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Association details:
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Solid Tumor)
New
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.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2)-expressing salivary duct carcinoma: Subgroup analysis of two phase 1 studies.

Published date:
05/19/2021
Excerpt:
At data cutoff (FIH study: 1 Aug 2019; DDI study: 26 Sep 2018), the confirmed overall response rate was 47% (8/17) and the best overall response was PR in 8 pts and SD in 9 pts. Median duration of response and progression-free survival were 12.9 months and 14.1 months...T-DXd showed promising antitumor activity in HER2-expressing salivary duct carcinoma with durable response.
DOI:
10.1200/JCO.2021.39.15_suppl.6079
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors

Published date:
03/25/2020
Excerpt:
In addition to NSCLC and colorectal cancer, responses were also observed across a number of other tumor types, including HER2-expressing or HER2-amplified salivary gland cancer, biliary tract cancer, and endometrial cancer, and HER2-mutant nonamplified breast cancer (Fig. 3). In this group, the ORR was 6 of 22 (27.3%) and the median DoR was not reached (95% CI, 3.0–not reached). The median PFS was 11.0 months (95% CI, 2.8–NE; Table 3).
DOI:
10.1158/2159-8290.CD-19-1014
Trial ID: