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Discover the efficacy of ZEJULA (niraparib) in advanced ovarian cancer in the PRIMA clinical trial1,2

Lower rates icon

Reduces risk
of progression or death vs placebo regardless of biomarker status1-3

VIEW OVERALL POPULATION DATA

PRIMA clinical trial design

Patients at high risk of progression were well represented in the PRIMA clinical trial1,2,4

  • Trial design

    PRIMA was a Phase III trial in advanced ovarian cancer1,2

    The PRIMA/ENGOT-OV26 trial assessed ZEJULA as a first-line maintenance therapy in patients with advanced ovarian cancer in partial or complete response to platinum-based chemotherapy, regardless of biomarker status1,2

    PRIMA study design PRIMA study design

    Ineligible patients were those with Stage III disease who have had complete cytoreduction (i.e., no visible residual disease) after Primary Debulking Surgery (PDS).5

    In PRIMA, HRd status was determined using the FDA-approved Myriad myChoice CDx as either BRCAmut or GIS+ (GIS ≥42).6

    *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 body weight or platelet count.1

    Of patients in the overall population (N=733):

    Proportion of high-risk patients in PRIMA Proportion of high-risk patients in PRIMA

    †Stage III and IV disease with visible residual tumour (>0 cm) after primary debulking surgery.4

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The overall population (N=733) consisted of:‡2,6

Image to display overall population Image to display overall population

‡Homologous recombination status could not be determined in 111 patients in the PRIMA trial.6

Efficacy data in PRIMA

ZEJULA (niraparib) significantly reduced the risk of progression and death vs placebo regardless of biomarker status1-3

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PFS in the overall population (N=733)2

Graph showing PFS in the overall population Graph showing PFS in the overall population

*Censored subjects are indicated by circles
Figure adapted from González-Martin A, et al. 2019

HR: 0.62 which means

38% icon

reduction in risk of progression or death with ZEJULA vs placebo2
(95% CI: 0.50–0.76), P<0.001

PFS in the HRd population (N=373)2

Graph showing PFS in the HRd population Graph showing PFS in the HRd population

*Censored subjects are indicated by circles.
Figure adapted from González-Martín A, et al. 2019.
62% of patients in the HRd population were BRCAmut

HR: 0.43 which means

57% icon

reduction in risk of progression or deathwith ZEJULA vs placebo2
(95% CI: 0.31–0.59), P<0.001

Clinical PFS benefit in the HRp subgroup (n=249, 34% of overall study population) FS in the HRd population (N=373)2,3,5

Graph showing PFS in the HRp population Graph showing PFS in the HRp population

Figure adapted from Monk BJ, et al. 2020

HR: 0.68 which means

32% icon

reduction in risk of progression or death with ZEJULA vs placebo2,3,5
(95% CI: 0.49–0.94)

Discover the safety of ZEJULA

EXPLORE SAFETY OF ZEJULA

Learn more about ZEJULA

Safety

See ZEJULA safety in PRIMA

Dosing

See information about ZEJULA dosing in PRIMA

QoL

See how ZEJULA impacted QoL in PRIMA

ZEJULA is indicated:1

  • 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.

Footnotes

BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; BRCAwt, BRCA wild-type; CI, confidence interval; FDA, Food and Drug Administration; GIS, genomic instability status; HR, hazard ratio; HRd, homologous recombination deficient; HRp, homologous recombination proficient; MoA, mechanism of action; PDS, primary debulking surgery; PFS, progression-free survival; QoL, quality of life.

References

  1. ZEJULA Summary of Product Characteristics.
  2. González-Martín A, Pothuri B, Vergote I, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. Monk BJ, Han S, Pothuri B, et al. Efficacy of Niraparib Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer by BRCA and Homologous Recombination Status: PRIMA/ENGOTOV26/ GOG-3012 Study. Poster presented at the Society of Gynecologic Oncology (SGO) 2020 Webinar Series.
  4. GSK, Inc. Data on file. March 13 2020, 2020N435433_00.
  5. Gonzalez-Martin A, et al. Presented at ESMO 2019. Barcelona, Spain.
  6. Gonzalez-Martin A, et al. N Engl J Med. 2019; 381: 2391–2402. Supplementary appendix. 2020-amended-4521docx-for-website.pdf. Accessed January 2022.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Zejula is a registered trademark of the GlaxoSmithKline group of companies.

December 2022 PM-IE-NRP-WCNT-220021