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    • Efficacy

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    • Gazyvaro® (obinutuzumab) in CLL

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    1. Therapy Areas
    2. Haematology
    3. Gazyvaro® (obinutuzumab) in CLL
    4. Efficacy

    Gazyvaro + Clb reduced the risk of death by 24% vs rituximab + Clb1

    • In an open-label, multicentre, randomised, phase III study in previously untreated CLL patients with comorbidities:
      – Gazyvaro + Clb met the primary endpoint of improved PFS vs rituximab + Clb1-3
      – Median OS for rituximab + Clb was 73.1 months while Gazyvaro + Clb had yet to reach median OS at 7 years1

    Secondary endpoint: OS1

    Adapted from Goede et al. 2018.

    At a glance:

    OS in the CLL11 study

    PFS in the CLL11 study

    CLL11 study design

    Treatment with Gazyvaro + Clb significantly prolonged PFS compared with rituximab + Clb 1

    • Gazyvaro + Clb reduced the risk of disease progression or death by 51% vs rituximab + Clb (13.2-month absolute improvement in median PFS; HR=0.49; 95% CI, 0.41–0.58; p<0.0001)1:
      – Median PFS was 28.9 months for Gazyvaro + Clb vs 15.7 months with rituximab + Clb1

    Primary endpoint: PFS1

    Adapted from Goede et al. 2018.

    •  Gazyvaro + Clb reduced the risk of disease progression or death by 82% vs Clb (15.6-month absolute improvement in median PFS; HR=0.18; 95% CI, 0.13–0.24; p<0.001)3

    CLL11 study design

    Learn more about safety and tolerability with Gazyvaro

    Adapted from Goede et al. 2014.

    CLL11 study design

    Download our dosing and administration guide

    CLL11: study design1

    Primary endpoint

    •  PFS (investigator-assessed)

     

    Secondary endpoints

    •  OS, TTNT, MRD, safety

     

    Open-label, randomised phase III study in previously untreated CLL patients with coexisting medical conditions*

    Adapted from Goede et al. 2018.
    *NCT01010061.
    †Dose split over two days.

    Chemo, chemotherapy; CI, confidence interval; CIRS, cumulative illness rating scale; Clb, chlorambucil; CLL, chronic lymphocytic leukaemia; CrCl, creatinine clearance; FL, follicular lymphoma; G, Gazyvaro; HR, hazard ratio; ITT, intent-to-treat; IV, intravenous; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; R, rituximab; TTNT, time to next treatment.

    References:

    1. Goede V et al. Abstract S151 presented at EHA 2018, Stockholm.
    2. Goede V et al. Leukemia 2015; 29: 1602–1604.
    3. Goede V et al. N Engl J Med 2014; 370: 1101-1110 and supplementary appendices.

     


    M-GB-00001845
    Date of preparation: October 2020

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