- 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
¶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
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
Patient characteristics in the QUADRA trial (N=463) are representative of a real-world, late-line population7
- 27% of patients were 6th line or later
- 68% of patients were platinum resistant or refractory
The FDA indication is for HRD+ patients (in QUADRA, n=98) with either5,8:
- BRCA+ tumors regardless of platinum status
- BRCA– tumors with genomic instability (GIS+) and had progressed more than 6 months after the last platinum-based chemotherapy
*19% of patients were 6th line or later.
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.