Efficacy by Cohort

For women whose recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer responded with a CR or PR to platinum-based chemotherapy

ZEJULA Demonstrated a Significant Reduction in Risk of Disease Progression or Death in Both gBRCAmut and Non-gBRCAmut Cohorts1

Median PFS with ZEJULA was nearly 4x longer than placebo in the gBRCAmut cohort1

Median PFS with ZEJULA was more than 2x longer than placebo in the non-gBRCAmut cohort1

In the gBRCAmut cohort, it is estimated that long-term PFS of 24 months would be achieved in 42% of women receiving ZEJULA compared with 16% receiving placebo2

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 placebo2

  • BRCA wild-type tumors are historically difficult to treat and are associated with poorer outcomes4
  • In the non-gBRCAmut cohort, approximately 71% of women had tumors that were known to be BRCA wild type3

For women whose recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer responded with a CR or PR to platinum-based chemotherapy1

ZEJULA Showed Meaningful Clinical Benefit in a Phase 3 Study in the BRCA Wild-Type Population3

A subgroup analysis showed PFS improvement across subpopulations evaluated3

  • 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 subgroup2,3
  • BRCA wild-type tumors are historically difficult to treat and are associated with poorer outcomes4

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 placebo2

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 placebo2

References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Data on file. TESARO, Inc. 3. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. 4. Hollis RL, Churchman M, Gourley C. Distinct implications of different BRCA mutations: efficacy of cytotoxic chemotherapy, PARP inhibition and clinical outcome in ovarian cancer. Onco Targets Ther. 2017;10:2539-2551. 

Efficacy summary

EFFICACY SUMMARY

See the clinical efficacy summary for ZEJULA

See Summary

Study design

STUDY DESIGN

See the clinical rigor behind the pivotal trial design for ZEJULA

View Trial Info

Safety data

SAFETY DATA

Learn about the safety and tolerability of ZEJULA

See Safety

Pivotal trial

PIVOTAL TRIAL

See the pivotal phase 3 trial publication

Access Publication