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Association details:
| Biomarker: | HER-2 mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Title:
Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Excerpt:
AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
Source:
Title:
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Excerpt:
...Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which...
Trial ID:
Source:
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).
Trial ID:
