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PRIME study design

In PRIME (a confirmatory phase III trial), ZEJULA demonstrated efficacy in the ITT population and across secondary and exploratory patient subgroups1

PRIME assessed ZEJULA maintenance in advanced ovarian cancer patients in China who responded to 1L platinum-based chemotherapy1

NA NA

*There was no histological restriction for patients carrying gBRCA mutations.1
†The HRd subgroup consisted of patients with a gBRCA mutation and/or tumour with HRd;1
‡HRd was defined as the presence of a gBRCA mutation and/or tumour with HRd; the other statuses were grouped as HRp.1

The PRIME study sponsored by Zai Lab (Shanghai) Co. was conducted in China, using independently manufactured niraparib capsules. The Zai Lab niraparib capsule has the same formulation composition as GSK’s

ZEJULA capsule, with limited in vitro bioequivalence data available. Care should be taken when interpreting results due to possible differences between products, patient populations and standard of care. Cross-trial comparisons cannot be made.2,3

Caution: direct comparisons across independent studies (e.g., PRIMA & PRIME) are invalid due to heterogeneity in trial populations. Caution should be exercised in interpreting these data. It should also be noted that different biomarker status testing methods were used in each study.

PRIME enrolled a different patient population to the PRIMA trial1-4

Of patients in the ITT population in PRIME (N=384):1

figure showing percentages of patients in PRIME who underwent optimal resection (77.6%), had stage 3 disease (71.9%) or received neoadjuvant chemo (46.9%)

DISCOVER PRIME PFS RESULTS

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PRIME study design

PRIME safety profile

ZEJULA QoL

ZEJULA (niraparib) is indicated2

  • 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.

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; 1L, First line.

References

  1. Li N, et al. Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer A Phase 3 Randomized Clinical Trial. JAMA Oncol;2023;9;1230-1237
  2. ZEJULA (niraparib). Summary of product characteristics. (Last Accessed: May 2024)
  3. Gonzàlez-Martín A, et al. N Engl J Med 2019;381(25):2391–2402
  4. GSK, Inc. Data on file. March 13, 2020. 2020N435433_00

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)