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    Home > Biochemistry News > Biotechnology News > First-line treatment of lung cancer Junshi PD-1 antibody combination reaches phase 3 clinical endpoint

    First-line treatment of lung cancer Junshi PD-1 antibody combination reaches phase 3 clinical endpoint

    • Last Update: 2021-09-04
    • Source: Internet
    • Author: User
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    On August 18, 2021, Junshi Biosciences and Coherus Biosciences jointly announced that the pivotal phase 3 clinical trial named "CHOICE-01" has achieved positive interim results
    .


    The trial aims to evaluate the efficacy of toripalimab combined with chemotherapy drugs developed by Junshi Biotechnology in the first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC)


    Teriprolizumab is a recombinant humanized anti-PD-1 monoclonal antibody
    .


    PD-1 is an immune checkpoint receptor on the surface of lymphocytes.


    The randomized, double-blind, placebo-controlled phase 3 clinical trial of CHOICE-01 enrolled 465 patients with newly treated advanced squamous (n=220) or non-squamous (n=245) NSCLC
    .

    The main interim analysis results of the trial are as follows:

    Compared with the placebo group, the teriprolizumab group showed a clinically significant and statistically significant improvement in PFS [HR=0.
    58, (95% CI: 0.
    44-0.
    77), P=0.
    0001], the median PFS was 8.
    3 vs.
    5.
    6 months
    .


    The 1-year PFS rates of the teriprizumab group and the placebo group were 32.


    Regardless of whether the tumor cells express PD-L1, improvement of PFS was observed in both squamous [HR=0.
    55 (95% CI: 0.
    38-0.
    83)] and non-squamous [HR=0.
    59 (95% CI: 0.
    40-0.
    87)] NSCLC patients
    .

    Compared with the placebo group, the teriplimumab group showed an improved objective response rate (ORR) (squamous NSCLC: 68.
    7% vs.
    58.
    9%; non-squamous NSCLC: 58.
    6% vs.
    26.
    5%) and a median response rate Duration (DoR) (squamous NSCLC: 6.
    9 months vs.
    4.
    2 months; non-squamous NSCLC: 8.
    6 months vs.
    5.
    1 months)
    .

    The overall survival data is not yet mature, but there is a trend to support the teriplimumab group.
    Compared with the placebo group (16 months), the median overall survival (OS) is 21.
    0 months [HR=0.
    81 (95 % CI: 0.
    57-1.
    17)]
    .

    In terms of safety, teriprizumab combined with standard chemotherapy in the first-line treatment of patients with advanced NSCLC showed manageable safety characteristics, and no new safety signals were observed
    .


    The incidence of grade ≥3 adverse events (AE) in the teriprizumab group and placebo group was 76.


    Reference materials:

    [1] Junshi and Coherus Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Teriplimumab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer.


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