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PRIMA Study design

PRIMA is a pivotal phase III trial for ZEJULA in 1L maintenance for advanced ovarian cancer1,2

PRIMA is a randomised, double-blind, placebo-controlled phase III trial1,2

Patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer with high-grade serous or endometrioid cancer that have either:

  • Stage III disease with visible residual disease after primary debulking surgery or had received NACT or had inoperable disease
    OR
  • Stage IV disease regardless of surgical timing or had residual disease with or without NACT use
    AND
  • CR or PR following 1L platinum-based chemotherapy

2:1
randomisation
(N=733)

NA

Patients received treatment for 36 months or until disease progression

BICR-assessed co-primary endpoints:

  • Median PFS in patients with HRd ovarian cancer*
  • Median PFS in the overall patient population

Secondary endpoints:

  • OS (key secondary endpoint)
  • TFST, PFS2
  • Patient-reported outcomes

Biomarker status testing
Before enrollment, tumour samples underwent central testing to identify those with HRd (myChoice test, Myriad Genetics)*

Dosing
PRIMA initially employed a fixed starting dose of 300 mg/day (n=473). Following a protocol amendment, 35% of all patients (n=255/733) received an individualised starting dose of either 200 or 300 mg/day based on baseline body weight and/or platelet count2,4

*HRD status assessed using the FDA-approved Myriad myChoice CDx as either BRCAm or GIS+ (GIS ≥42).2

Patients at high risk of progression were well represented in PRIMA1-4

of patients in the overall population in PRIMA (n=733):2-4

inforgraphic showing percentages of patients in PRIMA who were considered high risk based on residual disease post primary debulking surgery (78%), stage IV disease (35%), and neoadjuvant chemo (67%)

*Stage IV disease with visible residual tumour (>0 cm) after primary debulking surgery3

DISCOVER PRIMA PFS RESULTS

Find out more

PRIMA safety profile

ZEJULA QoL

ZEJULA (niraparib) is indicated1

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Footnotes

*Among the 733 patients who underwent randomisation, 3 patients who were randomised to ZEJULA did not receive ZEJULA, and 2 patients who were randomised to placebo did not receive placebo.2
†In PRIMA, HRD status was determined using the FDA-approved Myriad myChoice CDx as either BRCAmut or GIS+ (GIS>42).2 Patients in PRIMA received an individualised starting dose of, either 200 mg or 300 mg, based on their baseline body weight or platelet count (n=255), or a fixed starting dose of 300 mg/day (n=473), regardless of bodyweight or platelet count.3
§Homologous recombination status could not be determined in 111 patients in the PRIMA trial.2

Abbreviations

BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; CR, complete response; FIGO, Federation of Gynaecology and Obstetrics; GIS, genomic instability score; HRd, homologous recombination deficient; HRD, homologous recombination deficiency; PFS, progression-free survival; PR, partial response; QoL, Quality of Life.

References

  1. ZEJULA (niraparib). Summary of product characteristics. (Last Accessed; May 2024)
  2. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. GSK, Inc. Data on file. March 13, 2020. 2020N435433_00.
  4. Gonzalez-Matrin A, et al. presented at ESGO 2019, 2-5 Nov, Athens, Greece

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk (UK) or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GSK Limited on 0800 221 441 or by email at uksafety@gsk.com.

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May 2024 | PM-GB-NRP-WCNT-220019 (V2.0)