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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (HER2-targeted antibody-drug conjugate, Topoisomerase I inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors
Excerpt:
...ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Source:
Title:
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Excerpt:
...- Has a pathologically documented unresectable or metastatic gastric or GEJ adenocarcinoma, or breast cancer, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +] that is refractory to or intolerable with standard treatment, or for which...
Trial ID:
Source:
Title:
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Excerpt:
...Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)`The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. ...
Trial ID:
Less C2 evidence
Source:
Title:
O-11 Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma: A randomized, phase 2, multicenter, open-label study (DESTINY-Gastric01)
Published date:
07/08/2020
Excerpt:
OS was significantly prolonged with T-DXd (median OS, 12.5 vs 8.4 months; HR, 0.59 [95% CI, 0.39-0.88]; P =.0097;...T-DXd demonstrated statistically significant and clinically meaningful improvements in ORR and OS compared with standard chemotherapy (paclitaxel or irinotecan) in patients with HER2+ advanced gastric or GEJ adenocarcinoma.
DOI:
https://doi.org/10.1016/j.annonc.2020.04.064
Trial ID:
Source:
Title:
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study
Published date:
04/29/2019
Excerpt:
Between Aug 28, 2015, and Aug 10, 2018, 44 patients with HER2-positive gastric or gastro-oesophageal junction cancer received at least one dose of trastuzumab deruxtecan at the recommended doses for expansion...19 (43·2%; 95% CI 28·3-59·0) of 44 patients had a confirmed objective response...Trastuzumab deruxtecan had a manageable safety profile and showed preliminary activity in heavily pretreated patients with HER2-positive gastric or gastro-oesophageal junction cancer.
DOI:
10.1016/S1470-2045(19)30088-9
Trial ID:
