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A Deeper Dive into ZEJULA Dosing in the PRIMA Trial

Join Dr. Joshua Kesterson as he discusses ZEJULA dosing in the PRIMA trial.

Join Dr. Joshua Kesterson as he discusses ZEJULA dosing in the PRIMA trial.

  • VIDEO TRANSCRIPT | 16:00

    ONSCREEN TEXT THAT APPEARS THROUGHOUT REMAINDER OF THE VIDEO:
    [ZEJULA logo]
    Please see Important Safety Information throughout this presentation. Please see the full Prescribing Information at zejulahcp.com

    ONSCREEN TEXT:
    ZEJULA Dosing in the PRIMA Trial

    ZEJULA is indicated for the 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.

    Program sponsored by GSK. Speaker is contracted for this service. Information presented is consistent with FDA guidelines.

    ZEJULA Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    Hello. My name is Dr. Joshua Kesterson and today we will be discussing ZEJULA Dosing in the PRIMA Trial.

    This presentation will discuss ZEJULA capsules, also known as niraparib, a once-daily oral poly (ADP-ribose) polymerase 1 and 2, more frequently referred to as PARP1 and PARP2, inhibitor indicated for the 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.


    ONSCREEN TEXT:
    Important Safety Information:
    Myelodysplastic syndrome/acute myeloid leukemia

    JOSHUA KESTERSON:
    First, let’s discuss some important safety information for ZEJULA.


    ONSCREEN TEXT:
    Important Safety Information:
    Myelodysplastic syndrome/acute myeloid leukemia

    Myelodysplastic syndrome or acute myeloid leukemia (MDS/AML), including some fatal cases, was reported in 15 patients (0.8%) out of 1,785 patients treated with ZEJULA monotherapy in clinical trials

    • The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from 0.5 months to 4.9 years. These patients had received prior chemotherapy with platinum agents and/or other DNA-damaging agents including radiotherapy
    • Discontinue ZEJULA if MDS/AML is confirmed


    AML, acute myeloid leukemia; MDS, myelodysplastic syndrome.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    NARRATOR:
    Myelodysplastic syndrome or acute myeloid leukemia, which will be referred to hereafter as MDS or AML, including cases with fatal outcome, has been reported in patients who received ZEJULA monotherapy in clinical trials.

    In one thousand seven hundred eighty-five patients treated with ZEJULA in clinical trials, MDS or AML occurred in 15 patients, or 0.8%.

    The duration of therapy with ZEJULA in patients who developed secondary MDS or cancer therapy–related AML varied from 0.5 months to 4.9 years. These 15 patients had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

    Discontinue ZEJULA if MDS or AML is confirmed.


    ONSCREEN TEXT:
    Important Safety Information:
    Hematologic adverse reactions

    Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA.

    • In PRIMA, the overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients

    • In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count, 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

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    NARRATOR:
    Hematologic adverse reactions, including thrombocytopenia, anemia, neutropenia, and/or pancytopenia, have been reported in patients receiving ZEJULA.

    The overall incidence of Grade 3 or higher 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 or higher 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 previous chemotherapy by achieving a Grade of 1 or less.

    Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, 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.


    ONSCREEN TEXT:
    Important Safety Information:
    Hematologic adverse reactions

    JOSHUA KESTERSON:
    Additional important safety information will be reviewed later in this presentation.


    ONSCREEN TEXT:
    ZEJULA has been approved in first-line maintenance with an individualized starting dose

    [Graphic] If weight <170 lb or baseline platelets <150,000/µL
    200 mg/day; First dose reduction: 100 mg/day; Second dose reduction: discontinue

    [Graphic] If weight ≥170 lb and baseline platelets ≥150,000/µL
    300 mg/day; First dose reduction: 200 mg/day; Second dose reduction: 100 mg/day; Third dose reduction: discontinue

    For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    Let’s begin our discussion on dosing by considering how the individualized starting dose can be used for patients taking ZEJULA.

    For first-line maintenance treatment of advanced ovarian cancer, the recommended starting dose of ZEJULA for patients who weigh less than one hundred seventy pounds or seventy-seven kilograms at baseline or have a baseline platelet count less than one hundred fifty thousand per microliter is 200 milligrams (two 100-milligrams capsules) taken orally once daily. For patients who weigh one hundred seventy pounds or seventy-seven kilograms or more at baseline and have a baseline platelet count of one hundred fifty thousand per microliter or more, the recommended starting dose is 300 milligrams (three 100-milligrams capsules) taken orally once daily.

    For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 milligrams once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.

    To manage adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. The recommended dose modifications for adverse reactions are listed on this slide.


    ONSCREEN TEXT:
    The discontinuation rate with ZEJULA in PRIMA was 12%

    [Graphic] 80%
    Dose reduction or interruption rate due to ARs in patients receiving ZEJULA, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%)

    [Graphic] 12%
    Treatment discontinuation rate due to ARs in patients receiving ZEJULA

    [Table] Discontinuation of ZEJULA due to hematologic ARs
    ARs; Discontinuations (%)
    Thrombocytopenia; 3.7
    Anemia; 1.9
    Neutropenia; 1.2

    AR, adverse reaction.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    In PRIMA, adverse reactions led to dose reduction or interruption in 80% of patients, who received ZEJULA, most frequently from thrombocytopenia in 56% of patients, anemia in 33% of patients, and neutropenia in 20% of patients.

    Treatment discontinuations due to adverse reactions occurred in 12% of patients receiving ZEJULA.

    Adverse reactions resulting in discontinuation of ZEJULA in 1% or more of patients included thrombocytopenia in 3.7% of patients, anemia in 1.9% of patients, and nausea and neutropenia in 1.2% of patients.


    ONSCREEN TEXT:
    Lower rates of select hematologic ARs were observed with an individualized starting dose

    PRIMA prospectively analyzed the safety and efficacy of an individualized starting dose of either 200 mg or 300 mg, selected based on baseline weight and platelet count, as well as a fixed starting dose of 300 mg

    [Column chart] Select grade ≥3 hematologic ARs in patients receiving ZEJULA
    [Y-axis] Patients (%)
    Overall population receiving ZEJULA as either a fixed starting dose of 300 mg/day or individualized starting dose of 200 mg/day or 300 mg/day (n=484); Individualized ZEJULA starting dose of 200 mg/day or 300 mg/day (n=169)
    Thrombocytopenia; 39; 21
    Anemia; 31; 23

    Neutropenia; 21; 15

    • Rates of grades 3–4 leukopenia were the same in the overall and individualized starting dose populations


    AR, adverse reaction.

    1. ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.


    JOSHUA KESTERSON:
    Now, let’s discuss the hematologic adverse reactions observed in PRIMA. Lower rates of select hematologic adverse reactions were observed with an individualized starting dose compared to the overall population receiving ZEJULA.

    PRIMA was initiated with a fixed starting dose of 300 milligrams for all patients. A protocol amendment incorporated individualized dosing, in which patients with baseline body weight of one hundred seventy pounds or more and a platelet count of one hundred fifty thousand per microliter or more received a starting dose of 300 milligrams and all other patients received a starting dose of 200 milligrams.

    Rates of select hematologic adverse reactions, including thrombocytopenia, anemia, and neutropenia, were observed to be lower with an individualized starting dose of ZEJULA compared to the overall population receiving ZEJULA. Rates of Grades 3 or 4 leukopenia were the same in the overall and individualized starting dose populations.


    ONSCREEN TEXT:
    The individualized starting dose was shown to be effective in exploratory subgroup analyses* and is the approved starting dose of ZEJULA in first-line maintenance1,2

    A reduction in risk of disease progression or death was observed with ZEJULA in patients taking an individualized starting dose based on weight and platelet count:
    [Graphic] 32%
    in the overall population (n=258) HR: 0.68 (95% CI: 0.48–0.97)1
    [Graphic] 61%
    in the HRd population (n=130) HR: 0.39 (95% CI: 0.22–0.72)1
    [Graphic] 71%
    in the BRCAm population (n=53) HR: 0.29 (95% CI: 0.13–0.67)2

    * These analyses are exploratory in nature, do not control for type 1 error, and are not powered to determine treatment effect in any subgroup.

    BRCA, breast cancer susceptibility gene; BRCAm, BRCA mutation; CI, confidence interval; HR, hazard ratio; HRd, homologous recombination deficient.

    1. ZEJULA. Prescribing Information. GlaxoSmithKline; 2021. 2. Korach J, Graybill W, Redondo A, et al. Niraparib in patients with newly advanced ovarian BRCAm cancer: a post hoc analysis of the PRIMA/ENGOT-OV26/GOG-3012 trial. Abstract presented at the European Society of Gynaecological Oncology (ESGO) Congress; December 14–16, 2020.

    JOSHUA KESTERSON:
    The individualized starting dose was shown to be effective in exploratory subgroup analyses and is the approved starting dose of ZEJULA in first-line maintenance.

    In these exploratory analyses, the hazard ratio for progression-free survival for patients taking an individualized starting dose was 0.68 in the overall population, 0.39 in the homologous recombination deficient population and 0.29 in the BRCA mutation population.

    These analyses are exploratory in nature, do not control for type 1 error, and are not powered to determine treatment effect in any subgroup.


    ONSCREEN TEXT:
    Monitoring complete blood counts, blood pressure, and heart rate helps identify the need to dose modify with ZEJULA

    [Graphic] Blood counts
    1st MONTH
    ONCE A WEEK;
    REST OF YEAR
    ONCE A MONTH;
    AFTER YEAR 1: MONITOR PERIODICALLY ONCE EVERY 2–3 MONTHS*
    *Schedule provided as an example.

    [Graphic] Blood pressure and heart rate
    1st and 2nd MONTHS
    ONCE A WEEK;
    REST OF YEAR
    ONCE A MONTH;
    AFTER YEAR 1: MONITOR PERIODICALLY ONCE EVERY 2–3 MONTHS*
    *Schedule provided as an example.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    Monitoring complete blood counts, blood pressure, and heart rate is required for safe administration and helps to identify the need to dose modify with ZEJULA.

    Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

    Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the rest of the first year, and periodically thereafter.

    These monitoring schedules are recommendations and health care providers should exercise clinical judgement when determining the best monitoring schedule for their patient.


    ONSCREEN TEXT:
    Dose modification to manage ARs
    [Graphic] Interrupt treatment prior to dose adjustment

    Non-hematologic
    CTCAE ≥Grade 3 adverse reaction that persists despite medical management
    Interrupt treatment for a maximum of 28 days*
    Resume at reduced dose following resolution

    Hematologic

    • Hematologic ARs requiring transfusion
    • Platelet count <100,000/μL
    • Neutrophil count <1,000/μL
    • Hemoglobin <8 g/dL

    Interrupt treatment for a maximum of 28 days*
    Obtain CBC weekly; Resume at same or reduced dose following resolution; Continue CBC weekly for an additional 4 weeks

    * If hematologic toxicities do not resolve within 28 days following interruption, discontinue ZEJULA and refer the patient to a hematologist for further investigations.
    Resume at the same dose only for the first occurrence of thrombocytopenia if platelets are >75,000/μL.

    AR, adverse reaction; CBC, complete blood count.; CTCAE, Common Terminology Criteria for Adverse Events.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    Let’s talk about how dose modification can be used to manage adverse reactions.

    For a Common Terminology Criteria for Adverse Event, or CTCAE, Grade 3 or greater non-hematologic treatment-related adverse reaction that persists despite medical management, interrupt treatment for up to 28 days and resume at a reduced dose following resolution. For a Grade 3 or greater adverse reaction lasting more than 28 days while patient is being administered ZEJULA 100 milligrams per day, discontinue ZEJULA.

    For hematologic adverse reactions such as those requiring transfusion, a platelet count of less than one hundred thousand per microliter, a neutrophil count of less than one thousand per microliter, or hemoglobin less than 8 grams per deciliter, withhold ZEJULA for up to 28 days. Monitor blood counts weekly until platelet counts return to one hundred thousand per microliter or greater, neutrophil counts return to one thousand five hundred per microliter or greater, or hemoglobin returns to 9 grams per deciliter or greater. Resume ZEJULA at the same or a reduced dose. If the platelet count is less than seventy-five thousand per microliter, resume at a reduced dose upon resolution.

    At the second occurrence of platelet count less than one hundred thousand per microliter, withhold and monitor as for first occurrence and resume after resolution at a reduced dose; discontinue ZEJULA if the platelet count does not return to acceptable levels within 28 days of dose interruption, or if the patient has already undergone dose reduction to 100 milligrams once daily.

    Discontinue ZEJULA if the neutrophil and/or hemoglobin count does not return to acceptable levels within 28 days of dose interruption, or if the patient has already undergone dose reduction to 100 milligrams once daily.

    For patients with a platelet count of ten thousand per microliter or less, platelet transfusion should be considered. If there are other risk factors such as co-administration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count. Resume ZEZULA at a reduced dose.

    Permanently discontinue ZEJULA if a diagnosis of MDS or AML is confirmed.


    ONSCREEN TEXT:
    ZEJULA: No starting dose adjustment necessary for most special populations or conditions

    [Graphic] Reduce the starting dosage of ZEJULA to 200 mg once daily
    For moderate hepatic impairment*
    Moderate: Total bilirubin ≥1.5–3x ULN and any AST level
    Monitor patients for hematologic toxicity and reduce the dose further, if needed.

    [Graphic] No dose adjustment necessary
    For food; Food does not significantly affect the absorption of niraparib
    For mild/moderate renal impairment; Mild: CLcr: 60–89 mL/min; Moderate: CLcr: 30–59 mL/min

    For mild hepatic impairment*; Mild: <1.5x ULN total bilirubin and any AST level or bilirubin ≤ ULN and AST > ULN
    For age; ≥65 years

    * The recommended starting dose of ZEJULA has not been established for patients with severe hepatic impairment (total bilirubin >3.0x ULN and any AST level).
    There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.

    AST, aspartate transaminase; CLcr, creatinine clearance; ULN, upper limit of normal.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    With ZEJULA, most special populations or conditions will not need a starting dose adjustment.

    For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 milligrams once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.

    Food does not significantly affect the absorption of niraparib; therefore, ZEJULA may be taken with or without meals.

    If a patient vomits or misses a dose of ZEJULA, an additional dose should not be taken. The next dose should be taken at the regularly scheduled time.

    No dose adjustment is necessary for patients with mild to moderate renal impairment. There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.

    No dose adjustment is needed in patients with mild hepatic impairment. The recommended starting dose of ZEJULA has not been established for patients with severe hepatic impairment.

    No dose adjustment is necessary for patients who are 65 years of age or older.


    ONSCREEN TEXT:
    ZEJULA: Once-daily oral dosing

    [Graphic] Can be taken any time of day
    Patients should take their dose at approximately the same time each day; Bedtime administration may be a potential method for managing nausea

    [Graphic] No drug–drug interactions

    No specific drug-drug interactions have been reported with ZEJULA*

    [Graphic] Store at room temperature
    Store at 20°C to 25°C (68°F to 77°F)

    [Graphic] Patients may wait up to 12 weeks after their final dose of chemotherapy before starting first-line maintenance treatment with ZEJULA

    * No clinical drug-drug interaction studies have been performed with ZEJULA.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    JOSHUA KESTERSON:
    ZEJULA offers convenient once-daily oral dosing.

    ZEJULA may be taken at any time of day; however, patients should take their dose of ZEJULA at approximately the same time each day.

    ZEJULA capsules should be swallowed whole.

    No specific drug-drug interactions have been reported with ZEJULA.

    ZEJULA should be stored at room temperature, 20 to 25 degrees Celsius or 68 to 77 degrees Fahrenheit, with excursions between 15 to 30 degrees Celsius or 59 to 86 degrees Fahrenheit permitted.

    Patients may wait up to 12 weeks after their final dose of chemotherapy before starting first-line maintenance treatment with ZEJULA.


    ONSCREEN TEXT:
    Important Safety Information:
    Hypertension and hypertensive crisis


    JOSHUA KESTERSON:
    Now, let’s review some additional important safety information for ZEJULA.


    ONSCREEN TEXT:
    Important Safety Information:
    Hypertension and hypertensive crisis

    Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA

     

    • In PRIMA, Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo, 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

     

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    NARRATOR:
    Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA.
    Grade 3 or 4 hypertension occurred in 6% of patients receiving ZEJULA versus 1% of patients receiving placebo in PRIMA, with no reported discontinuations.

    Monitor blood pressure and heart rate at least weekly for the first 2 months, then monthly for the first year, and periodically thereafter during treatment.

    Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

    • Manage hypertension with antihypertensive medications and adjust the ZEJULA dose, if necessary


    ONSCREEN TEXT:
    Important Safety Information:
    Posterior reversible encephalopathy syndrome (PRES)

    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


    PRES, posterior reversible encephalopathy syndrome.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.


    NARRATOR:
    Posterior reversible encephalopathy syndrome, or PRES, occurred in 0.1% of two thousand one hundred sixty-five patients treated with ZEJULA in clinical trials. PRES 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 of PRES requires confirmation by brain imaging. If PRES is suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown.


    ONSCREEN TEXT:
    Important Safety Information:
    Embryo-fetal toxicity and lactation, and allergic reactions to FD&C Yellow No. 5

    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 to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose


    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


    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

    NARRATOR:
    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 in breastfed infants from ZEJULA, advise lactating women not to breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose.

     

    ZEJULA capsules contain FD&C Yellow No. 5, also known as tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

    Although the overall incidence of such reactions in the general population is low, they are frequently seen in patients who also have aspirin hypersensitivity.


    ONSCREEN TEXT:
    Most common ARs and lab abnormalities in first-line maintenance for advanced ovarian cancer

    Most common ARs in the PRIMA trial of ZEJULA as first-line maintenance for 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%)


    [Table] Abnormal laboratory findings in ≥25% of all patients receiving ZEJULA in PRIMA
    Grades 1–4; ZEJULA (N=484); Placebo (N=244); Grades 3–4; ZEJULA (N=484); Placebo (N=244)
    Decreased hemoglobin; 87; 66; 29; 1
    Decreased platelets; 74; 13; 37; 0
    Decreased leukocytes; 71; 36; 9; 0
    Increased glucose; 66; 57; 3; 3
    Decreased neutrophils; 66; 25; 23; 1
    Decreased lymphocytes; 51; 29; 7; 3
    Increased alkaline phosphatase; 46; 21; 1; 0
    Increased creatinine; 40; 23; 0; 0
    Decreased magnesium; 36; 34; 1; 0
    Increased aspartate aminotransferase; 35; 17; 1; 0.4
    Increased alanine aminotransferase; 29; 17; 2; 1

    ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase.

    ZEJULA. Prescribing Information. GlaxoSmithKline; 2021.

     

    NARRATOR:
    This slide includes the most common adverse reactions in at least 10% of all patients who received ZEJULA in PRIMA and the most common lab abnormalities in at least 25% of patients who received treatment with ZEJULA.

    The most common adverse reactions, including Grades 1 through 4, in at least 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%)
    • aspartate aminotransferase or alanine aminotransferase elevation (14%)
    • acute kidney injury (12%)


    Common lab abnormalities including Grades 1 through 4 in at least 25% of patients who received treatment with 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%).


    ONSCREEN TEXT:
    Thank you for your attention

    For more information, please visit www.zejulahcp.com
    To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-835-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    Trademarks are property of their respective owners.
    [GSK logo]
    ©2022 GSK or licensor
    NRPSTBD220001 January 2022
    Produced in USA.


    JOSHUA KESTERSON:
    Thank you for your attention to this presentation.
    To report suspected adverse reactions, contact GSK or the FDA.
    Please refer to the full prescribing information at zejulahcp.com.
    If you have additional questions, please refer to zejulahcp.com.

ONCE-DAILY ZEJULA

IS APPROVED FOR FIRST-LINE MAINTENANCE IN ADULTS WITH PLATINUM-RESPONSIVE ADVANCED OVARIAN CANCER REGARDLESS OF BIOMARKER STATUS.1

Learn more about how ZEJULA works and who it may help.

VISIT THE SITE

Reference: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2021.