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Association details:
| Biomarker: | ERBB3 expression |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | patritumab deruxtecan (U3-1402) (Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Excerpt:
Documented HER3-positive disease measured by immunohistochemistry (IHC)...
Trial ID:
Source:
Title:
Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3–Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3–Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial
Published date:
10/06/2023
Excerpt:
Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody-drug conjugate that is being evaluated as a novel treatment in HER3-expressing advanced breast cancer in the U31402-A-J101 study....Objective responses were observed in cancers with HER3-high and HER3-low membrane expression….HER3-DXd demonstrated a manageable safety profile and durable efficacy in heavily pretreated patients across clinical subtypes.
DOI:
10.1200/JCO.23.00882
Trial ID:
Source:
Title:
A phase 2 study of HER3-DXd in patients (pts) with metastatic breast cancer (MBC).
Published date:
05/25/2023
Excerpt:
This 3-part Phase 2 study examines efficacy of HER3-DXd across MBC subsets and defines the pt population likely to derive greater benefit...Pts with ≥75% HER3 expression had an ORR of 33% and CBR of 50%, pts with HER3 25-74% expression had an ORR of 46% and CBR of 54%....HER3-DXd had an acceptable safety profile, and the data further confirm the clinical activity in MBC in heavy pre-tx MBC across the broad range of HER3 expression levels.
DOI:
10.1200/JCO.2023.41.16_suppl.1004
Trial ID:
Source:
Title:
Single agent activity of U3-1402, a HER3-targeting antibody-drug conjugate, in breast cancer patients: Phase 1 dose escalation study.
Published date:
05/16/2018
Excerpt:
In a preliminary analysis of 21 pts, U3-1402 exhibits antitumor activity in previously treated HER3 expressing MBC pts and treatment is associated with a manageable safety profile.
DOI:
10.1200/JCO.2018.36.15_suppl.2512
Trial ID:
Source:
Title:
/ 26 - HER3-targeting antibody-drug conjugate, U3-1402, induces tumor regression in a variety of xenograft models and exerts enhanced antitumor activity by combining with PI3K inhibition
Published date:
05/15/2020
Excerpt:
Antitumor activity of U3-1402 was assessed in various xenograft models of human cancers, including breast, lung, and colorectal cancers, and melanoma....U3-1402 may exert potent antitumor activity in various human cancer cells expressing HER3, and its efficacy is likely to be enriched by HER3 expression.
