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    • Efficacy

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    • Gazyvaro® (obinutuzumab) in R/R FL

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    1. Therapy Areas
    2. Haematology
    3. Gazyvaro® (obinutuzumab) in R/R FL
    4. Efficacy

    Gazyvaro + bendamustine followed by Gazyvaro maintenance halved the risk of patients suffering disease progression or death vs bendamustine alone1

    Results from GADOLIN, adapted from Trnêný M et al. 2016.

    • Gazyvaro + bendamustine followed by Gazyvaro monotherapy more than doubled the median investigator-assessed PFS vs bendamustine alone1

    At a glance:

    PFS in the GADOLIN study

    OS in the GADOLIN study

    GADOLIN study design

    Gazyvaro + bendamustine followed by Gazyvaro maintenance significantly prolongs OS vs bendamustine2

     

    • 5.5 years after beginning treatment with Gazyvaro + bendamustine, the probability of patients surviving remained above 50%2

    Results from GADOLIN, adapted from Cheson BD et al. 2018.

    To learn more about which patients are suitable for Gazyvaro, download our eligibility guide 

    GADOLIN study design

    GADOLIN: study design2

     

    Primary endpoint

    • IRC-assessed PFS

     

    Secondary endpoints

    • Investigator-assessed PFS, OS, safety, DoR, BOR

    a81% of patients had FL.2

    b1:1 randomisation.c Each dose of Gazyvaro induction was 1000 mg and was administered on days 1, 8 and 15 of cycle 1, and day 1 of cycles 2–6. Bendamustine, in combination with Gazyvaro, was administered on days 1 and 2 for cycles 1–6 at 90 mg/m2/day. Each cycle was 28 days.2

    dBendamustine monotherapy was administered on days 1 and 2 of cycles 1–6 at 120 mg/m2/day. Different doses of bendamustine were used in each treatment arm as recommended by an international consensus panel of haematologists, guided by efficacy, safety and tolerability principles.2

    eEach dose of Gazyvaro maintenance was 1000 mg and was administered on day 1 of each cycle (up to 12 cycles).2

    Benda, bendamustine; BOR, best overall response; Cl, confidence interval; CR, complete response; DoR, duration of response; FL, follicular lymphoma; G, Gazyvaro; HR, hazard ratio; IRC, independent review committee; OS, overall survival; PFS, progression-free survival; R/R, relapsed/refractory; SD, stable disease.

     

    References:

    1. Trnêný M et al. Obinutuzumab plus bendamustine versus bendamustine alone in patients with rituximab-refractory follicular lymphoma: results from the GADOLIN study. EHA Annual Meeting 2016; Abstract S440.
    2. Cheson BD et al. J Clin Oncol. 2018;36(22):2259-2266.


    M-GB-00000247
    Date of preparation: June 2020

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