Efficacy | Zejula® (niraparib)

ZEJULA Improved PFS in Both gBRCAmut and non-gBRCAmut Cohorts1

ZEJULA was evaluated in a double-blind, placebo-controlled phase 3 trial1

BRCA, breast cancer susceptibility gene; CA-125, cancer antigen 125; CT, computed tomography; gBRCAmut, germline BRCA mutated; MRI, magnetic resonance imaging; non-gBRCAmut, not germline BRCA mutated; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors.

a The non-gBRCAmut cohort included patients whose tumors were somatic BRCA mutated or BRCA wild type. Approximately 13% of women in the non-gBRCAmut cohort had tumors that were known to be sBRCAmut.2

b Randomization occurred within 8 weeks of the last dose of platinum-based therapy and was stratified by time to progression after the penultimate platinum therapy (6 to <12 months and ≥12 months), use of bevacizumab in conjunction with the penultimate or last platinum regimen (yes vs no), and best response during the last platinum regimen (complete response and partial response).1 Patients continued to receive ZEJULA or placebo until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up, whichever came first.2

c CT or MRI was performed at baseline and every 8 weeks through cycle 14, then every 12 weeks until treatment discontinuation.2 PFS was determined primarily by central independent assessment per RECIST v1.1. In some cases, clinical signs and symptoms and increasing CA-125 were also applied.1

  • Trial included women with and without a germline BRCA mutation (gBRCAmut and non-gBRCAmut)1
  • 51% of all patients were in complete response to most recent platinum-based regimen1
  • 26% of patients treated with ZEJULA had received prior bevacizumab therapy1

Please see Important Safety Information below and full Prescribing Information.

Results for Progression-Free Survival (PFS), the Primary End Point1

The NOVA trial demonstrated a statistically significant improvement in PFS for patients receiving ZEJULA compared with patients receiving placebo in both the gBRCAmut and the non-gBRCAmut cohorts.

In the gBRCAmut cohort, median PFS was 21.0 months with ZEJULA vs 5.5 months with placebo

  • ZEJULA reduced the risk of disease progression or death by 74% (HR = 0.26; 95% CI, 0.17-0.41), P < 0.00011
  • Long-term PFS of 18 months was achieved in 50% of women with gBRCAmut tumors receiving ZEJULA

PFS in the gBRCAmut cohort

BRCA, breast cancer susceptibility gene; CI, confidence interval; gBRCAmut, germline BRCA mutated; HR, hazard ratio; PFS, progression-free survival.

At the time of PFS analysis, limited overall survival data were available with 17% deaths across the two cohorts.

In the non-gBRCAmut cohort, median PFS was 9.3 months with ZEJULA vs 3.9 months with placebo

  • ZEJULA reduced the risk of disease reduced the risk of disease progression or death by 55% (HR = 0.45; 95% CI, 0.34-0.61), P < 0.0001 1
  • Approximately 13% of women in the non-gBRCAmut cohort had tumors that were known to be sBRCAmut 2

PFS in the non-gBRCAmut cohort1

BRCA, breast cancer susceptibility gene; CI, confidence interval; HR, hazard ratio; non-gBRCAmut, not germline BRCA mutated; PFS, progression-free survival; sBRCAmut, somatic BRCA mutated.

See safety and tolerability data