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Identifying Appropriate Candidates for ZEJULA

Learn about hypothetical patients who may be appropriate candidates for ZEJULA from Dr. Joshua Kesterson.

Learn about hypothetical patients who may be appropriate candidates for ZEJULA from Dr. Joshua Kesterson.

  • VIDEO TRANSCRIPT | 09:10

    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:
    Patient Profiles

    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 the profiles of hypothetical patients who may be appropriate candidates for 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/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:
    Rita is BRCAm and at high risk of progression

    [Table] Clinical Profile
    BRCAm
    Age: 60
    PS0
    Diagnosed stage IV
    Neoadjuvant chemotherapy received ahead of suboptimal resection (R1)
    Complete response following first-line platinum-based chemotherapy

    [Table] Considerations Works part-time and lives alone, with a moderate support network
    Wants to try and resume life with a treatment option that fits into her routine

    [Photograph] Woman; not a real patient

    BRCA, breast cancer susceptibility gene; BRCAm, BRCA mutation; PS, Eastern Cooperative Oncology Group Performance Status; R, resection margin.

    JOSHUA KESTERSON:
    Let’s now talk about some typical patients that you may see in your practice daily.
    Our first patient is Rita. Rita is 60 years old, works part-time, and lives alone. She was diagnosed with stage IV ovarian cancer. She is BRCA-mutated, has a performance status of 0, and received neoadjuvant chemotherapy ahead of a suboptimal resection. She had a complete response following first-line platinum-based chemotherapy.
    Rita has a moderate support network and wants to try to resume life with a treatment option that fits into her routine.


    ONSCREEN TEXT:
    Silvia is young, BRCAm, and highly motivated

    [Table] Clinical Profile
    BRCAm
    Age: 49
    PS0 with no comorbidities
    Diagnosed stage IIIa, low-volume disease
    Optimally resected (R0)
    No evidence of disease following first-line platinum-based chemotherapy

    [Table] Considerations Active, working, excellent support network from family and friends

    [Photograph] Woman; not a real patient

    BRCA, breast cancer susceptibility gene; BRCAm, BRCA mutation; PS, Eastern Cooperative Oncology Group Performance Status; R, resection margin.

    JOSHUA KESTERSON:
    Our second patient is Silvia. Silvia is 49 years old and was diagnosed with stage IIIa ovarian cancer low-volume disease. She is BRCA mutated, has a performance status of 0 with no comorbidities, and was optimally resected. Following first-line platinum-based chemotherapy, there was no evidence of disease.
    Silvia is active, working, and has excellent support from family and friends.


    ONSCREEN TEXT:
    Elena is HRd BRCAwt and determined

    [Table] Clinical Profile
    BRCAwt
    Age: 55
    PS0
    Diagnosed IIIc
    Optimally resected (R0)
    No evidence of disease following first-line platinum-based chemotherapy

    [Table] Considerations Busy and active lifestyle
    Would like to take an active role in her treatment

    [Photograph] Woman; not a real patient

    BRCA, breast cancer susceptibility gene; BRCAwt, BRCA wild-type; PS, Eastern Cooperative Oncology Group Performance Status; R, resection margin.

    JOSHUA KESTERSON:
    Our third patient is Elena. Elena is 55 years old and was diagnosed with stage IIIc ovarian cancer. She is homologous recombination deficient, BRCA wild-type, has a performance status of 0, and was optimally resected. There was no evidence of disease following first-line platinum-based chemotherapy.
    Elena has a busy, active lifestyle and would like to take an active role in her treatment.

     

    Now may be the time to talk to your patients about maintenance treatment. Would you consider ZEJULA for appropriate patients, similar to those presented today?
    Now, let’s review some additional important safety information.


    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
    NRPSTBD220002 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

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