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    Home > Active Ingredient News > Blood System > STTT Nanjing Medical University Li Jianyong and Fan Lei found that Sintilimab can potentially treat relapsed/refractory extranodal NK/T cell lymphoma

    STTT Nanjing Medical University Li Jianyong and Fan Lei found that Sintilimab can potentially treat relapsed/refractory extranodal NK/T cell lymphoma

    • Last Update: 2021-11-15
    • Source: Internet
    • Author: User
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    Editor’s note iNature is China’s largest academic official account.
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    iNature extranodal natural killer (NK)/T-cell lymphoma (ENKTL) is a highly aggressive subtype of non-Hodgkin’s lymphoma (NHL) with a high incidence in Asia and Latin America
    .

    In China, ENKTL accounts for 6.
    6% of all NHL and 28.
    1% of peripheral T lymphoma (PTCL)
    .

    The 5-year overall survival (OS) of ENKTL patients is 40-50%
    .

    Due to the high expression of multidrug resistant P-glycoprotein, ENKTL does not respond well to traditional anthracycline chemotherapy
    .

    This study (ORIENT-4) aims to evaluate Sintilimab (Sintilimab, a humanized anti-PD-1 antibody) in patients with relapsed/refractory extranodal NK/T cell lymphoma (r/r ENKTL) In the efficacy and safety
    .

    On October 27, 2021, Li Jianyong and Fan Lei of Nanjing Medical University published an online newsletter titled "Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm" in Signal Transduction and Targeted Therapy (IF=18.
    19).
    , phase 2 trial (ORIENT-4)" research paper, this study is a multi-center, single-arm, phase 2 clinical trial (NCT03228836)
    .

    Patients with r/r ENKTL who failed at least one asparaginase-based treatment regimen were enrolled and received 200 mg Sintilizumab intravenously every 3 weeks for up to 24 months
    .

    The primary endpoint is the objective response rate (ORR) based on Lugano's 2014 criteria
    .

     28 r/r ENKTL patients were enrolled from August 31, 2017 to February 7, 2018
    .

    21 patients (75.
    0%, 95% CI: 55.
    1-89.
    3%) achieved objective remission
    .

    The median follow-up was 30.
    4 months, and the median overall survival (OS) was not reached
    .

    The 24-month OS rate was 78.
    6% (95% CI, 58.
    4-89.
    8%)
    .

    Most treatment-related adverse events (TRAE) were grade 1-2 (71.
    4%), and the most common TRAE was a decrease in lymphocyte count (42.
    9%)
    .

    Seven (25.
    0%) patients had serious adverse events (SAE), and no patients died of adverse events
    .

    Sintilimab is effective and well tolerated in patients with r/r ENKTL, and may become a new treatment method to control ENKTL in patients
    .

    Extranodal natural killer (NK)/T cell lymphoma (ENKTL) is a highly aggressive subtype of non-Hodgkin's lymphoma (NHL) with a high incidence in Asia and Latin America
    .

    In China, ENKTL accounts for 6.
    6% of all NHL and 28.
    1% of peripheral T lymphoma (PTCL)
    .

    The 5-year overall survival (OS) of ENKTL patients is 40-50%
    .

    Due to the high expression of multidrug resistant P-glycoprotein, ENKTL does not respond well to traditional anthracycline chemotherapy
    .

    The asparaginase-based regimen is effective for ENKTL, with an objective response rate (ORR) of 67–79% and a complete response rate (CR) of 45–61%
    .

    Patients who fail to treat asparaginase have a limited median survival time of <6 months
    .

    Epstein–Barr virus (EBV) infection is an important etiology and prognostic factor of ENKTL
    .

    Overexpression of PD-L1 induced by EBV infection is a potential mechanism for ENKTL to avoid immune surveillance.
    Anti-PD-1 antibody/refractory (r/r) ENKTL in patients with relapse has shown potential efficacy
    .

    Anti-PD-1 monoclonal antibody (mAb) can rescue T cell viability suppressed by EBV-positive diffuse large B-cell lymphoma
    .

    Two retrospective studies with limited sample sizes showed that pembrolizumab is active in r/r ENKTL, with ORRs of 100% (n = 7) and 57.
    1% (n = 7), respectively
    .

    Two case reports also demonstrated the efficacy of anti-PD-1 mAb in r/r ENKTL after asparaginase-based treatment
    .

    Recently, a study reported the effectiveness and safety of PD-L1 antibody-avelumab as a single-agent treatment of r/r ENKTL, showing an ORR of 38% and a CR rate of 24% in 21 patients
    .

    However, there is little clinical evidence regarding the anti-tumor activity of PD-1 inhibitors in ENKTL patients
    .

    Sintilimab (sintilimab) is a recombinant humanized anti-PD-1 mAb that can bind to human PD-1
    .

    According to preclinical data, compared with pembrolizumab or nivolumab, sintilimab has a different binding site and may have a higher affinity for PD-1
    .

    Sintilimab has proven to have clinical benefits in various cancers
    .

    This prospective phase 2 study aims to evaluate the efficacy and safety of sintilimab on r/r ENKTL
    .

    The study is a multi-center, single-arm, phase 2 clinical trial (NCT03228836)
    .

    Patients with r/r ENKTL who failed at least one asparaginase-based treatment regimen were enrolled and received 200 mg Sintilizumab intravenously every 3 weeks for up to 24 months
    .

    The primary endpoint is the objective response rate (ORR) based on Lugano's 2014 criteria
    .

     28 r/r ENKTL patients were enrolled from August 31, 2017 to February 7, 2018
    .

    21 patients (75.
    0%, 95% CI: 55.
    1-89.
    3%) achieved objective remission
    .

    The median follow-up was 30.
    4 months, and the median overall survival (OS) was not reached
    .

    The 24-month OS rate was 78.
    6% (95% CI, 58.
    4-89.
    8%)
    .

    Most treatment-related adverse events (TRAE) were grade 1-2 (71.
    4%), and the most common TRAE was a decrease in lymphocyte count (42.
    9%)
    .

    Seven (25.
    0%) patients had serious adverse events (SAE), and no patients died of adverse events
    .

    Sintilimab is effective and well tolerated in patients with r/r ENKTL, and may become a new treatment method to control ENKTL in patients
    .

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