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First-Line Maintenance Treatment of Platinum-Responsive Advanced Ovarian Cancer

PRIMA

Study Design

The PRIMA Trial Assessed ZEJULA as 1L Maintenance in Patients With Advanced Ovarian Cancer in Response to Platinum-Based Chemotherapy, Regardless of Biomarker Status1,2

PRIMA was a randomized, double-blind, placebo-controlled phase 3 trial examining the efficacy and safety of ZEJULA in patients with newly diagnosed advanced ovarian cancer.1,2

PRIMA was a randomized, double-blind, placebo-controlled phase 3 trial examining the efficacy and safety of ZEJULA in patients with newly diagnosed advanced ovarian cancer.1,2

In PRIMA, HRd status was determined using the FDA-approved Myriad™ myChoice CDx as either tBRCA+ and/or GIS+ (GIS ≥42).1,3

*Patients in PRIMA received an individualized starting dose of either 200 mg or 300 mg based on their baseline body weight or platelet count (n=255), or a fixed starting dose of 300 mg daily (n=473) regardless of body weight or platelet count.1,3

PRIMA included patients with poor prognoses1,2,4-8

Visual showing 85% residual disease following primary debulking surgery, 35% of patients stage IV, 31% partial response to 1L platinum-based chemotherapy

Stage III and IV disease with visible residual tumor (>0 cm) after primary debulking surgery.8

Primary Efficacy: Overall Population

ZEJULA Significantly Improved PFS in Newly Diagnosed Patients who Responded to Platinum-Based Chemotherapy, Regardless of Biomarker Status1,2

PFS in the OVERALL POPULATION (N=733)
Graph showing PFS in overall population with 38% reduction in risk of disease progression or death.

  †  Censored subjects are indicated by circles.

Overall population for PRIMA included: HRd/BRCA+, HRd/BRCA-, HRp/BRCA-

The overall population included1*:

Overall population for PRIMA included: HRd/BRCA+, HRd/BRCA-, HRp/BRCA-

  

Primary Efficacy: HRd Population

In the HRd Population, ZEJULA Doubled Median PFS Compared With Placebo1,2

PFS in the HRd POPULATION (n=373, 51% of overall study population)1,2
Graph showing 57% reduction in risk of disease progression or death.
Graph showing 57% reduction in risk of disease progression or death.

  §  Censored subjects are indicated by circles.

Up to 50% of ovarian tumors are homologous recombination deficient, which includes BRCA+ tumors9

Up to 50% of ovarian tumors are homologous recombination deficient, which includes BRCA+ tumors9

Exploratory Analysis: Patient Subgroups

In Patient Subgroups With Poor Prognoses, a Reduction in the Risk of Disease Progression or Death Was Observed With ZEJULA Compared With Placebo1,2

These prespecified subgroup analyses were exploratory in nature and were not powered to detect statistically significant treatment effect; therefore, results should be interpreted with caution.1,2

Chart showing patient subgroups, hazard ratio for disease progression or death, and median PFS.

At the time of the PFS analysis, limited overall survival data were available with 11% deaths in the overall population.1

Exploratory Analysis: Quality of Life

In an Exploratory Analysis of Patient-Reported Outcomes, Health-Related Quality of Life Was Maintained Throughout the Duration of Treatment2,3

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 nondrug factors.2

Graph showing FOSI Adjusted Health Utility Index Score

FOSI is a validated 8-item measure of symptom response to treatment, including lack of energy, vomiting, pain, nausea, stomach swelling, worsening condition, quality of life as assessed by the patient, and cramps in the stomach area.3



Values displayed in the chart above are adjusted means; a higher score indicates fewer symptoms.3

1L, first-line; BRCA, breast cancer susceptibility gene; BRCA+, BRCA-mutated; BRCA−, not BRCA-mutated; CI, confidence interval; CR, complete response; FOSI, Functional Assessment of Cancer Therapy-Ovarian Symptoms Index; GIS, genomic instability score; HR, hazard ratio; HRd, homologous recombination deficient; HRp, homologous recombination proficient; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; PR, partial response; SE, standard error; tBRCA+, tumor BRCA-mutated.

ZEJULA (niraparib) 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

References: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2020. 2. González‑Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):2391-2402. 3. González‑Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer [supplementary appendix]. N Engl J Med. 2019;381(25):2391-2402. 4. Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer Statistics Review. 1975-2016. Bethesda, MD: National Cancer Institute. https://seer.cancer.gov/csr/1975_2016/, based on November 2019 SEER data submission, posted to the SEER website, April 2020. Accessed August 7, 2020. 5. Horowitz NS, Miller A, Rungruang B, et al. Does aggressive surgery improve outcomes? Interaction between preoperative disease burden and complex surgery in patients with advanced-stage ovarian cancer: an analysis of GOG 182. J Clin Oncol. 2015;33(8):937-943. 6. Chang S-J, Hodeib M, Chang J, Bristow RE. Survival impact of complete cytoreduction to no gross residual disease for advanced-stage ovarian cancer: a meta-analysis. Gynecol Oncol. 2013;130(3):493-498. 7. Davis A, Tinker AV, Friedlander M. “Platinum resistant” ovarian cancer: what is it, who to treat and how to measure benefit? Gynecol Oncol. 2014;133(3):624-631. 8. Data on file. GlaxoSmithKline. 9. Integrated genomic analyses of ovarian carcinoma. Nature. 2011;474(7353):609-615.