Study Design

ZEJULA: Clinically Rigorous Evaluation in the NOVA Phase 3 Trial1,2

The treatment benefit of ZEJULA was independently tested in gBRCAmut and non-gBRCAmut populations*1,2

The NOVA Trial included 553 women with recurrent ovarian, fallopian tube, or primary peritoneal cancer following complete or partial response (CR or PR) to second-line or later platinum-based chemotherapy1

* The non-gBRCAmut cohort included patients whose tumors were somatic BRCA mutated or BRCA wild type. Approximately 13% of women in the non-BRCA cohort had tumors that were known to be sBRCAmut.1

BRCA, breast cancer susceptibility gene; gBRCAmut, germline BRCA mutated; non-gBRCAmut, not germline BRCA mutated; sBRCAmut, somatic BRCA mutated.

The NOVA Patient Population Independently Tested Women With or Without Germline BRCAmut Tumors
The NOVA patient population independently tested women with or without Germline BRCAmut tumors

PFS was measured from time of randomization to time of disease progression or death1,2

  • PFS was determined to occur at the earlier of either radiographic progression or clinical signs and symptoms and increasing CA-1253
  • The primary endpoint was progression-free survival (PFS) as assessed by blinded, independent, central review of both clinical AND radiologic progression per RECIST v1.1, with a frequent scan interval1,2
    • Radiologic assessment was performed at baseline and every 8 weeks through cycle 14, then every 12 weeks until treatment discontinuation2
    • Clinical assessment also included conservative measures of signs and symptoms, not limited to increasing CA-125 levels1
  • Secondary endpoints included patient-reported outcomes, time to second subsequent therapy, and overall survival2

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 (CR and PR).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 by central independent assessment per RECIST v1.1, along with more conservative measures of clinical signs and symptoms and increasing CA-125 every 12 weeks until treatment discontinuation.2

BRCA, breast cancer susceptibility gene; CA-125, cancer antigen 125; CR, complete response; CT, computed tomography; gBRCAmut, germline BRCA mutated; MRI, magnetic resonance imaging; non-gBRCAmut, not germline BRCA mutated; PFS, progression-free survival; sBRCAmut, somatic BRCA mutated.

The Non-gBRCAmut Cohort Included HRDneg, BRCA Wild-Type and sBRCAmut Patients2

In the non-gBRCAmut cohort, women whose tumors had no BRCA mutation and women whose tumors were homologous recombination deficiency negative (HRDneg) comprised the majority of patients2

  • Approximately 13% of women in the non-gBRCAmut cohort had tumors that were known to be sBRCAmut.2

References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. 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. 3. Data on file. TESARO, Inc. 

 

Patient characteristics

PATIENT CHARACTERISTICS

Is ZEJULA right for my patient? See patient characteristics

View Characteristics

Efficacy data

EFFICACY DATA

See PFS in HRDpos and HRDneg patient subgroups

View Efficacy

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