Observation Is No Longer the Optimal Treatment Approach for Recurrent Ovarian Cancer Following a PR or CR to Platinum-based Chemotherapy1

After responding to chemotherapy, many women are closely monitored for recurrence without receiving active treatment. Maintenance therapy is emerging as the new standard to help maintain quality of life and extend progression-free survival (PFS) between recurrences.1

Maintenance with a PARP inhibitor like ZEJULA is evolving to be the new standard of care to help extend progression-free survival (PFS) between recurrences while maintaining quality of life1,2

Is Observation the Only Option After a Response to Chemotherapy?

ZEJULA Demonstrated Significant Reduction in Risk of Disease Progression or Death in Both the gBRCAmut and Non-gBRCAmut Cohorts2-4

  • In the gBRCAmut cohort, the median PFS with ZEJULA was nearly 4x longer than placebo
  • In the non-gBRCAmut cohort, the median PFS with ZEJULA was more than 2x longer than placebo

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.3

The median PFS with ZEJULA was more than 2× longer than placebo2-4 

In the non-gBRCAmut cohort, it is estimated that long-term PFS of 24 months would be achieved in 27% of women receiving ZEJULA compared with 12% receiving placebo.3,4

ZEJULA Showed Meaningful Clinical Benefit in a Phase 3 Study in the BRCA Wild-type Population2,5,6

A subgroup analysis showed PFS improvement across subpopulations evaluated2,5,6

  • ZEJULA demonstrated a clinically meaningful PFS benefit in women with difficult-to-treat BRCAwt tumors2,5,6
  • 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 subgroup6

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.2

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.2,4

ZEJULA Provided More Time Without Disease Progression, Independent of Baseline Patient Characteristics2,3

In an exploratory analysis, ZEJULA provided similar magnitude of benefit within key demographic and prognostic subgroups.

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.6

In an Exploratory Analysis, Patients Taking ZEJULA Reported Having a Quality of Life (QoL) Similar to Baseline Throughout Treatment2,5

This analysis is exploratory in nature and does not control for type 1 error; elements more distal to disease and treatment-related symptoms may be influenced by multiple non-drug factors.6

A Broad Indication for Maintenance Treatment in Recurrent Ovarian Cancer3

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.3

 

Appropriate patients for ZEJULA

Appropriate candidates for ZEJULA have received at least 2 platinum-containing regimens of chemotherapy and are in CR or PR to their most recent platinum-based regimen. No biomarker test is required to initiate treatment with ZEJULA.2,3,6

ZEJULA Demonstrated Significant PFS Improvement in Both the gBRCAmut and non-gBRCAmut Cohorts, Regardless of PR or CR to Prior Chemotherapy3

  • For patients who only achieved a PR to their last platinum-based therapy, ZEJULA delayed disease progression just as effectively as it did for patients with a CR2,8
  • In a pooled analysis of gBRCAmut and non-gBRCAmut cohorts in the NOVA study, ZEJULA provided a PFS advantage and, in a second exploratory analysis, was determined to not compromise the benefits of subsequent therapy4

ZEJULA Did Not Compromise the Benefit of Subsequent Therapy4

To determine the impact of ZEJULA on subsequent therapy for patients who progressed on subsequent therapy, patients’ PFS1 was subtracted from patients’ PFS2. ZEJULA had no decremental effect on the benefit of subsequent therapy, suggesting that resistance to post-progression therapy did not occur.4

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

  • PFS1 is the same as PFS, the primary endpoint of ENGOT-OV16/NOVA2,4
  • PFS2 was defined as the time from treatment randomization to the date of assessment of progression on the next anticancer therapy following study treatment or death by any cause, whichever occurred first4
  • PFS1 subtracted from PFS2 determined the effect of ZEJULA on subsequent therapy for patients who progressed4
  • PFS1 subtracted from PFS2 was similar between the ZEJULA and placebo arms (HR=1.02; 95% CI, 0.765-1.349) across all cohorts4

ZEJULA Improved Estimated Probability of Long-term PFS Across All Cohorts and Subpopulations4

  • An analysis of the NOVA data was conducted to calculate the likelihood of disease progression at various time points after treatment initiation4
  • The specific data points do not represent the primary efficacy analysis or the overall efficacy of ZEJULA

Select Adverse Reactions Were Dose Dependent and Managed With Dose Modifications in the NOVA Study3

Find the Right Dose for Your Patients Based on the “Weights and Plates” Exploratory Analysis9

TOGETHER with TESAROTM Provides Support for Your Patients

BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutated; BRCAwt, BRCA wild type; CR, complete response; HR, hazard ratio; HRD, homologous recombination deficiency; HRDneg, HRD negative; HRDpos, HRD positive; mo, months; PARP, poly(ADP-ribose) polymerase; PFS, progression-free survival; PR, partial response.