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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Enhertu (fam-trastuzumab deruxtecan-nxki) (Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
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
Published date:
04/05/2024
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:
ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors
Published date:
01/29/2024
Excerpt:
...ENHERTU® (famtrastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive immunohistochemistry [IHC] 3+) solid tumors...
Source:
Title:
ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers
Published date:
08/31/2023
Excerpt:
ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens.
Source:
Title:
Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy
Excerpt:
...- Subjects must have confirmed, per local testing on most recent tumor tissue sample available, an HER2-positive expression, as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Excerpt:
...Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer`Objective response rate (defined as CR+PR) was reported based on independent central review. ...
Trial ID:
More C2 evidence
Source:
Title:
Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer
Excerpt:
...- Patients must have HER2-positive or HER2-expressing tumors as defined by Clinical Laboratory Improvement Act (CLIA)-certified labs....
Trial ID:
Source:
Title:
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Excerpt:
...- Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, or for which...
Trial ID:
Source:
Title:
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Excerpt:
...has HER2 positive expression confirmed per protocol...
Trial ID:
Source:
Title:
DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Excerpt:
...HER2-low expressing status...
Trial ID:
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:
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Excerpt:
...- Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 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:
Source:
Title:
Phase 2, Open label Study of DS-8201a, an Anti-HER2-AntIbody Drug Conjugate (ADC) for advanced BreaSt Cancer patients, with biomarkers analysis to characterize response/resistance to therapY
Excerpt:
...Additionally: • Patient with HER2 over-expressing (IHC3+ and IHC2+/ISH+) tumor must have been treated and have progressed on trastuzumab and on TDM-1. ...
Trial ID:
Source:
Title:
A study to investigate the efficacy and safety of trastuzumab deruxtecan in patients With or Without Brain Metastasis Who Have Previously-Treated Advanced or Metastatic HER2 Positive Breast Cancer
Excerpt:
...Pathologically documented breast cancer that: (a) Is unresectable/advanced or metastatic, and (b) Has confirmed HER2+ expression 2. ...
Trial ID:
Source:
Title:
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
Excerpt:
...has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma
Excerpt:
......
Trial ID:
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 HER2-expressing locally advanced/metastatic breast cancer, and HER2-expressing or HER2-mutant locally advanced/metastatic NSCLC...
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Excerpt:
...o Has a history of Her2 expression or activating Her2-mutation...
Trial ID:
Source:
Title:
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Excerpt:
...has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3....
Trial ID:
Source:
Title:
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Excerpt:
...Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) 3....
Trial ID:
Source:
Title:
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Excerpt:
...has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology...
Trial ID:
Source:
Title:
DESTINY Breast Respond HER2-low Europe
Excerpt:
...Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer...
Trial ID:
Source:
Title:
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Excerpt:
...unresectable/advanced or metastatic; confirmed HER2-positive status expression as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines -...
Trial ID:
Source:
Title:
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Excerpt:
...- HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization....
Trial ID:
Less C2 evidence
Source:
Title:
74MO - Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: Primary analysis from the DESTINY-PanTumor02 (DP-02) study
Published date:
11/27/2023
Excerpt:
In all pts, investigator-assessed ORR (95% CI) was 37.1% (31.3, 43.2); mDOR (95% CI) was 11.3 mo (9.6, 17.8); mPFS (95% CI) was 6.9 mo (5.6, 8.0); and mOS (95% CI) was 13.4 mo (11.9, 15.5). In pts with IHC 3+ expression (central; n=75) ORR was 61.3% (49.4, 72.4); mDOR was 22.1 mo (9.6, not reached); mPFS was 11.9 mo (8.2, 13.0); and mOS was 21.1 mo (15.3, 29.6)....We observed durable responses to T-DXd and clinically meaningful PFS and OS in pretreated pts across HER2-expressing tumors, with safety consistent with the known profile. These data support T-DXd as a potential tumor-agnostic treatment in HER2-expressing tumors.
Trial ID:
Source:
Title:
Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial
Published date:
10/23/2023
Excerpt:
Our study demonstrates durable clinical benefit, meaningful survival outcomes, and safety consistent with the known profile (including ILD) in pre-treated patients with HER2-expressing tumors receiving T-DXd. Greatest benefit was observed for the IHC 3+ population. These data support the potential role of T-DXd as a tumor-agnostic therapy for patients with HER2-expressing solid tumors.
DOI:
10.1200/JCO.23.02005
Source:
Title:
ENHERTU® Demonstrated Clinically Meaningful Progression-Free Survival and Overall Survival Across Multiple HER2 Expressing Advanced Solid Tumors in DESTINY-PanTumor02 Phase 2 Trial
Published date:
07/27/2023
Excerpt:
Topline results from the primary analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2 expressing advanced solid tumors, two secondary endpoints of the trial.
Trial ID:
Source:
Title:
Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) interim results.
Published date:
06/07/2023
Excerpt:
In all 267 pts, the ORR was 37.1% and median DOR (mDOR) was 11.8 mo; in pts with IHC 3+ expression, the ORR was 61.3% and mDOR was 22.1 mo. ORR per cohort is shown in all pts and those with centrally confirmed HER2 IHC 3+ or IHC 2+ expression….This is the first tumor-agnostic global study of T-DXd in a broad range of HER2-expressing solid tumors. T-DXd showed encouraging ORR, particularly in pts with IHC 3+ expression, durable clinical benefit, and a manageable safety profile in this heavily pretreated population. These interim results show T-DXd to be a potential new Tx option for pts with HER2-expressing solid tumors.
DOI:
10.1200/JCO.2023.41.17_suppl.LBA3000
Trial ID:
Source:
Title:
The efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-expressing solid tumours: a single-arm meta-analysis
Published date:
04/27/2023
Excerpt:
There were 11 studies including 1349 HER2-expressing patients in this meta-analysis. The pooled ORR was 47.91%, and the pooled DCR was 87.01%. The mPFS and mOS combined were 9.63 and 10.71 months, respectively....Overall, the efficacy of T-DXd in treating HER2-expressing solid tumours is encouraging...
DOI:
10.1093/jjco/hyad036
Source:
Title:
ENHERTU® Showed Clinically Meaningful and Durable Responses Across Multiple HER2 Expressing Tumor Types in DESTINYPanTumor02 Phase 2 Trial
Published date:
03/06/2023
Excerpt:
Positive topline results from an analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed treatment with Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) met the pre-specified target for objective response rate (ORR) and demonstrated durable response across multiple HER2 expressing advanced solid tumors in heavily pretreated patients.
Trial ID:
Source:
Title:
Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts.
Published date:
05/16/2018
Excerpt:
...enrolls subjects (sbj) with HER2+ breast cancer (BC) post T-DM1, HER2+ gastric cancer (GC) post trastuzumab, HER2 low BC (IHC 1+ or 2+, ISH-), and other HER2-expressing solid tumors (IHC ≥1+)….Overall, RECIST-confirmed overall response rate (ORR) in the evaluable sbj was 81/160 (50.6%) with the highest ORR in HER2+ BC (64.2%)....DS-8201a shows antitumor activity in multiple tumor types with high ORR and durable responses in heavily pretreated sbj.
DOI:
10.1200/JCO.2018.36.15_suppl.2501
Trial ID:
