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    Association details:
    Biomarker:HER-2 expression
    Cancer:Bladder Cancer
    Drug:Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

    Excerpt:
    ...- HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab....
    Trial ID:
    NCT05297552
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer

    Excerpt:
    ...- Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory....
    Trial ID:
    NCT05996952
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma

    Excerpt:
    ...Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function [glomerular filtration rate (GFR) 30-60mL/min], which is...
    Trial ID:
    NCT05723991
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    An Exploratory Clinical Study of Neoadjuvant Disitamab Vedotin Therapy for Muscler-Invasive Urothelial Bladder Cancer with HER2 Overexpression

    Excerpt:
    ...Histopathologically confirmed urothelial carcinoma of the bladder, mixed carcinoma requiring the urothelial carcinoma subtype as the predominant histological type, with immunohistochemical HER2 expression of 2+ or above; 6. ...
    Trial ID:
    ChiCTR2300068270
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Evaluating the Safety and Tolerability of Intravesical Instillation of Disitamab Vedotin (DV; RC48-ADC) for the Treatment of HER2-Expressing Non-Muscle Invasive Bladder Cancer (NMIBC) in High-Risk Bacillus Calmette-Guérin (BCG)-Naive or BCG-Non-Responsive Patients: An Open-Label, Single-Arm, Single-Center Clinical Trial.

    Excerpt:
    ...Tumor tissue samples obtained from the subject via TURBT within 3 weeks should demonstrate HER2 expression of 1+, 2+, or 3+ upon immunohistochemistry (IHC) testing. ...
    Trial ID:
    ChiCTR2300073975
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Front Pharmacol
    Title:

    Disitamab vedotin in combination with immune checkpoint inhibitors for locally and locally advanced bladder urothelial carcinoma: a two-center's real-world study

    Published date:
    08/30/2023
    Excerpt:
    The combination of DV and PD-1 demonstrated considerable activity in the objective response rate (ORR) in patients with HER2 IHC 0/1+/2+/3+ muscle-invasive bladder cancer (MIBC), along with the longest reported median radiological progression-free survival (rPFS) to date.
    Secondary therapy:
    PD-L1 inhibitor
    DOI:
    10.3389/fphar.2023.1230395