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    Association details:
    Biomarker:CLDN18.2 expression
    Cancer:Esophageal Adenocarcinoma
    Drug:Vyloy (zolbetuximab) (CLDN18.2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

    Excerpt:
    ...- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample....
    Trial ID:
    NCT01671774
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

    Excerpt:
    ...- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample....
    Trial ID:
    FAST
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ann Oncol
    Title:

    FAST: A randomised phase II study of zolbetuximab (IMAB362) plus EOX vs EOX alone for first-line treatment of advanced CLDN18.2 positive gastric and gastro-oesophageal adenocarcinoma

    Published date:
    02/18/2021
    Excerpt:
    The FAST study enrolled advanced gastric/gastro-oesophageal junction (G/GEJ) and oesophageal adenocarcinoma (EC) patients (≥18 years) with moderate-to-strong CLDN18.2 expression in ≥40% tumour cells….zolbetuximab+EOX...In the overall population, both PFS (HR=0.44; 95% CI, 0.29–0.67; P<0.0005) and OS (HR=0.55; 95% CI, 0.39–0.77; P<0.0005) were significantly improved with zolbetuximab+EOX (Arm 2) compared with EOX alone (Arm 1).
    Secondary therapy:
    EOX
    DOI:
    10.1016/j.annonc.2021.02.005