FIRST-LINE MAINTENANCE THERAPY OF ADVANCED OVARIAN CANCER WITH ZEJULA (niraparib)

Proven Efficacy in 1L Maintenance
Regardless of Biomarker Status1,2

ZEJULA is the only once-daily oral PARP inhibitor monotherapy
approved for all eligible first-line platinum responders with
advanced ovarian cancer, regardless of biomarker status1-4

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HRd, BRCAm

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HRd, BRCAwt

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HRp, BRCAwt

ZEJULA is the only once-daily oral PARP inhibitor monotherapy approved for all eligible first-line platinum responders with advanced ovarian cancer, regardless of biomarker status1-4

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HRd, BRCAm

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HRd, BRCAwt

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HRp, BRCAwt


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 study design
PRIMA study design

In PRIMA, HRd status was determined using the FDA-approved Myriad™ myChoice CDx as either tBRCA+ and/or GIS+ (GIS ≥42).1,5

Patients were stratified based on neoadjuvant chemotherapy administered (yes or no), best response to first-line platinum therapy (CR or PR), and homologous recombination (HR) status (deficient [HR-deficient], proficient [HR-proficient], or not determined).1

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=258), or a fixed starting dose of 300 mg daily (n=475) regardless of body weight or platelet count.1

PRIMA enrolled a broad range of patients, including patients with poor prognoses1,2,6-10:

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Of patients in the overall population:

85 percent

HAD Residual Disease10‡
AFTER PRIMARY DEBULKING SURGERY

35 percent

HAD Stage IV Disease1

67 percent

HAD RECEIVED
Neoadjuvant Chemotherapy1,2

Placebo: 8.2 Months1
MEDIAN PFS IN OVERALL POPULATION

  • 72% of patients on placebo estimated to have progressed or died within 2 years after diagnosis2

Stage III and IV disease with visible residual tumor (>0 cm) after primary debulking surgery.10


primary efficacy

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.
Graph showing PFS in overall population with 38% reduction in risk of disease progression or death.

The overall population consisted of1||:

overall-population-graphic

Censored subjects are indicated by circles.

Patients with HRnd (n=111) were included in the overall population.2

In the HRd population, ZEJULA doubled median PFS compared with placebo1,2

PFS in the HRd Population (n=373, 51% of overall study population)

Graph showing 57% reduction in risk of disease progression or death.
Graph showing 57% reduction in risk of disease progression or death.

60% of patients in the HRd population were BRCAm2

Censored subjects are indicated by circles.


exploratory efficacy

A reduction in the risk of disease progression or death was observed with ZEJULA compared with placebo across multiple patient subgroups1,2

These prespecified subgroup analyses are exploratory in nature and were not powered to detect a 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.
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

60% reduction in the risk of disease progression or death compared with placebo was observed in a prespecified exploratory analysis of the BRCAm subgroup2,3,10

This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

PFS in the BRCAm Population (n=223)2

Graph showing PFS observed in HRd BRCAwt population with 60% reduction in risk of disease progression or death.
Graph showing PFS observed in HRd BRCAwt population with 60% reduction in risk of disease progression or death.

The efficacy with ZEJULA was observed to be consistent in HRd subgroups, regardless of BRCA status2,5,11

Censored subjects are indicated by circles.2

Figure adapted from Monk BJ, et al. 2020.11

50% reduction in the risk of disease progression or death compared with placebo was observed in a prespecified exploratory analysis of the HRd BRCAwt subgroup2,3,10

This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

PFS in the HRd BRCAwt Population (n=150)2

Graph showing PFS observed in BRCAm population with 50% reduction in risk of disease progression or death.
Graph showing PFS observed in HRd BRCAwt population with 60% reduction in risk of disease progression or death.

The efficacy with ZEJULA was observed to be consistent in HRd subgroups, regardless of BRCA status2,5,11

Censored subjects are indicated by circles.2

Figure adapted from Monk BJ, et al. 2020.11

Among the subgroup of patients with HRp (n=249)2

  • HR, 0.68 (95% CI, 0.49-0.94)

Among the subgroup of patients with HRnd (n=111)2#

  • HR, 0.85 (95% CI, 0.51-1.43)

#If test results were inconclusive or the test was not done, tumors were considered as homologous recombination status not determined (HRnd).5


quality of life

In an exploratory analysis, health-related quality of life was maintained with ZEJULA and comparable to placebo2,5

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.

FOSI in the Overall Population

Graph showing FOSI Adjusted Health Utility Index Score
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.5

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