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Association details:
| Biomarker: | HER-2 underexpression |
|---|---|
| Cancer: | Hormone Receptor Positive Breast Cancer |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer
Published date:
02/13/2023
Excerpt:
Among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician’s choice group (hazard ratio for disease progression or death, 0.50; P<0.001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P=0.001)....In this trial involving patients with HER2-low metastatic breast cancer, trastuzumab deruxtecan resulted in significantly longer progression-free and overall survival than the physician’s choice of chemotherapy.
DOI:
10.1056/NEJMoa2203690
Trial ID:
Source:
Title:
ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Patients with HER2 Low Metastatic Breast Cancer
Published date:
04/26/2022
Excerpt:
Daiichi Sankyo (TSE: 4568) and AstraZeneca’s...ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy....The FDA granted the BTD based on data from the pivotal DESTINY-Breast04 phase 3 trial where ENHERTU demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer with HR positive or HR negative disease...
Title:
Enhertu approved in China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Excerpt:
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy....The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast04 Phase III trial...
Source:
Title:
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
Excerpt:
...Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay 2....
Trial ID:
Source:
Title:
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Excerpt:
...- Pathologically documented, locally advanced/metastatic breast cancer that has centrally determined HER2-low expression (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH-])...
Trial ID:
