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Efficacy

PRIMA Study Design - A Phase 3 Trial in Advanced Ovarian Cancer^1,2

PRIMA was a randomized, double-blind, placebo-controlled phase 3 trial examining the efficacy and safety of ZEJULA as 1L maintenance 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 tBRCAm and/or GIS+ (GIS ≥42).^1,3

^aPatients were stratified based on neoadjuvant chemotherapy administered (yes or no), best response to 1L platinum therapy (CR or PR) and homologous recombination (HR) status (deficient [HR-deficient], proficient [HR-proficient], or not determined).^1,2

^bPatients in PRIMA received a starting dose of either 200 mg or 300 mg based on their baseline body weight or platelet count (n=169), or a fixed starting dose of 300 mg daily (n=315) regardless of body weight or platelet count.^1-3

PRIMA enrolled a broad range of patients, including patients with poor prognoses who were at higher risk of progression^1,2,4-7:

Of patients in the overall population (N=733):

35%

had stage IV disease^1,2

67%

had received
neoadjuvant chemotherapy^1,2

84%

had residual disease after
primary debulking surgery^4,c

Placebo: 8.2 Months^1,2

MEDIAN PFS IN OVERALL POPULATION

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

^cStage III and IV disease with visible residual tumor (>0 cm) after primary debulking surgery.⁴

The PRIMA population may be reflective of your clinical practice⁸

ZEJULA is the only once-daily oral PARP inhibitor monotherapy available for HRd patients.^1,9,10

PFS in HRd Population

More than doubled median PFS vs placebo in HRd patients^1,2

PFS in the HRd population (n=373)^1,2,d

^eCensored subjects are indicated by circles.

^dAt the time of primary analysis.

Consistent efficacy observed across exploratory HRd subgroups^2,3,11,f

BRCAwt (n=150)

HR, 0.50
(95% CI, 0.31-0.83)

50% reduction in risk of progression or death

Median PFS of 19.6 months for ZEJULA vs 8.2 months with placebo

BRCAm (n=223)

HR, 0.40
(95% CI, 0.27-0.62)

60% reduction in risk of progression or death

Median PFS of 22.1 months for ZEJULA vs 10.9 months with placebo

^fExploratory subgroup analysis, not powered to detect a statistically significant treatment effect. Interpret results with caution.

PFS in Overall Population

ZEJULA may mean more time living progression-free^1,2

Significantly longer median PFS vs placebo^1,2,g

PFS in the overall population (N=733)

PFS in the overall population line graph

^hCensored subjects are indicated by circles.

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

PFS benefit was observed across exploratory patient subgroups vs placebo^2,f

ⁱIf test results were inconclusive or the test was not done, tumors were considered HRnd.²

^fExploratory subgroup analysis, not powered to detect a statistically significant treatment effect. Interpret results with caution.

PRIMA Long-term PFS

HRd Long-term PFS

More than doubled 4-year PFS rates observed with ZEJULA in HRd patients vs placebo¹²

Exploratory ad hoc analysis^j

3.5-year median follow-up of investigator-assessed PFS in the HRd population (n=373)^12,j

3.5-year median follow-up of investigator-assessed PFS in the HRd population line graph

^kCensored subjects are indicated by circles.

^jInterpret results with caution.

Not powered to detect a statistically significant treatment effect
4-year PFS rates estimated from Kaplan-Meier curve, with median follow-up time of 3.5 years¹²

The probability of patients in the HRd population to be alive and progression-free at 4 years was 38% in the ZEJULA arm vs 17% in the placebo arm¹²
With 3.5-year median follow-up, overall survival data remain immature at 41.2% for the overall population¹²

ZEJULA was associated with long-term PFS benefits for patients with HRd ovarian cancer¹²

Overall Population Long-term PFS

Continued confidence with ZEJULA: Durable PFS benefit observed consistent with primary analysis^1,2,12

Exploratory ad hoc analysis^l

3.5-year median follow-up of investigator-assessed PFS in overall population (N=733)^12,l

3.5-year median follow-up of investigator-assessed PFS in the overall population line graph

^mCensored subjects are indicated by circles.

^lInterpret results with caution.

Not powered to detect a statistically significant treatment effect
4-year PFS rates estimated from Kaplan-Meier curve, with median follow-up time of 3.5 years¹²

The probability of patients in the overall population to be alive and progression-free at 4 years was 24% in the ZEJULA arm vs 14% in the placebo arm¹²
With 3.5-year median follow-up, overall survival data remain immature at 41.2% for the overall population¹²

Reduction in risk of progression or death remained consistent with the primary analysis^1,2,12

With ZEJULA, durable outcomes were observed in PRIMA long-term data⁴

View ZEJULA Safety Data

1L = first-line; BRCA = breast cancer susceptibility gene; BRCAm = BRCA-mutated; BRCAwt = BRCA wild type; CI = confidence interval; CR = complete response; FIGO = International Federation of Gynecology and Obstetrics; GIS = genomic instability score; HR = hazard ratio; HRd = homologous recombination deficient; HRnd = homologous recombination status not determined; HRp = homologous recombination proficient; mPFS = median PFS; PARP = poly (ADP-ribose) polymerase; PFS = progression-free survival; PR = partial response; tBRCAm = tumor BRCA-mutated.

References

ZEJULA (niraparib) Tablets. Prescribing Information. GSK; 2023.
González-Martín A, Pothuri B, Vergote I, et al. N Engl J Med. 2019;381(25):2391-2402. doi:10.1056/NEJMoa1910962
González-Martín A, Pothuri B, Vergote I, et al. [supplementary appendix]. N Engl J Med. 2019;381(25):1-42. doi:10.1056/NEJMoa1910962
Data on File, GSK.
Horowitz NS, Miller A, Rungruang B, et al. J Clin Oncol. 2015;33(8):937-943. doi:10.1200/JCO.2014.56.3106
Chang S-J, Hodeib M, Chang J, Bristow RE. Gynecol Oncol. 2013;130(3):493-498. doi:10.1016/j.ygyno.2013.05.040
Davis A, Tinker AV, Friedlander M. Gynecol Oncol. 2014;133(3):624-631. doi:10.1016/j.ygyno.2014.02.038
Rodrigues M, Joly F, Ray-Coquard I, et al. Poster presented at: European Society for Medical Oncology Congress; September 16-21, 2021; virtual.
Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP; 2023.
Rubraca (rucaparib). Prescribing Information. Clovis Oncology, Inc; 2023.
Monk BJ, Han S, Pothuri B, et al. Presented at: Society of Gynecologic Oncology Annual Meeting on Women's Cancer Webinar Series; March 28-31, 2020.
González-Martín A, Pothuri B, Vergote I, et al. Eur J Cancer. 2023;189:112908. doi:10.1016/j.ejca.2023.04.024

Indication & Important Safety Info

Indication

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

ZEJULA (niraparib) capsules 100 mg and tablets 100 mg/200 mg/300 mg are indicated:

for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy

Important Safety Information

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Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with a fatal outcome, have been reported in patients who received ZEJULA. In PRIMA, MDS/AML occurred in 6 out of 484 (1.2%) patients treated with ZEJULA, and in 3 out of 244 (1.2%) patients treated with placebo. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy-related AML varied from 3.7 months to 2.5 years. All patients who developed secondary MDS/cancer therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations.

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose if necessary.

Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Monitor all patients for signs and symptoms of PRES, which include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension. Diagnosis requires confirmation by brain imaging. If suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown.

Embryo-fetal toxicity and lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women not to breastfeed during treatment with ZEJULA and for 1 month after receiving the last dose.

Allergic reactions to FD&C Yellow No. 5 (tartrazine): ZEJULA capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

First-line Maintenance Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (64%), nausea (57%), fatigue (51%), neutropenia (42%), constipation (40%), musculoskeletal pain (39%), leukopenia (28%), headache (26%), insomnia (25%), vomiting (22%), dyspnea (22%), decreased appetite (19%), dizziness (19%), cough (18%), hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%).

Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (87%), decreased platelets (74%), decreased leukocytes (71%), increased glucose (66%), decreased neutrophils (66%), decreased lymphocytes (51%), increased alkaline phosphatase (46%), increased creatinine (40%), decreased magnesium (36%), increased AST (35%), and increased ALT (29%).

Please see accompanying Prescribing Information for ZEJULA capsules and tablets.

Efficacy

PRIMA Study Design - A Phase 3 Trial in Advanced Ovarian Cancer1,2

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

PRIMA enrolled a broad range of patients, including patients with poor prognoses who were at higher risk of progression1,2,4-7:

Of patients in the overall population (N=733):

Placebo: 8.2 Months1,2

ZEJULA is the only once-daily oral PARP inhibitor monotherapy available for HRd patients.1,9,10

PFS in HRd Population

More than doubled median PFS vs placebo in HRd patients1,2

PFS in the HRd population (n=373)1,2,d

Consistent efficacy observed across exploratory HRd subgroups2,3,11,f

BRCAwt (n=150)

50% reduction in risk of progression or death

BRCAm (n=223)

60% reduction in risk of progression or death

PFS in Overall Population

ZEJULA may mean more time living progression-free1,2

PFS in the overall population (N=733)

PFS benefit was observed across exploratory patient subgroups vs placebo2,f

PRIMA Long-term PFS

HRd Long-term PFS

Exploratory ad hoc analysisj

ZEJULA was associated with long-term PFS benefits for patients with HRd ovarian cancer12

Overall Population Long-term PFS

Exploratory ad hoc analysisl

Reduction in risk of progression or death remained consistent with the primary analysis1,2,12

With ZEJULA, durable outcomes were observed in PRIMA long-term data4

References

PRIMA Study Design - A Phase 3 Trial in Advanced Ovarian Cancer^1,2

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

PRIMA enrolled a broad range of patients, including patients with poor prognoses who were at higher risk of progression^1,2,4-7:

Placebo: 8.2 Months^1,2

ZEJULA is the only once-daily oral PARP inhibitor monotherapy available for HRd patients.^1,9,10

More than doubled median PFS vs placebo in HRd patients^1,2

PFS in the HRd population (n=373)^1,2,d

Consistent efficacy observed across exploratory HRd subgroups^2,3,11,f

ZEJULA may mean more time living progression-free^1,2

PFS benefit was observed across exploratory patient subgroups vs placebo^2,f

Exploratory ad hoc analysis^j

ZEJULA was associated with long-term PFS benefits for patients with HRd ovarian cancer¹²

Exploratory ad hoc analysis^l

Reduction in risk of progression or death remained consistent with the primary analysis^1,2,12

With ZEJULA, durable outcomes were observed in PRIMA long-term data⁴