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    AboutAbout

    Mechanism of ActionNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)Identifying Patients With gBRCA Mutations
    Efficacy & SafetyEfficacy & SafetyStudy DesignEfficacySafety profileDosingDosing

    Dosing and Modifications
    Support & OrderSupport & Order

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    Efficacy​​​​​​​

    Primary endpoint: PFS

    TALZENNA was superior to chemotherapy* in delaying disease progression​​​​​​​

    Kaplan-Meier Curves of PFS

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    ** This is an optional area where footnotes can live.

      *Capecitabine, eribulin, gemcitabine, vinorelbine.

        †Hazard ratio is estimated from a Cox proportional hazards model stratified by prior use of chemotherapy for metastatic disease (0 vs 1, 2, or 3), by TNBC status (TNBC vs non-TNBC), and by history of CNS metastasis (yes vs no).

       ‡P values from stratified log-rank test (2-sided).

    Announcement Title

    Nearly twice as many patients remained on TALZENNA without disease progression or death at 1 year vs chemotherapy (37% vs 20%)2

    Consistent PFS results were observed across patient subgroups defined by number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases1

    PFS according to prespecified subgroups2,3

    • The below table depicts subgroup analyses from the overall EMBRACA study population. Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups

    ** This is an optional area where footnotes can live.

    Additional endpoints

    Secondary endpoint: objective response rate (ORR)​​​​​​​

    TALZENNA more than doubled ORR vs chemotherapy1​​​​​​​

    ​​​​​​​Confirmed ORR§||

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    • Unconfirmed ORR||¶—Unconfirmed ORR was 62.6% (95% CI: 55.8-69.0) for patients treated with TALZENNA vs 27.2% (95% CI: 19.3-36.3) for patients treated with chemotherapy2
      • Complete response||¶—5.5% achieved a complete response with TALZENNA vs 0% with chemotherapy2
      • Partial response||¶—57.1% achieved a partial response with TALZENNA vs 27.2% with chemotherapy2
      • Time to response¶#—the median time to response was 2.6 months for the TALZENNA group and 1.7 months for the chemotherapy group2

    Secondary endpoint: overall survival (OS)

    • Final OS analysis did not reach statistical significance4
      • Median OS: 19.3 months (95% CI: 16.6-22.5) with TALZENNA vs 19.5 months (95% CI: 17.4-22.4) with chemotherapy (HR=0.85 [95% CI: 0.67-1.07]; P=0.17)

    Exploratory endpoint: duration of response (DoR)

    • Median DoR was longer with TALZENNA vs chemotherapy: 6.4 months (95% CI: 5.4-9.5) with TALZENNA vs 3.9 months (95% CI: 3.0-7.6) with chemotherapy1#​​​​​​​

        §Response rate based on confirmed responses. Confirmed response: best overall response of partial response or complete response, confirmed by a subsequent tumor assessment (at least 4 weeks later) by investigator assessment.

        ||Conducted in intent-to-treat (ITT) population with measurable disease at baseline.

        ¶Includes patients with confirmed and unconfirmed responses.

        #Analyzed in the ITT patients who experienced an objective response as assessed by the investigator.


    References:
    1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2020.
    2. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.
    3. Data on file. Pfizer Inc., New York, NY.
    4. Litton JK, Hurvitz SA, Mina LA, et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020. doi:10.1016/j.annonc.2020.08.2098.

    GIVE YOUR PATIENTS A BIOMARKER-DRIVEN TREATMENT THAT'S ​​​​​​​JUST FOR THEM

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    Efficacy & Safety

    • Study Design
    • Efficacy
    • Safety Profile

    Mechanism of action

    TALZENNA is an inhibitor of PARP enzymes, including PARP1 and PARP2, which play a role in DNA repair​​​​​​​1

    Review the MOA

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    Convenient once-daily dosing​​​​​​​1

    The recommended starting dose of TALZENNA is 1 mg taken orally once daily1

    See dosing information

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    Safety and tolerability profile

    The safety of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study1,2

    Review safety profile

    ** This is an optional area where footnotes can live.

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these two patients prior to developing MDS/AML was 4 months and 24 months, respectively. Both patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

    Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 39%, 21%, and 15% of patients receiving TALZENNA. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

    Monitor complete blood counts for cytopenia at baseline and monthly thereafter. Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. If hematological toxicity occurs, dose modifications (dosing interruption with or without dose reduction) are recommended. With respect to MDS/AML, for prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If the levels have not recovered after 4 weeks, refer the patient to a hematologist for further investigations. If MDS/AML is confirmed, discontinue TALZENNA.

    TALZENNA can cause fetal harm when administered to pregnant women. Advise women of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose. A pregnancy test is recommended for females of reproductive potential prior to initiating TALZENNA treatment. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for at least 4 months after receiving the last dose. Based on animal studies, TALZENNA may impair fertility in males of reproductive potential. Advise women not to breastfeed while taking TALZENNA and for at least 1 month after receiving the last dose because of the potential for serious adverse reactions in nursing infants.

    The most common adverse reactions (≥20%) of any grade for TALZENNA vs chemotherapy were fatigue (62% vs 50%), anemia (53% vs 18%), nausea (49% vs 47%), neutropenia (35% vs 43%), headache (33% vs 22%), thrombocytopenia (27% vs 7%), vomiting (25% vs 23%), alopecia (25% vs 28%), diarrhea (22% vs 26%), and decreased appetite (21% vs 22%).

    The most frequently reported Grade ≥3 adverse reactions (≥10%) for TALZENNA vs chemotherapy were anemia (39% vs 5%), neutropenia (21% vs 35%), and thrombocytopenia (15% vs 2%).

    The most common lab abnormalities (≥25%) for TALZENNA vs chemotherapy were decreases in hemoglobin (90% vs 77%), leukocytes (84% vs 73%), lymphocytes (76% vs 53%), neutrophils (68% vs 70%), platelets (55% vs 29%), and calcium (28% vs 16%) and increases in glucose (54% vs 51%), aspartate aminotransferase (37% vs 48%), alkaline phosphatase (36% vs 34%), and alanine aminotransferase (33% vs 37%).

    Coadministration with P-gp inhibitors or BCRP inhibitors may increase TALZENNA exposure. If coadministering with the P-gp inhibitors amiodarone, carvedilol, clarithromycin, itraconazole, or verapamil is unavoidable, reduce the TALZENNA dose to 0.75 mg once daily. When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor. When coadministering TALZENNA with other known P-gp inhibitors or BCRP inhibitors, monitor patients for potential increased adverse reactions.

    For patients with moderate renal impairment, the recommended dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment, the recommended dose of TALZENNA is 0.5 mg once daily. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

    TALZENNA has not been studied in patients with moderate or severe hepatic impairment. No dose adjustment is required for patients with mild hepatic impairment.

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA ​​​​​.

    Please see full Prescribing Information.

    Indication

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.