How Would Your Patients With BRCA Wild-type Recurrent Ovarian Cancer Benefit From ZEJULA?1

  • Median PFS, gBRCAmut cohort: 21 months with ZEJULA vs 5.5 months with placebo (HR=0.26; 95% CI, 0.17-0.41, P<0.0001)1
  • Median PFS, non-gBRCAmut cohort: 9.3 months with ZEJULA vs 3.9 months with placebo (HR=0.45; 95% CI, 0.34-0.61, P<0.0001)1

 

ZEJULA demonstrated meaningful clinical benefit in a phase 3 study in the BRCA wild-type population2-4

  • ZEJULA demonstrated a clinically meaningful PFS benefit in women with difficult-to-treat BRCAwt tumors2-4
  • This subgroup analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup4

In the BRCA wild-type HRDpos subpopulation, it is estimated that long-term PFS of 24 months would be achieved in 22% of women receiving ZEJULA, compared with 6% receiving placebo.4

Study Design: NOVA, a phase 3, double-blind, placebo-controlled trial, evaluated the safety and efficacy of ZEJULA in women (N=553) with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following CR or PR to second-line or later platinum-based chemotherapy. Patients were randomized to receive ZEJULA or placebo once daily. The primary end point was PFS as assessed by an independent review. NOVA separately evaluated PFS in both the gBRCAmut and non-gBRCAmut cohorts. PFS was measured from time of randomization to time of disease progression or death.2

ZEJULA is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9

In the BRCA wild-type HRDneg subpopulation, it is estimated that long-term PFS of 24 months would be achieved in 19% of women receiving ZEJULA compared with 7% receiving placebo.4-5

Study Design: NOVA, a phase 3, double-blind, placebo-controlled trial, evaluated the safety and efficacy of ZEJULA in women (N=553) with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following CR or PR to second-line or later platinum-based chemotherapy. Patients were randomized to receive ZEJULA or placebo once daily. The primary end point was PFS as assessed by an independent review. NOVA separately evaluated PFS in both the gBRCAmut and non-gBRCAmut cohorts. PFS was measured from time of randomization to time of disease progression or death.2

ZEJULA is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9

Is There More That Can Be Done for Difficult-to-Treat Patients?

NOVA Is the Only Phase 3 Trial of a PARP Inhibitor to Isolate and Evaluate Efficacy in the gBRCAmut Population and the Difficult-to-treat Non-gBRCAmut Population2,3,7,8

  • Olaparib has not been evaluated in the non-gBRCAmut population in a phase 3 trial7,8
  • The evidence for use of olaparib in the BRCAwt population is based on a phase 2 exploratory retrospective analysis8
  • Cross-trial comparisons of efficacy and safety are not appropriate given differences in trial designs

NOVA Is the Only Phase 3 Trial of a PARP Inhibitor to Isolate and Evaluate Efficacy in the gBRCAmut Population and the Difficult-to-treat Non-gBRCAmut Population2,3,7,8

 

Learn More About the Clinically Rigorous Evaluation of ZEJULA

All PARP Inhibitors Are Not the Same1,9,10

  • Each PARP inhibitor needs to be assessed based on its own data; data cannot be extrapolated from one PARP inhibitor to another
  • When choosing a PARP inhibitor, it is important to understand pharmacologic properties and data in the specific population under consideration

 

ZEJULA has high bioavailability, a long half-life, and extensive tissue distribution1

See the Pre-clinical Data That Informed the NOVA Trial

 

Learn More

ZEJULA Demonstrated Efficacy Following Prior Treatment With Bevacizumab2,3

Of the 26% of patients treated with ZEJULA who received prior bevacizumab in conjunction with the penultimate or last platinum regimen, 16% received ZEJULA as switch maintenance.1

Select Adverse Reactions Were Dose Dependent and Managed With Dose Modifications in the NOVA Study

Find the Right Dose for Your Patients Based on the “Weights and Plates” Exploratory Analysis12

TOGETHER with TESAROTM Provides Support For Your Patients

BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutated; BRCAwt, BRCA wild type; CR, complete response; F, bioavailability; HR, hazard ratio; HRD, homologous recombination deficiency; HRDneg, HRD negative; HRDpos, HRD positive; mo, months; NA, not available; PARP, poly(ADP-ribose) polymerase; PFS, progression-free survival; T1/2, terminal elimination half-life; Vd/F, apparent volume of distribution.