738P - Quality-adjusted time without symptom or toxicity (QA-TWiST) and quality-adjusted progression-free survival (QA-PFS) of first-line (1L) maintenance niraparib in patients with advanced ovarian cancer (OC): Results from the PRIMA trial

Background

The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) phase III trial showed niraparib significantly prolongs median PFS vs placebo in patients with advanced OC responsive to 1L platinum (Pt)-based chemotherapy (CT), regardless of biomarker status. This post hoc analysis of PRIMA examined the QA-TWiST and QA-PFS of patients on maintenance niraparib vs placebo.

Methods

Patients with OC responsive to 1L Pt CT were randomised 2:1 to receive once-daily maintenance niraparib or placebo. QA-TWiST analyses were performed, defining TOX as the mean duration in which a patient experienced grade ≥2 adverse events (fatigue or asthenia, nausea, vomiting, abdominal pain, and abdominal bloating) from randomisation to disease progression/censoring. Mean QA-TWiST was calculated as U_TOX x TOX + U_TWiST x TWiST, where U_TWiST and U_TOX represent utilities applied to the time spent in TWiST and TOX health states, respectively. U_TWiST was considered 1.00, i.e., the best possible quality of life for a patient. U_TOX was calculated using EQ-5D index scores from the PRIMA trial. Restricted mean QA-PFS was calculated from the area under the quality-survival product function up to the last PFS of patients randomised to niraparib.

Results

Patient follow-up was 27.8 months. There were significant improvements in mean QA-TWiST for niraparib vs placebo in the intention-to-treat (ITT) and homologous recombination-deficient (HRd) cohorts, with mean gains of 3.5 and 5.9 months, respectively (Table). Similarly, QA-PFS was significantly longer with niraparib vs placebo in these cohorts.

Conclusions

In patients with OC, 1L niraparib maintenance was associated with significant gains in QA-TWiST and QA-PFS vs placebo, confirming the benefit of niraparib in the overall ITT population and HRd cohorts. Table: 738P

Mean QA-TWiST and QA-PFS in ITT and HRd cohorts

Clinical trial identification

NCT02655016.

Editorial acknowledgement

Medical writing support was provided by Nadia Hashash of Core Medica, London, UK, funded by GlaxoSmithKline.

Legal entity responsible for the study

GlaxoSmithKline.

Funding

GlaxoSmithKline (ID: 214211).

Disclosure

M. Barretina-Ginesta: Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: GlaxoSmithKline; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: Pharma Mar; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Other, Lecture fees and travel support: Tesaro; Financial Interests, Personal, Other, Lecture fees and travel support: GlaxoSmithKline; Financial Interests, Personal, Other, Lecture fees and travel support: AstraZeneca; Financial Interests, Personal, Other, Lecture fees and travel support: Roche; Financial Interests, Personal, Other, Lecture fees and travel support: Clovis Oncology; Financial Interests, Personal, Other, Lecture fees and travel support: Pharma Mar; Financial Interests, Personal, Other, Lecture fees and travel support: Merck. B.J. Monk: Financial Interests, Personal, Other, Lecture fees: Tesaro; Financial Interests, Personal, Other, Honoraria: Tesaro. B. Pothuri: Financial Interests, Personal, Research Grant: Tesaro/GSK; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Research Grant: Genentech/Roche; Financial Interests, Personal, Research Grant: Celsion; Financial Interests, Personal, Research Grant: Mersana; Financial Interests, Personal, Research Grant: Clovis Oncology; Financial Interests, Personal, Advisory Board: Tesaro/GSK; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Toray; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: Elevar; Financial Interests, Personal, Advisory Board: Arquer; Financial Interests, Personal, Advisory Board: Eisai. D. Chase: Financial Interests, Personal, Other, Personal Fees: GlaxoSmithKline; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Consultancy fees: Mateon Therapeutics; Financial Interests, Personal, Other, Consultancy fees: AstraZeneca; Financial Interests, Personal, Research Grant: Genentech. D. Lorusso: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: Genmab; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Research Grant: Pharma Mar; Financial Interests, Personal, Other, Consulting Fees: Pharma Mar; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Advisory Board: Merck. A. Redondo: Financial Interests, Personal, Research Grant: Pharma Mar ; Financial Interests, Personal, Advisory Role: Pharma Mar; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Tesaro; Financial Interests, Personal, Research Grant: Eisai. R. Shah: Financial Interests, Personal, Full or part-time Employment: Open Health Evidence and Access. N. Kebede: Financial Interests, Personal, Full or part-time Employment: Open Health Evidence and Access. C. Hawkes: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. D. Gupta: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. T. Woodward: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. D.M. O'Malley: Financial Interests, Personal, Research Grant: Clovis; Financial Interests, Personal, Other, Personal fees: Clovis; Financial Interests, Personal, Advisory Board: Agenus; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Genentech/Roche; Financial Interests, Personal, Advisory Board: Immunogen; Financial Interests, Personal, Advisory Board: Iovance Biotherapeutics; Financial Interests, Personal, Advisory Board: Janssen/Johnson & Johnson; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Mersana; Financial Interests, Personal, Advisory Board: Myriad; Financial Interests, Personal, Advisory Board: Novartis Pharmaceuticals; Financial Interests, Personal, Advisory Board: Novocure; Financial Interests, Personal, Advisory Board: Regeneron Pharmaceuticals; Financial Interests, Personal, Advisory Board: SeaGen; Financial Interests, Personal, Advisory Board: Tarveda; Financial Interests, Personal, Advisory Board: Tesaro/GSK; Financial Interests, Personal, Other, Steering committee: Amgen; Financial Interests, Personal, Other, Consultant: AbbVie; Financial Interests, Personal, Other, Consultant: Agenus; Financial Interests, Personal, Other, Consultant: Ambry; Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Eisai; Financial Interests, Personal, Other, Consultant: Genentech/Roche; Financial Interests, Personal, Invited Speaker, Consultant: GOG Foundation; Financial Interests, Personal, Invited Speaker, Consultant: Immunogen; Financial Interests, Personal, Invited Speaker, Consultant: Iovance Biotherapeutics; Financial Interests, Personal, Invited Speaker, Consultant: Merck; Financial Interests, Personal, Invited Speaker, Consultant: Mersana; Financial Interests, Personal, Invited Speaker, Consultant: Novartis Pharmaceuticals; Financial Interests, Personal, Invited Speaker, Consultant: Novocure; Financial Interests, Personal, Invited Speaker, Consultant: Seagen; Financial Interests, Personal, Invited Speaker, Consultant: Tesaro/GSK; Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant: Agenus; Financial Interests, Institutional, Research Grant: Ajinomoto; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Array BioPharma; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Cerulean Pharma; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: EMD Serono; Financial Interests, Institutional, Research Grant: Ergomed Clinical Research; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Institutional, Research Grant: Genentech/Roche; Financial Interests, Institutional, Research Grant: GOG Foundation; Financial Interests, Institutional, Research Grant: ImmunoGen; Financial Interests, Institutional, Research Grant: INC Research; Financial Interests, Institutional, Research Grant: inVentiv Health Clinical; Financial Interests, Institutional, Research Grant: Iovance Biotherapeutics; Financial Interests, Institutional, Research Grant: Janssen/Johnson & Johnson; Financial Interests, Institutional, Research Grant: Ludwig Institute for Cancer Research; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Mersana; Financial Interests, Institutional, Research Grant: New Mexico Cancer Care Alliance; Financial Interests, Institutional, Research Grant: Novocure; Financial Interests, Institutional, Research Grant: PRA International; Financial Interests, Institutional, Research Grant: Regeneron Pharmaceuticals; Financial Interests, Institutional, Research Grant: Seagen; Financial Interests, Institutional, Research Grant: Serono; Financial Interests, Institutional, Research Grant: Stemcentrx; Financial Interests, Institutional, Research Grant: Tesaro/GSK; Financial Interests, Institutional, Research Grant: TRACON Pharmaceuticals; Financial Interests, Institutional, Research Grant: VentiRx; Financial Interests, Institutional, Research Grant: Yale University. A.J. Gonzalez Martin: Financial Interests, Personal, Other, Consultning fees, lecture fees, travel support: AstraZeneca; Financial Interests, Personal, Other, Consultning fees, lecture fees, travel support: Pharma Mar; Financial Interests, Personal, Other, Grant support, consulting fees, lecture fees, and travel support: Tesaro; Financial Interests, Personal, Other, Grant support, consulting fees, lecture fees, and travel support: Roche Holding; Financial Interests, Personal, Other, Consulting fees: Clovis Oncology; Financial Interests, Personal, Other, Consulting fees: Merck; Financial Interests, Personal, Other, Consulting fees: Genmab; Financial Interests, Personal, Other, Consulting fees: InnunoGen; Financial Interests, Personal, Other, Consulting fees: Oncoinvent. All other authors have declared no conflicts of interest.