^
Association details:
| Biomarker: | HER-2 underexpression |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
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:
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Excerpt:
...- Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which...
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan in Anti–Human Epidermal Growth Factor Receptor 2 Treatment–Naive Patients With Human Epidermal Growth Factor Receptor 2–Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial
Published date:
11/15/2022
Excerpt:
The confirmed objective response rate was 26.3% (95% CI, 9.1 to 51.2) from five partial responses in cohort 1 and 9.5% (95% CI, 1.2 to 30.4) from two partial responses in cohort 2. Thirteen patients (68.4%) in cohort 1 and 12 (60.0%) in cohort 2 experienced reduced tumor size. The median overall survival was 7.8 months (95% CI, 4.7 to non evaluable) in cohort 1 and 8.5 months (95% CI, 4.3 to 10.9) in cohort 2; the median progression-free survival was 4.4 months (95% CI, 2.7 to 7.1) and 2.8 months (95% CI, 1.5 to 4.3), respectively...This study provides preliminary evidence that T-DXd has clinical activity in patients with heavily pretreated HER2-low gastric/GEJ adenocarcinoma.
DOI:
10.1200/JCO.22.00575
Trial ID:
Source:
Title:
1422MO - Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-low, advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Results of the exploratory cohorts in the phase II, multicenter, open-label DESTINY-Gastric01 study
Published date:
09/18/2020
Excerpt:
Pts with centrally confirmed HER2-low (IHC 2+/ISH− [cohort 1] or IHC 1+ [cohort 2] on archival tissue) that progressed on ≥ 2 prior lines of therapy were enrolled in Japan and Korea. Pts were excluded if they had prior HER2 therapy. The primary endpoint was ORR by independent central review...T-DXd showed preliminary evidence of clinical activity in pts with previously treated, HER2-low gastric or GEJ cancer. The safety profile was similar to that in the HER2+ primary cohort.
Trial ID:
