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Discover the safety of ZEJULA (niraparib) in the PRIMA clinical trial1,2

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Safety profile consistent
with previous clinical trial experience1,2

VIEW MOST FREQUENT AES

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Side effects manageable
with dose interruption and modification3

VIEW AE MANAGEMENT

Lower rates icon

Reduction in adverse events with an individualised starting dose, without compromising efficacy*3-8

VIEW STARTING DOSE & AES

*This analysis is exploratory in nature; it does not control for Type 1 error and is not powered to determine treatment effect in any subgroup.

Reported adverse events (AEs)

The safety and tolerability profile of ZEJULA in PRIMA is consistent with previous clinical trial experience1,2

AEs reported in ≥20% of all patients in PRIMA1

Graph showing AEs reported in patients in PRIMA Graph showing AEs reported in patients in PRIMA

Figure adapted from González-Martin et al. 2019. Numbers above 1 have been rounded to the nearest decimal place.

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Only 12% of patients discontinued treatment with ZEJULA due to AEs.†1
This decreased even further to just 9% of patients in the BRCAmut sub-group.9

†Compared with 2.5% in the placebo group.1 Discontinuation due to thrombocytopenia, anaemia, and neutropenia occurred in 4%, 3%, and 2% of patients, respectively.3

AE management

Side effects with ZEJULA can be managed with dose interruption and modification3

In PRIMA, adverse events led to dose interruptions and dose reductions in 79.5% and 70.9% of patients who received ZEJULA, respectively1

Monitoring complete blood counts and blood pressure will help identify the need to modify dosage of ZEJULA‡3

Infographic showing example of monitoring schedule Infographic showing example of monitoring schedule

This is the recommended minimum requirement for monitoring. Prescribers should monitor as per guidelines and discretion.3

‡Monitor periodically.

Individualised dosing

ZEJULA individualised starting dose demonstrated lower rates of selected AEs vs a fixed starting dose3-8

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Rates of select grades 3-4 haematologic AEs with ZEJULA8

Graph showing rates of 3-4 haematologic AEs Graph showing rates of 3-4 haematologic AEs

Figure adapted from Graybill W et al.8

Overall population receiving individualised starting dose
Progression free survival Individualised Starting dose: HR 0.69 (95% CI 0.48-0.96)
Fixed Starting dose: HR 0.59 (95% CI 0.48-0.76)

This analysis is exploratory in nature; it does not control for Type 1 error and is not powered to determine treatment effect in any subgroup.

§Includes thrombocytopenia and platelet count decreased.8
Includes anaemia and haemoglobin decreased.8
#Includes neutropenia and neutrophil count decreased.8

Rates of select grades 1-4 gastrointestinal AEs with ZEJULA6

Graph showing rates of 1-4 gastrointestinal AEs Graph showing rates of 1-4 gastrointestinal AEs

Figure adapted from Graybill W et al.8

Overall population receiving individualised starting dose
Progression free survival Individualised Starting dose: HR 0.69 (95% CI 0.48-0.96)
Fixed Starting dose: HR 0.59 (95% CI 0.48-0.76)

This analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.

Discover ZEJULA’s individualised starting dose

EXPLORE ZEJULA’S INDIVIDUALISED STARTING DOSE

Learn more about ZEJULA

Efficacy

See ZEJULA efficacy in PRIMA

QoL

See how ZEJULA impacted QoL in PRIMA

Dosing

See information about ZEJULA dosing in PRIMA

ZEJULA is indicated:3

  • 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

AE, adverse event; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; CI, confidence interval; HR, hazard ratio; ISD, individualised starting dose; MoA, mechanism of action; QoL, quality of life.

References

  1. González-Martín A, Pothuri B, Vergote I, et al. N Engl J Med. 2019;381(25):2391-2402.
  2. Freyer G, et al. Presented at IGCS 2020, 10-13 Sep. (virtual).
  3. ZEJULA Summary of Product Characteristics.
  4. Mirza MR, González-Martín A, Graybill W, et al. Evaluation of an individualized starting dose of niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Study. Poster presented at the American Society of Clinical Oncology (ASCO) Congress; 29-31 May 2020. Poster 221.
  5. Korach J, Graybill W, Redondo A, et al. Niraparib in patients with newly diagnosed advanced ovarian BRCAm cancer: a post hoc analysis of the PRIMA/ENGOT-OV26/GOG- 3012 trial. Abstract presented at the European Society of Gynaecological Oncology (ESGO) Congress; 14-16 December 2020. Abstract 571.
  6. GSK, Inc. Data on file. 2020 [list of adverse events by fixed versus individualised starting dose].
  7. GSK, Inc. Data on file. 2020 [Niraparib Global Data Sheet].
  8. Graybill W, et al. Presented at IGCS 2020,10 - 13 Sep. (virtual).
  9. Korach J, et al. Presented at ESGO SoA 2020, Dec 14-16 (virtual).

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.

 September 2024 PM-IE-NRP-WCNT-230001

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