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    Association details:
    Biomarker:HER-2 positive
    Cancer:Gastroesophageal Junction Adenocarcinoma
    Drug:anvatabart opadotin (JNJ-0683) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cell Reports Medicine
    Title:

    Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma

    Published date:
    11/15/2022
    Excerpt:
    The confirmed objective response rate is 37.9% (95% confidence interval [CI]: 20.7%-57.7%) and the disease control rate is 55.2% (95% CI: 35.7%-73.6%). With a median follow up of 10 months, the median progression-free survival and overall survival are 4.1 (95% CI: 1.4-6.4) and 10.7 months (95% CI: 4.8-not reached), respectively. The median duration of response is 8.4 (95% CI: 2.1-18.9) months. ARX788 is well tolerated and has promising anti-tumor activity in patients with HER2-positive advanced gastric adenocarcinoma.
    DOI:
    10.1016/j.xcrm.2022.100814
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ambrx Press Release
    Title:

    Ambrx Announces Positive Data on ARX788 for the Treatment of HER2+ Gastric Cancer Presented at CSCO

    Published date:
    10/04/2021
    Excerpt:
    Ambrx...today announced that NovoCodex Pharmaceuticals Ltd. (NovoCodex), Ambrx’s partner in China, presented positive interim data from the ACE-Gastric-01 Phase 1 clinical study of ARX788 for the treatment of HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer at The Chinese Society of Clinical Oncology (CSCO)...Demonstrated overall response rate (ORR) of 44.4% (12/27) in the response-evaluable patients across all three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks).Low drug-related severe adverse events (SAE) occurred in 6.7% (2/30) of all treated patients across all three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks). Drug-related grade 3 and above adverse events (AEs) comprised only 10% (3/30).
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    A phase 1 multicenter, dose expansion study of ARX788 as monotherapy in patients with HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma (ACE-Gastric-01).

    Published date:
    05/19/2021
    Excerpt:
    ARX788 was well tolerated with promising antitumor activity in patients with HER2-positive advanced gastric and GEJ adenocarcinoma.