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PRIME Study Overview

Discover the safety profile of ZEJULA (niraparib) in the PRIME clinical trial1

For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for Zejula

PRIME SAFETY PROFILE

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PRIME REPORTED TEAEs

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PRIME assessed ZEJULA (niraparib) as a 1L maintenance treatment in patients in China who responded to 1L platinum-based chemotherapy1

A randomised, double-blind, placebo-controlled phase III trial, in which all patients received an individualised starting dose1

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.

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PRIME study design

PRIME efficacy

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.

Footnotes

†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

Abbreviations

AE, adverse event; BICR, blinded independent central review; BRCA, breast cancer susceptibility gene; gBRCA, germline BRCA; CR, complete response; FIGO, Federation of Gynaecology and Obstetrics; HRD, homologous recombination deficiency; HRp, homologous recombination proficient; kg, kilogram; mg, milligrams; OS, overall survival; PFS, progression-free survival; PR, partial response; TEAE, treatment-emergent adverse event; TFST, time to first subsequent anti-cancer therapy; μl, microlitre. 1L, First Line.

Reference

  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).

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.

©2024 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

May 2024 | PM-GB-NRP-WCNT-220021 (V2.0)