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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Urothelial Cancer |
| Drug: | Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer
Published date:
09/25/2020
Excerpt:
RemeGen Co., Ltd. (“RemeGen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer (UC) who have also previously received platinum-containing chemotherapy treatment.
Source:
Title:
A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
Excerpt:
...- HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests...
Trial ID:
Source:
Title:
Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2–Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials
Published date:
11/21/2023
Excerpt:
DV demonstrated a promising efficacy with a manageable safety profile in patients with HER2-positive locally advanced or metastatic UC who had progressed on at least one line of systemic chemotherapy.
DOI:
10.1200/JCO.22.02912
Source:
Title:
RC48-ADC for metastatic urothelial carcinoma with HER2-positive: Combined analysis of RC48-C005 and RC48-C009 trials.
Published date:
05/26/2022
Excerpt:
DCR was 82.2% (95% CI:73.7%, 89.0%). The mPFS was 5.9 (95% CI:4.2, 7.2) months. The mOS was 14.2 (95% CI:9.7, 18.8) months. The median OS follow up time was 19.1 months….RC48-ADC showed continuously a promising efficacy with a manageable safety profile in HER2-postive mUC patients who had failed at least one line systemic chemotherapy.
DOI:
10.1200/JCO.2022.40.16_suppl.4520
Source:
Title:
A phase II study of RC48-ADC in HER2-positive patients with locally advanced or metastatic urothelial carcinoma.
Excerpt:
RC48-ADC has demonstrated a clinically meaningful ORR of 60.5% in pretreated HER-2 positive mUC patients including those who underwent failure to the immunotherapy.
DOI:
10.1200/JCO.2019.37.15_suppl.4509
Trial ID:
