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PRIMA progression free survival (PFS)

In PRIMA, ZEJULA (niraparib) significantly prolonged median PFS in the overall population vs placebo1,2

Overall population:

What would 13.8 months’ median PFS mean for your patients?

PFS (INV) in the overall population in PRIMA at 3.5-year median follow-up (ad hoc endpoint, N=733):1*

graph of months vs PFS % showing PFS in the overall population for patients on niraparib vs placebo

*Investigator-assessed PFS is an ad hoc endpoint, based on estimates from the 3.5-year median follow-up Kaplan-Meier curve1
†Censored subjects are indicated by circles

Figure adapted from González-Martín A, et al. 2023.

3.5 year median follow-up HR: 0.66 (95% CI: 0.56–0.79), P<0.001.1

In the primary analysis, at 1.2 years’ median follow-up, ZEJULA met the primary endpoint in the overall population, with 13.8 months’ median PFS vs 8.2 months’ median PFS in patients receiving placebo, HR: 0.62 (95% CI: 0.50—0.76), P<0.001.2

In the primary analysis, PFS by BICR was reported. In the latest analysis, PFS by IA was reported.1,2

Reduction in risk of progression or death remained consistent with the primary analysis1,2

HRd:

What would more than double the estimated 4-year PFS rate vs placebo mean for your HRd patients?

Estimated PFS in HRd patients at 3.5 year median follow up results

PFS (INV) in HRd patients in PRIMA at 3.5-year median follow-up (ad hoc endpoint, n=373):1*

graph of months vs PFS % showing PFS in the HRD population for patients on niraparib vs placebo

*Investigator-assessed PFS is an ad hoc endpoint, based on estimates from the 3.5-year-median follow-up Kaplan-Meier curve.1
†Censored subjects are indicated by circles

Figure adapted from González-Martín A, et al. 2023.

3.5-year median follow-up HR: 0.52 (95% CI: 0.40–0.68)1

In the primary analysis, at 1.2 years’ median follow-up, ZEJULA met the primary endpoint in the overall population, with 21.9 months’ median PFS vs 10.4 months’ median PFS in patients receiving placebo, HR: 0.43 (95% CI: 0.31—0.59), P<0.001.2

In the primary analysis, PFS by BICR was reported. In the latest analysis, PFS by IA was reported.1,2

Find out more

ZEJULA QoL

ZEJULA dosing

PRIMA safety profile

ZEJULA (niraparib) is indicated3

  • 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

BICR, blinded independent central review; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; BRCAwt, BRCA wild-type; CI, confidence intervals; FIGO, Federation of Gynaecology and Obstetrics; HR, hazard ratio; HRd, homologous recombination deficient; HRp, homologous recombination proficient; IA, investigator assessment; PFS, progression-free survival; PR, partial response; INV, Investigator Assessed.

References

  1. Gonzalez-Martin A, et al, European Journal of Cancer, 189 (2023) 112908. doi:10.1016/j.ejca.2023.04.024 González-Martín A, et al. 
    N Engl J Med. 2019;381(25):2391–2402.
  2. Gonzalez-Martin A, et al. N Engl J Med. 2019;381(25):2391-2402
  3. 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)