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

Progression free survival (PFS) in HRd BRCAwt sub-population

Image of fictitious patient and overview of sub-population efficacy data Image of fictitious patient and overview of sub-population efficacy data
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Reduces risk
of progression or death vs placebo regardless of biomarker status1-3

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Consistent efficacy
across all HRd patients, regardless of BRCA status1-3

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 (n=256) were those with Stage III disease who have had complete cytoreduction (i.e., no visible residual disease) after 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

See the PRIMA efficacy results for HRd BRCAwt patients

Efficacy data in PRIMA

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

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<0.0001

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<0.0001

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

Efficacy in HRd population by BRCA status

This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect.

ZEJULA offered consistent efficacy across all HRd patients, regardless of BRCA status1-3

PFS in the HRd BRCAwt population (N=150)§3,5

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

*Censored subjects are indicated by circles
Figure adapted from Monk BJ, et al. 2020

HR: 0.50 which means

50% icon

reduction in risk of progression or death with ZEJULA vs placebo§2,3,5
(95% CI: 0.31–0.83)

§This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

PFS in the HRd BRCAmut population (N=223)§3,5

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

*Censored subjects are indicated by circles
Figure adapted from Monk BJ, et al. 2020

HR: 0.40 which means

60% icon

reduction in risk of progression or death with ZEJULA vs placebo§2,3,5
(95% CI: 0.27–0.62)

§This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

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.

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Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

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March 2022 | PM-GB-NRP-WCNT-210017 (V1.0)

February 2022 | PM-GB-NRP-WCNT-210016 v1.0