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    Home > Active Ingredient News > Antitumor Therapy > JCO: Efficacy and safety of Atezolizumab + bevacizumab + chemotherapy in the initial diagnosis of stage III or IV ovarian cancer: a placebo-controlled randomized phase III study (IMagyn050/GOG ​​3015/ENGOT- OV39)

    JCO: Efficacy and safety of Atezolizumab + bevacizumab + chemotherapy in the initial diagnosis of stage III or IV ovarian cancer: a placebo-controlled randomized phase III study (IMagyn050/GOG ​​3015/ENGOT- OV39)

    • Last Update: 2021-06-16
    • Source: Internet
    • Author: User
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    Ovarian cancer (OC) is a common malignant tumor in women
    .


    The standard treatment is generally surgery combined with platinum-taxane chemotherapy


    Ovarian cancer (OC) is a common malignant tumor in women


    The study is a multi-center, placebo-controlled, double-blind, randomized controlled phase III clinical study
    .


    The dual study endpoints are PFS and OS, and the secondary endpoints are objective response rate (ORR), duration of response (DoR) and adverse events (AE)


    The study is a multi-center, placebo-controlled, double-blind, randomized controlled phase III clinical study


    research summary

     research summary

    In an intent-to-population (ITT) analysis, the median PFS of the atilizumab group and the placebo group were 19.
    5 months (95% CI, 18.
    1 to 20.
    8) and 18.
    4 months (95% CI, 17.
    2 to 19.
    8), respectively (HR=0.
    92, 95% CI, 0.
    79 to 1.
    07, P=0.
    28)
    .


    In the analysis of PD-L1 positive patients, the median PFS of the atilizumab group and the placebo group were 20.


    In an intent-to-population (ITT) analysis, the median PFS of the atilizumab group and the placebo group were 19.


               ITT population and PD-L1 positive population PFS

    ITT population and PD-L1 positive population PFS

    At the time of PFS analysis, the median OS was not yet mature
    .


    In an intent-to-population (ITT) analysis, the 2-year OS rates for the atilizumab group and placebo group were 81% (95% CI, 77 to 84) and 79% (95% CI, 75 to 83), respectively


    At the time of PFS analysis, the median OS was not yet mature


                 ITT population and PD-L1 positive population OS

    ITT population and PD-L1 positive population OS

    In the Intentional Population (ITT), 233 of the 251 evaluable patients in the atelizumab group experienced remission (93%; 95% CI, 89 to 96), while 239 evaluable patients in the placebo group Remission occurred in 212 patients (89%; 95% CI, 84 to 92)
    .


    Among PD-L1 positive patients, 156 of the 169 evaluable patients in the atelizumab group experienced remission (92%; 95% CI, 87 to 96), while 158 of the 158 evaluable patients in the placebo group Remission occurred in 142 patients (90%; 95% CI, 84 to 94)


    In the Intentional Population (ITT), 233 of the 251 evaluable patients in the atelizumab group experienced remission (93%; 95% CI, 89 to 96), while 239 evaluable patients in the placebo group Remission occurred in 212 patients (89%; 95% CI, 84 to 92)


    Among patients with immune cell (ICs) PD-L1 expression greater than or equal to 5%, the median PFS of the atilizumab group and the placebo group were not reached and 20.


               IC and TC PFS with different expression levels of PDL1

    IC and TC PFS with different expression levels of PDL1

    The incidence of Grade 3/4 AEs in the atilizumab group and placebo group was 79% and 73%, respectively
    .
    The most common grade 3/4 AEs were neutropenia (21% in the atelizumab group and 21% in the placebo group), hypertension (18% v 20%, respectively) and anemia (12% v 12 %)
    .

    The incidence of Grade 3/4 AEs in the atilizumab group and placebo group was 79% and 73%, respectively
    .
    The most common grade 3/4 AEs were neutropenia (21% in the atelizumab group and 21% in the placebo group), hypertension (18% v 20%, respectively) and anemia (12% v 12 %)
    .

    In summary, the existing evidence does not support the addition of Atezolizumab to the standard treatment for initial diagnosis of FIGO III or IV ovarian cancer
    .

    In summary, the existing evidence does not support the addition of Atezolizumab to the standard treatment for initial diagnosis of FIGO III or IV ovarian cancer
    .
    Existing evidence does not support the addition of Atezolizumab to the standard treatment for initial diagnosis of FIGO III or IV ovarian cancer
    .
    Existing evidence does not support the addition of Atezolizumab to the standard treatment for initial diagnosis of FIGO III or IV ovarian cancer
    .
    diagnosis

    Original source:

    Original source:

    Kathleen N Moore, Michael Bookman, Jalid Sehouli, et al.
    Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG ​​3015/ENGOT-OV39).
    J Clin Oncol .
    2021 Jun 10;39(17):1842-1855.
    doi: 10.
    1200/JCO.
    21.
    00306.
    Epub 2021 Apr 23.

    Kathleen N Moore, Michael Bookman, Jalid Sehouli, et al.
    Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG ​​3015/ENGOT-OV39).
    J Clin Oncol .
    2021 Jun 10;39(17):1842-1855.
    doi: 10.
    1200/JCO.
    21.
    00306.
    Epub 2021 Apr 23.
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