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59
Reduces risk
of progression or death vs placebo regardless of biomarker status1-3
Patients at high risk of progression were well represented in the PRIMA clinical trial1,2,4
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
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
†Stage III and IV disease with visible residual tumour (>0 cm) after primary debulking surgery.4
‡Homologous recombination status could not be determined in 111 patients in the PRIMA trial.6
ZEJULA (niraparib) significantly reduced the risk of progression and death vs placebo regardless of biomarker status1-3
*Censored subjects are indicated by circles
Figure adapted from González-Martin A, et al. 2019
HR: 0.62 which means
reduction in risk of progression or death with ZEJULA vs placebo2
(95% CI: 0.50–0.76), P<0.0001
*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
reduction in risk of progression or deathwith ZEJULA vs placebo2
(95% CI: 0.31–0.59), P<0.0001
Figure adapted from Monk BJ, et al. 2020
HR: 0.68 which means
reduction in risk of progression or death with ZEJULA vs placebo2,3,5
(95% CI: 0.49–0.94)
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
*Censored subjects are indicated by circles
Figure adapted from Monk BJ, et al. 2020
HR: 0.50 which means
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.
*Censored subjects are indicated by circles
Figure adapted from Monk BJ, et al. 2020
HR: 0.40 which means
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.
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.
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 4411 or UKSafety@gsk.com
© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.
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