Efficacy Summary
Understanding the Clinical Benefits of ZEJULA
ZEJULA demonstrated significant improvement in progression-free survival, regardless of BRCA status1
Women with recurrent ovarian, fallopian tube, or primary peritoneal cancer benefited from ZEJULA, regardless of BRCA mutation status1
*Efficacy analysis was based on a blinded central independent radiologic and clinical oncology review committee.
† Based on a stratified Cox proportional hazards model.
‡ Based on a stratified log-rank test.
BRCA, breast cancer susceptibility gene; CI, confidence interval; gBRCAmut, germline BRCA mutated; HR, hazard ration; NR, not reached; non-gBRCAmut, not germline BRCA mutated; PFS, progression-free survival.
The National Comprehensive Cancer Network® (NCCN) guidelines recommend niraparib (ZEJULA) for maintenance therapy of patients with platinum-sensitive, recurrent ovarian cancer following partial or complete response to platinum-based chemotherapy.2
ZEJULA Provided More Time Without Disease Progression, Across Patient Subgroups, Regardless of BRCA Status1,3
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.4
Similar magnitude of benefit within key demographic and prognostic subgroups3,4
BRCA, breast cancer susceptibility gene; CI, confidence interval; CR, complete response; gBRCAmut, germline BRCA mutated; HR, hazard ratio; HRD, homologous recombination deficiency; n/a, not applicable; non-gBRCAmut, not germline BRCA mutated; PR, partial response.
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer v4.2017. http://www.nccn.org/professionals/physician/gls/pdf/ovarian.pdf. Accessed December 10, 2017. 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. Data on file. TESARO, Inc.
