Also known as: DS-8201a, Trastuzumab Pamirtecan
Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki) is marketed as ENHERTU, a HER2-directed antibody and topoisomerase inhibitor conjugate used across multiple advanced HER2-expressing cancers. Labeling includes metastatic HER2-positive breast cancer settings, HER2-low/HER2-ultralow breast cancer, HER2-mutant NSCLC, HER2-positive gastric/GEJ adenocarcinoma, and HER2-positive solid tumors under accelerated approval. U.S. initial approval was in 2019.
New research highlights strategies to overcome cancer drug resistance: a triple-drug AML combination, a breast cancer resistance target, evolutionary treatment switching, DNA damage mechanisms, and sildenafil's anti-metastatic potential.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
At ASCO 2026, Rutgers and Ohio State researchers present new breast cancer combination data, lymphoma survival analyses, and a drug donation program that cut medication wait times to about six days.
Single-cell RNA sequencing of nearly 92,000 cells from the DESTINY-Gastric06 trial reveals distinct primary and acquired resistance mechanisms to trastuzumab deruxtecan in HER2-positive gastric cancer, including MUC3A and CST3 as key drivers.
BioNTech enters May with first-quarter earnings due May 5 and a May 15 shareholder vote on a capital increase. The company is pushing its oncology pipeline as COVID-19 vaccine sales decline.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07701941 |
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07683754 |
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd |
NOT_YET_RECRUITING | PHASE3 |
| NCT07619521 |
Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07619365 |
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07582887 |
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response |
RECRUITING | |
| NCT07578116 |
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07454668 |
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07428044 |
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07416253 |
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07393425 |
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer |
RECRUITING | PHASE2 |
