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    1. Therapy Areas
    2. Haematology
    3. Gazyvaro® (obinutuzumab) in 1L FL
    4. Safety & QoL

    Similar safety profiles were observed for both treatment arms1


    In the GALLIUM study:

    • More patients had grade 3–5 AEs with Gazyvaro than rituximab, but no new safety signals were observed1,2
    • The frequency of AEs leading to discontinuation and fatal AEs were similar between treatment groups2
    • Safety data in the updated analysis are consistent with those reported in the primary analysis3

    Patients experiencing AEs1

    Results from GALLIUM, adapted from Hiddemann et al. 2017.

    *Includes six patients with fatal AEs that occurred after start of new anti-cancer therapy (4 G + benda + G; 2 R + benda + R).

    Selected grade ≥3 AEs of particular interest occurring in >2% of patients in either arm1

    Results from GALLIUM, adapted from Hiddemann et al. 2017.

    At a glance:

    AEs

    Secondary malignancies

    IRRs

    QoL

    GALLIUM study design

    Rate of second malignancies2


    Second neoplasms by SMQ ‘malignant’ or ‘unspecified tumours’ occurring >6 months after treatment initiation2

    Results from GALLIUM, adapted from Marcus et al. 2017.

    †Includes prostate, breast and colon cancers.

     GALLIUM study design

    IRRs with Gazyvaro were manageable and rates decreased markedly after the first treatment cycle4

     

    •  Most IRRs were grade 1–2 in severity2

     

    Patients experiencing IRRs4‡

    Results from GALLIUM, adapted from Roche Data on File.

    ‡An IRR is any reaction occurring during or within 24 hours of infusion of Gazyvaro or rituximab and considered to be drug-related.

    Discover how to dose and administer Gazyvaro

    GALLIUM study design

    Despite AEs, patients’ quality of ‘normal’ life wasn’t compromised with Gazyvaro1,2,5

     

    •  There were no clear differences in FACT-Lym Total scores between treatment groups at any time point5

     

    Mean change in baseline in FACT-Lym Total by treatment arm5

    Results from GALLIUM, adapted from Davies et al. 2017.

     

    FACT-Lym Total included: lymphoma specific (15 questions), physical wellbeing (7 questions), functional wellbeing (7 questions), emotional wellbeing (6 questions) and social/family wellbeing (7 questions).5

     See the PFS data from the GALLIUM study

     GALLIUM study design

    GALLIUM: study design2

    Key to the significance of the results, the GALLIUM study was designed in collaboration with the NCRI (UK), GLSG (Germany) and the OSHO (Germany) to investigate Gazyvaro vs rituximab, where each arm was combined with chemotherapy in first-line advanced FL.2


    The sample size was calculated to give the trial 80% power to detect a difference in PFS that corresponded to a 26% lower risk of progression, relapse or death with Gazyvaro vs rituximab (HR=0.74) at α=0.05 (two-sided log-rank test).2

    Primary endpoint

    • Investigator-assessed PFS

     

    Secondary endpoints
    •   IRC-assessed PFS, overall survival, overall response rate at EOI (+/- FDG-PET), event-free survival, disease-free survival, duration of response, TTNT, safety

     

    Exploratory endpoints
    •    POD24, PET-CR, MRD, DLBCL transformation, PK, PD

    An open-label, multicentre, randomised phase III study2

    aCHOP or CVP (8 cycles) or bendamustine (6 cycles). Anti-CD20 + CHOP was administered for the first 6 cycles, with anti-CD20 immunotherapy administered alone for the 2 remaining cycles.

    1L, first-line; AE, adverse event; chemo, chemotherapy; CHOP, cyclophosphamide, doxorubicin, vincristine and prednisolone; CR, complete response; CVP, cyclophosphamide, vincristine and prednisolone; DLBCL, diffuse large B-cell lymphoma; EOI, end of induction; FACT-Lym, Functional Assessment of Cancer Therapy-Lymphoma; FDG, fluorodeoxyglucose; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; G, Gazyvaro; HR, hazard ratio; IRC, independent review committee; IRR, infusion-related reaction; MRD, minimal residual disease; PD, pharmacodynamics; PET, positron emission tomography; PFS, progression-free survival; PK, pharmacokinetics; POD24, progression of disease within 24 months post-randomisation; PR, partial response; QoL, quality of life; R, rituximab; SMQ, standardised MedDRA queries; TTNT, time to next treatment.


    References:

    1. Hiddemann W et al. EHA Annual Meeting 2017; abstract S775 and oral presentation.
    2. Marcus R et al. N Engl J Med 2017; 377(14): 1331–1344.
    3. Townsend W et al. ASH Annual Meeting 2018; abstract 1597.
    4. M-GB-00000421 Roche Data on File.
    5. Davies A et al 2017 oral presentation.
     
     
    M-GB-00000092
    Date of preparation: June 2020

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