ZEJULA Logo

EFFICACY & SAFETY DATA IN HRd ADVANCED OVARIAN CANCER PATIENTS

Explore the clinical data showing the efficacy of ZEJULA and its established safety and tolerability profile. Then, review 5 reasons to consider ZEJULA for your appropriate patients.

Explore the clinical data showing the efficacy of ZEJULA and its established safety and tolerability profile. Then, review 5 reasons to consider ZEJULA for your appropriate patients.

  • VIDEO TRANSCRIPT | 14:04

    VO: In platinum-responsive advanced ovarian cancer:
    Proven Efficacy in 1L Maintenance for HRd Patients

    TEXT ON SCREEN: In platinum-responsive advanced ovarian cancer:
    PROVEN EFFICACY IN 1L MAINTENANCE FOR HRd PATIENTS

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.

    1L, first-line; HRd, homologous recombination deficient.


    VO: Poly (ADP-ribose) polymerase, or PARP, inhibitors have been proven effective at prolonging progression-free survival, or PFS, versus placebo in first-line maintenance treatment of advanced ovarian cancer after complete or partial response to platinum-based chemotherapy.

    TEXT ON SCREEN: PARP inhibitors (PARPis) have been PROVEN EFFECTIVE at prolonging PFS vs placebo in first-line maintenance treatment of advanced ovarian cancer.1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: However, first-line maintenance therapy with a PARPi was previously only approved in patients with a mutation in the breast cancer susceptibility gene, known as BRCAm.

    TEXT ON SCREEN: Previously, first-line maintenance therapy with a PARPi was only approved in BRCAm PATIENTS.3

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: ZEJULA (niraparib) is the only once-daily oral PARPi monotherapy approved for first-line platinum responders with advanced ovarian cancer, regardless of biomarker status.

    TEXT ON SCREEN: ZEJULA (niraparib) is approved for first-line platinum responders, regardless of biomarker status.1-4

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: None

    TEXT ON SCREEN: Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: 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.

    Important Safety Information. 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.

    TEXT ON SCREEN:
    Indication
    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.

    Important Safety Information

    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.


    VO: 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.

    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.

    TEXT ON SCREEN: 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.

    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.


    VO: 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.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.

    TEXT ON SCREEN: 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.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Let’s explore the clinical data showing the efficacy of ZEJULA in first-line platinum responders.

    TEXT ON SCREEN: PRIMA TRIAL
    ZEJULA EFFICACY IN FIRST-LINE PLATINUM RESPONDERS

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In PRIMA, the efficacy and safety of ZEJULA versus placebo were evaluated in 733 newly diagnosed advanced ovarian cancer patients who had a complete or partial response to first-line platinum-based chemotherapy.

    TEXT ON SCREEN: PRIMA TRIAL

    ZEJULA VS PLACEBO IN 733 PATIENTS with complete or partial response to first-line platinum-based chemotherapy1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the PRIMA trial, patients were randomized…

    TEXT ON SCREEN: Patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer at risk for recurrence after response to 1L platinum-based chemotherapy.

    2:1 Randomization* (N=733)

    *Patients were stratified based on neoadjuvant chemotherapy administered (yes or no), best response to first-line platinum therapy (complete response or partial response), and homologous recombination (HR) status (deficient [HRd], proficient [HRp], or not determined).2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: …to ZEJULA or placebo once daily.

    TEXT ON SCREEN: Patients with:
    –Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
    –Complete or partial response to first-line platinum-based chemotherapy

    2:1 Randomization* (N=733)

    ZEJULA*†
    once daily (n=487)

    Placebo
    once daily (n=246)

    *Patients were stratified based on neoadjuvant chemotherapy administered (yes or no), best response to first-line platinum therapy (complete response or partial response), and homologous recombination (HR) status (deficient [HRd], proficient [HRp], or not determined).2
    Patients in PRIMA received a starting dose of either 200 or 300 mg based on their baseline body weight or platelet count (n=258), or a fixed starting dose of 300 mg per day (n=475) regardless of body weight or platelet count.2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Primary endpoints of the PRIMA trial were median PFS in patients who had tumors with homologous recombination deficiency, and median PFS in the overall population.

    TEXT ON SCREEN: ZEJULA*†
    once daily (n=487)

    Placebo
    once daily (n=246)

    Primary endpoints1,2

    Median PFS in patients who had tumors with homologous recombination deficiency

    Median PFS in the overall population

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.



    VO: Overall, ZEJULA significantly increased PFS versus placebo.

    TEXT ON SCREEN: ZEJULA significantly increased PFS vs placebo.1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the overall population, consisting of 733 patients,

    TEXT ON SCREEN: Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: there was a 38% reduction in risk of progression or death with ZEJULA versus placebo.

    TEXT ON SCREEN: PFS in the overall population (N=733)1,2

    38% reduction in risk of progression or death with ZEJULA vs placebo


    Hazard ratio 0.62 (95% CI, 0.50-0.76)
    P<0.0001

    ZEJULA (n=487)*

    Placebo (n=246)*


    *Censored subjects are indicated by circles.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Median PFS was 13.8 months with ZEJULA versus 8.2 months with placebo.

    TEXT ON SCREEN: PFS in the overall population (N=733)1,2

    13.8 MONTHS MEDIAN PFS [ZEJULA]
    8.2 MONTHS MEDIAN PFS [PLACEBO]

    38% reduction in risk of progression or death with ZEJULA vs placebo

    Hazard ratio 0.62 (95% CI, 0.50-0.76)
    P<0.0001

    ZEJULA (n=487)*

    Placebo (n=246)*


    *Censored subjects are indicated by circles.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the homologous recombination deficient, or HRd population, which consisted of 373 patients, there was a 57% reduction in risk of progression or death with ZEJULA versus placebo.

    TEXT ON SCREEN: PFS in the HRd population (n=373)1,2

    57% reduction in risk of progression or death with ZEJULA vs placebo


    Hazard ratio 0.43 (95% CI, 0.31-0.59)
    P<0.0001

    ZEJULA (n=247)*

    Placebo (n=126)*


    *Censored subjects are indicated by circles.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: ZEJULA more than doubled median PFS versus placebo, resulting in 21.9 months with ZEJULA and 10.4 months with placebo.

    TEXT ON SCREEN: PFS in the HRd population (n=373)1,2

    21.9 MONTHS MEDIAN PFS [ZEJULA]
    10.4 MONTHS MEDIAN PFS [PLACEBO]

    57% reduction in risk of progression or death with ZEJULA vs placebo

    Hazard ratio 0.43 (95% CI, 0.31-0.59)
    P<0.0001

    ZEJULA (n=247)*

    Placebo (n=126)*


    *Censored subjects are indicated by circles.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Improvements in PFS…

    TEXT ON SCREEN: Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: …were seen in both the HRd and overall study populations.

    TEXT ON SCREEN: Improvements in PFS were seen in both the HRd and overall study populations.1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Prespecified exploratory analyses of the BRCAm and HRd BRCAwt subgroups were performed. Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.

    TEXT ON SCREEN: Prespecified exploratory analyses of the BRCAm and HRd BRCAwt subgroups were performed1

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the exploratory analysis of the BRCAm population, a 60% reduction in risk of progression or death was observed with ZEJULA versus placebo.

    TEXT ON SCREEN: PFS in the BRCAm population (n=223)1

    60% reduction in risk of progression or death observed in BRCAm patients1

    Hazard ratio 0.40 (95% CI, 0.27-0.62)

    22.1 MONTHS MEDIAN PFS [ZEJULA]
    10.9 MONTHS MEDIAN PFS [PLACEBO]

    ZEJULA (n=152)*
    Placebo (n=71)*


    *Censored subjects are indicated by circles.
    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the exploratory analysis of the HRd BRCAwt population, a 50% reduction in risk of progression or death was observed with ZEJULA versus placebo.

    TEXT ON SCREEN: PFS in the HRd BRCAwt population (n=150)1

    50% reduction in risk of progression or death observed in BRCAwt patients1

    Hazard ratio 0.50 (95% CI, 0.31-0.83)

    19.6 MONTHS MEDIAN PFS [ZEJULA]
    8.2 MONTHS MEDIAN PFS [Placebo]

    ZEJULA (n=95)*
    Placebo (n=55)*


    *Censored subjects are indicated by circles.
    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: Reduced risk of disease progression was observed…

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS
    (months)

    ZEJULA
    Median PFS
    (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    Homologous
    recombination
    status
         
    BRCA mutation
    (n=233, 30%)
    0.40 (0.27-0.62) 22.1 10.9


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: …with ZEJULA versus placebo across multiple patient subgroups.

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS (months)

    ZEJULA
    Median PFS (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    No BRCA mutation, homologous recombination deficient (n=150, 20%) 0.50 (0.31-0.83) 19.6 8.2
    Homologous recombination proficient (n=249, 34%) 0.68 (0.49-0.94) 8.1 5.4


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: These prespecified subgroup analyses are exploratory in nature…

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS (months)

    ZEJULA
    Median PFS (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    Not determined (n=111, 15%) 0.85 (0.51-1.43)    
    Stage of disease at initial diagnosis      
    III (n=476, 65%) 0.54 (0.42-0.70)    


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: …and were not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

     

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS (months)

    ZEJULA
    Median PFS (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    IV (n=257, 35%) 0.79 (0.55-1.12)    
    Neoadjuvant chemotherapy      
    Yes (n=489, 67%) 0.59 (0.46-0.76)    


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: At the time of the PFS analysis, limited overall survival data were available,

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

     

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS (months)

    ZEJULA
    Median PFS (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    No (n=244, 33%) 0.66 (0.46-0.94)    
    Best response to platinum therapy      
    Complete response (n=509, 69%) 0.60 (0.46-0.77)    


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: with 11% deaths in the overall population.

    TEXT ON SCREEN: Reduced risk of disease progression was observed with ZEJULA vs placebo across multiple patient subgroups1,2

    Patient Subgroup Hazard Ratio for
    Disease
    Progression or
    Death (95% CI)
    Median PFS (months)

    ZEJULA
    Median PFS (months)

    Placebo
    All patients
    (N=733)
    0.62 (0.50-0.76) 13.8 8.2
    Best response to platinum therapy      
    Complete response (n=509, 69%) 0.60 (0.46-0.77)    
    Partial response (n=224, 31%) 0.60 (0.43-0.85)    


    At the time of the PFS analysis, limited overall survival data were available, with 11% deaths in the overall population.2

    Because these analyses were exploratory and not powered to detect a statistically significant treatment effect, results should be interpreted with caution.1

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the PRIMA trial, ZEJULA had an established safety and tolerability profile, consistent with previous clinical trial experience. This chart shows adverse reactions reported in greater than or equal to 10% of all patients receiving ZEJULA, or niraparib, in PRIMA. These included thrombocytopenia (66%), anemia (64%), nausea (57%),

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*

    ZEJULA Grades 1-4   Placebo Grades 1-4
    66 Thrombocytopenia 5
    64 Anemia 18
    57 Nausea 28
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: fatigue (51%), neutropenia (42%), constipation (40%),

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*

    ZEJULA Grades 1-4   Placebo Grades 1-4
    51 Fatigue 41
    42 Neutropenia 8
    40 Constipation 20
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: musculoskeletal pain (39%), leukopenia (28%), headache (26%),

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*

    ZEJULA Grades 1-4   Placebo Grades 1-4
    39 Musculoskeletal Pain 38
    28 Leukopenia 9
    26 Headache 15
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: insomnia (25%), vomiting (22%), dyspnea (22%),

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*


    ZEJULA Grades 1-4   Placebo Grades 1-4
    25 Insomnia 15
    22 Vomiting 12
    22 Dyspnea 13
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: decreased appetite (19%), dizziness (19%), cough (18%),

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*


    ZEJULA Grades 1-4   Placebo Grades 1-4
    19 Decreased Appetite 8
    19 Dizziness 13
    18 Cough 15
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%).

    TEXT ON SCREEN: ZEJULA has an established safety and tolerability profile.1,2

    Adverse reactions reported in ≥10% of all patients receiving ZEJULA in PRIMA2*


    ZEJULA Grades 1-4   Placebo Grades 1-4
    18 Hypertension 7
    14 AST/ALT Elevation 7
    12 Acute Kidney Injury§ 5
    Patient % (n=484)   Patient % (n=244)


    ZEJULA
    Grades 1-4||

    Placebo
    Grades 1-4||

    *All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
    Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
    Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
    §Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
    IICommon Terminology Criteria for Adverse Events version 4.02.

    AST/ALT, aspartate transaminase/alanine aminotransferase.

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: 12% of patients in the overall population discontinued treatment with ZEJULA due to adverse reactions, or ARs.

    TEXT ON SCREEN: 12% discontinued due to ARs.1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: ARs resulting in discontinuation of ZEJULA in greater than 1% of patients included thrombocytopenia (3.7%), anemia (1.9%), and nausea and neutropenia (1.2% each).

    TEXT ON SCREEN: ARs resulting in discontinuation in >1% of patients2:

    • thrombocytopenia (3.7%)
    • anemia (1.9%)
    • nausea and neutropenia (1.2% each)


    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: In the overall population in PRIMA, adverse reactions led to dose reduction or interruption in 80% of all patients, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%).

    Appropriate dose interruption and modification may help manage adverse reactions with ZEJULA.

    Additional Safety Information appears at the end of this video.

    TEXT ON SCREEN: Most frequent ARs leading to dose reduction or interruption in 80% of all patients2:

    • thrombocytopenia (56%)
    • anemia (33%)
    • neutropenia (20%)


    Appropriate dose interruption and modification may help manage adverse reactions with ZEJULA.1,2

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: 5 reasons to consider ZEJULA as a first-line maintenance therapy option for your eligible patients with platinum-responsive advanced ovarian cancer.

    TEXT ON SCREEN: 5 reasons to consider ZEJULA as a first-line maintenance therapy option for your eligible patients with platinum-responsive advanced ovarian cancer

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: First, the PRIMA trial demonstrated that ZEJULA significantly increased PFS versus placebo in the overall and HRd populations and had a safety profile consistent with previous clinical trial experience.

    TEXT ON SCREEN: Please see additional Important Safety Information throughout this presentation and full Prescribing Information.

    01
    ZEJULA significantly increased PFS vs placebo in the overall and HRd populations and had a safety profile consistent with previous clinical trial experience.1,2


    VO: Second, ZEJULA is the only once-daily PARP inhibitor monotherapy available for HRd patients.

    TEXT ON SCREEN: 02
    ZEJULA is the only once-daily PARP inhibitor monotherapy available for HRd patients.1-4


    VO: Third, ZEJULA is the only PARPi approved with an individualized starting dose in first-line maintenance.

    TEXT ON SCREEN: 03
    ZEJULA is the only PARPi approved with an individualized starting dose in first-line maintenance.1-4


    VO: Fourth, ZEJULA is the only once-daily oral PARPi monotherapy in first-line maintenance treatment for advanced ovarian cancer.

    TEXT ON SCREEN: 04
    ZEJULA is the only once-daily oral PARPi monotherapy in first-line maintenance treatment for advanced ovarian cancer.1-4


    VO: Fifth, guidelines include ZEJULA as a recommended option.

    TEXT ON SCREEN: 05
    Guidelines include ZEJULA as a recommended option.5

    Please see additional Important Safety Information throughout this presentation and full Prescribing Information.


    VO: 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.

    TEXT ON SCREEN: Important Safety Information (continued)

    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.


    VO: 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 final dose.

    TEXT ON SCREEN: 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 final dose.


    VO: 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.

    The 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…

    TEXT ON SCREEN: 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.

    The 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…


    VO: …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 additional Important Safety Information throughout this presentation and full Prescribing Information.

    TEXT ON SCREEN: 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 additional Important Safety Information throughout this presentation and full Prescribing Information.


    TEXT ON SCREEN: Visit zejulahcp.com to learn more.

    Please see Full Prescribing Information.

    Trademarks are property of their respective owners.

    [GSK logo]
    ©2022 GSK or licensor.
    NRPVID210039 January 2022
    Produced in USA.


    TEXT ON SCREEN: References: 1. González-Martín A, Pothuri B, Vergote I, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):2391-2402. doi: 10.1056/NEJMoa1910962 2. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2021. 3. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP; 2021. 4. Rubraca (rucaparib). Prescribing Information. Clovis Oncology, Inc; 2021. 5. Tew WP, Lacchetti C, Ellis A. PARP inhibitors in the management of ovarian cancer: ASCO guideline. J Clin Oncol. 2020;38(30):3468-3493. doi: 10.1200/JCO.20.01924

    Please see Full Prescribing Information.

    Trademarks are property of their respective owners.

    [GSK logo]
    ©2022 GSK or licensor.
    NRPVID210039 January 2022
    Produced in USA.

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.