Tolerability and Quality of Life

ZEJULA Showed Long-term Tolerability in the NOVA Trial After Dose Modification, Including Patients Receiving Treatment for
>3 Years1

A long-term safety analysis of the NOVA study assessed the incidence of TEAEs in patients receiving ZEJULA for up to 4 years. Of the initial 367 patients in the ZEJULA treatment group and 179 in the placebo treatment group, 18.8% and 5.6% of patients were included in the 2- to 4-year evaluation period, respectively.

Quality of life was similar between patients under observation (placebo) and those receiving active treatment1

Based on the FOSI test, patients who received ZEJULA as maintenance treatment retained a quality of life comparable to placebo during their treatment1

  • Values displayed in the chart below are adjusted means; a higher score indicates fewer symptoms
  • This analysis is exploratory in nature and does not control for type 1 error; elements more distal to disease and treatment-related symptoms may be influenced by multiple non-drug factors2

More data: See FOSI Scale

  • FOSI completion rates were high and similar in the 2 treatment groups: 75% to 97% in the ZEJULA group and 80% to 97% in the placebo group2
  • Patients were assessed at baseline, every 8 weeks for the first year, every 12 weeks thereafter during treatment, and then 6-10 weeks after treatment discontinuation2

FOSI, Functional Assessment of Cancer Therapy-Ovarian Symptoms Index; gBRCAmut, germline breast cancer susceptibility gene mutated; non-gBRCAmut, not germline BRCA mutated; SE, standard error; TEAEs, treatment-emergent adverse events.

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. Data on file. TESARO, Inc. 
 

Study design

STUDY DESIGN

See the pivotal trial design

View Trial Info
Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing
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