5,
  6. Florian Heitz6,
  7. Jean-Francois Baurain7,
  8. LI Yong8,
  9. Bradley J Monk9 and
  10. Antonio González-Martin10
  1. 1Uppsala University; Department of Immunology, Genetics and Pathology
  2. 2Gynecologic Oncology Group (Gog); Perlmutter Cancer Center, Nyu Langone Health; Department of Obstetrics/Gynecology
  3. 3Medical University of South Carolina
  4. 4Eugene Marquis Cancer Center
  5. 5Legacy Medical Group Gynecologic Oncology
  6. 6Ago Study Group; Charité – Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health; Department of Gynecology
  7. 7Université Catholique de Louvain and Cliniques Universitaires Saint-Luc
  8. 8Glaxosmithkline
  9. 9Arizona Oncology (US Oncology Network), University of Arizona College of Medicine
  10. 10Grupo Español de Investigación En Cáncer de Ovario (Geico); Clínica Universidad de Navarra; Medical Oncology Department


Introduction/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.

Methodology This double-blind, placebo (PBO)-controlled phase 3 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 randomised 2:1 to receive either a fixed starting dose (FSD) of 300 mg niraparib or PBO QD. A protocol amendment introduced an individualised 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 analyse 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 1). 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.

Abstract 347 Table 1

Conclusion 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.

Disclosures Funding: GlaxoSmithKline

NCT number: NCT02655016

Encore statement: This data is presented on behalf of the original authors with their permission. Presented at the European Society for Medical Oncology (ESMO) Annual Meeting, September 19–21, 2020, Virtual.

Dr. Dahlstrand reports personal fees from AstraZeneca and Roche.

Dr. Pothuri reports grants, personal fees and non-financial support from GSK; Advisory Board fees from AstraZeneca and Clovis Oncology.

Dr. Graybill reports personal fees from GSK.

Dr. McCormick has nothing to disclose.

Dr. 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.

Dr. Heitz reports non-financial support from NewOncology; Personal fees from Roche, AstraZeneca, Clovis, Tesaro, and PharmaMar.

Dr. Monk reports consulting and advisory role at Merck, GSK, Roche/Genentech, AstraZeneca, Advaxiz, Cerulean Pharma, Amgen, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Perthera, Abbvie, Myriad Pharmaceuticals, Incyte, VBL Therapeutics, Takeda, Samumed, Oncomed, OncoSec, ChemoID, Geistlich Pharma, Eisai and Chemocare; Speakers’ bureau at Roche/Genentech, AstraZeneca, Janssen, Clovis Oncology and GSK; Honoraria from Merck, GSK, Roche/Genentech, AstraZeneca, Advaxis, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Pethera, Abbvie, Myriad Pharmaceuticals, Incyte, Janssen, Amgen, Genmab, Samumed, Takeda, VBL Therapeutics, Puma Biotechnology, Immunomedics, Conjupro Biotherapeutics, Agenus, OncoQuest, ChemoID, Geistlich Pharma, Eisai and Chemocare; and Research funding from Novartis, Amgen, Genentech, Lilly, Janssen, Array BioPharma, GSK, Morphotek, Pfizer, Advaxis, AstraZeneca, Immunogen, Regeneron, and Nucana.

Dr. González-Martín reports personal fees and non-financial support from AstraZeneca; Grant and personal fees from GSK, Clovis Oncology, Roche Holding AG, Merck & Co., Inc., Genmab, INMUNOGEN, Pharma Mar, S.A., and Oncoinvent AS.

Drs Li and Gupta are employees of GlaxoSmithKline.

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