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PRIME Progression-free survival (PFS)

In PRIME, ZEJULA significantly prolonged median PFS in the ITT population vs placebo1

In PRIME, ZEJULA significantly prolonged median PFS in the ITT population vs placebo1

PFS in the ITT population in PRIME at 27.5-month median follow-up (primary endpoint, N=384):1 HR: 0.45 (95% CI: 0.34–0.60), P<0.001

graph of months vs. PFS % showing the PFS for patients on niraparib vs. placebo in the ITT population in the PRIME trial

*Censored subjects are indicated by circles

Figure adapted from Li N, et al. 2023.

  ZEJULA (n=255)
 Placebo (n=129)
PFS (54.4% data maturity)
Events, n (%) 123 (48.2)
 86 (66.7)
mPFS (95% CI), months
 24.8 (19.2-NE)
 8.3 (7.3-11.1)

In PRIME, ZEJULA prolonged median PFS in the HRd population vs placebo1†

†Statistical analyses not reported

PFS in HRd patients in PRIME at 27.5-month median follow-up (secondary endpoint, n=257):1

HR 0.48 (95% CI:0.34-0.68)

graph of months vs. PFS % showing the PFS for patients on niraparib vs. placebo in the HRd population in the PRIME trial

*Censored subjects are indicated by circles.
Figure adapted from Li N, et al. 2023.

  ZEJULA (n=170) Placebo (n=87)
Events, n (%) 75 (44.1)
 57 (65.5)
Median PFS, months (95% CI)
 NR (22.3-NE) 11.0 (8.3-13.8)
  HR: 0.48
(95% CI: 0.34–0.68)

The BGI Genomics HRD assay used in PRIME has not been clinically validated at present; however, it has received CE-IVDD certification. It is not interchangeable with the Myriad myChoice® CDx HRD test, and the HRd subgroup data from PRIME should not be extrapolated to patients defined according to this test.

Find out more

PRIME safety profile

ZEJULA dosing

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; CI, confidence intervals; FIGO, Federation of Gynaecology and Obstetrics; gBRCA, germline BRCA; HR, hazard ratio; HRd, homologous recombination deficient; HRD, homologous recombination deficiency; HRp, homologous recombination proficient; ITT, intention-to-treat; mPFS, median progression-free survival; NE, non-estimable; non-gBRCAm, non-germline BRCA mutation; PD, progressive disease; PFS, progression-free survival; NR, not reached; CE-IVDD, conformité européenne in vitro diagnostic medical device directive; BGI, Beijing Genomics Institute (Shenzhen, China); QoL, Quality of Life.

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.

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