See study design for new use >>

Study Designs

NOVA Is the Only Phase 3 Trial of a PARP Inhibitor to Isolate and Evaluate Efficacy in the gBRCAmut and in the Difficult-to-Treat Non-gBRCAmut Cohorts1-3

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

*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 patients. Approximately 13% of women in the non-gBRCAmut cohort had tumors that were known to be sBRCAmut.1

The non-gBRCAmut cohort included patients whose tumors were sBRCAmut or BRCAwt. Approximately 13% of women in the non-gBRCAmut cohort had tumors that were known to be sBRCAmut.1,5

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). Patients continued to receive ZEJULA or placebo until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up, whichever came first.1,5

§CT or MRI was performed at baseline and every 8 weeks through cycle 14, then every 12 weeks until treatment discontinuation. PFS was determined by central independent assessment per RECIST v1.1 or by more conservative measures of clinical signs and symptoms and increasing CA-125.1,5

||Additional diagnostic tests included histology/cytology, ultrasound, endoscopy, and PET.1,5, 6

ZEJULA Was Evaluated With the Clinical Rigor of a Phase 3 Trial (NOVA) That Independently Tested Treatment Benefit in gBRCAmut and Non-gBRCAmut Cohorts1,4

In the non-gBRCAmut cohort, additional exploratory analyses were conducted in HRDpos and HRDneg subpopulations1

In the NOVA trial, patient demographics were well-balanced across treatment arms and representative of women seen in clinical practice1,4,5

  • 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 maintenance1,5,6

QUADRA evaluated ZEJULA as treatment in 4th-line+ patients, including those with BRCA– or platinum-resistant disease5

QUADRA: a single-arm, Phase 2 trial of patients (N=463) with advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy.5

BRCA, breast cancer susceptibility gene; BRCAwt; BRCA wild type; CA-125, cancer antigen 125; CR, complete response; CT, computed tomography; gBRCAmut, germline BRCA mutated; HRDneg, homologous recombination deficiency negative; HRDpos, HRD positive; MRI, magnetic resonance imaging; non-gBRCAmut, not germline BRCA mutated; PARP, poly(ADP-ribose) polymerase; PET, positron emission tomography; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumors; sBRCAmut, somatic BRCA mutated.

References: 1. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix. 2. Coleman RL, Oza AM, Lorusso D, et al; ARIEL3 investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6. 3. Pujade-Lauraine E et al; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. 4. Mahner S, Mirza MR, Moore K, et al. ENGOT-OV16/NOVA: results for secondary efficacy endpoints of niraparib treatment in ovarian cancer. Slide deck presented at: Annual Meeting on Women’s Cancer; March 12-15, 2017; National Harbor, MD. 5. ZEJULA (niraparib) [package insert]. Waltham, MA: TESARO, Inc.; October 2019. 6. Data on file. TESARO, Inc. 7. Moore KN et al. Lancet Oncol. 2019;20(5):636-648. 8. Moore KN et al. QUADRA: a phase 2, open-label, single-arm study to evaluate niraparib in patients with relapsed ovarian cancer in the 4th or later line of therapy: results from the BRCAmut subset. Poster presented at: European Society for Medical Oncology Annual Meeting; October 19-23, 2018; Munich, Germany.

Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing
Safety data

SAFETY DATA

Learn about the safety and tolerability of ZEJULA

See Safety
Back to Top