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

    A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

    Excerpt:
    ...- Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing....
    Trial ID:
    Spotlight
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

    Excerpt:
    ...- Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing....
    Trial ID:
    GLOW
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma

    Excerpt:
    ...- Subject's tumor is positive for CLDN18.2 expression....
    Trial ID:
    ILUSTRO
    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
    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
    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