Trastuzumab deruxtecan
- Generic Name
- Trastuzumab deruxtecan
- Brand Names
- Enhertu
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1826843-81-5
- Unique Ingredient Identifier
- 5384HK7574
- Background
Trastuzumab deruxtecan is a HER-2 directed antibody attached to a topoisomerase inhibitor that is approved for use in certain types of metastatic, unresectable breast cancer. It is classified as an antibody-drug conjugate. The cleavable peptide linker used to bind the antibody and drug in this product distinguishes it from other members of its class. Trastuz...
- Indication
In the US, trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. It...
- Associated Conditions
- Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Adenocarcinoma, Metastatic Breast Cancer, Metastatic Breast Cancer With HER2 Positive, Unresectable Breast Cancer, Locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Locally advanced HER2-positive Gastric Adenocarcinoma, Metastatic HER2 Mutant Non-small Cell Lung Cancer, Metastatic HER2-low Breast Cancer, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic HER2-positive Gastric Adenocarcinoma, Unresectable HER2 Mutant Non-small Cell Lung Cancer, Unresectable HER2-low Breast Cancer, Unresectable HER2/Neu-positive Breast Cancer
- Associated Therapies
- -
Datopotamab Deruxtecan Final Overall Survival Results Reported in Patients with Metastatic HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
Final overall survival results from TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in HR-positive, HER2-low or negative breast cancer patients, despite positive progression-free survival results. Safety profile remained consistent with no new concerns. Subsequent treatment options likely affected survival results.
Daiichi Sankyo launches first DTC ad for Enhertu, representing shift toward patient-centric
Daiichi Sankyo launches first DTC campaign for Enhertu, 'Not Today,' airing on Amazon Prime’s Thursday Night Football, aiming to educate patients about its expanded uses. The campaign, featuring a 90-second black-and-white ad, resonates with metastatic breast cancer patients by acknowledging their struggles. Enhertu, a metastatic breast cancer drug by Daiichi Sankyo and AstraZeneca, has seen label expansions and $2.57 billion in combined sales in 2023.
Enhertu Shows Promising Results in Treating HER2-Positive Metastatic Breast Cancer
Enhertu (trastuzumab deruxtecan) demonstrated significant overall and intracranial clinical activity, including prolonged PFS, in HER2-positive mBC patients with brain metastases in the DESTINY-Breast12 trial. The findings support Enhertu's potential as a second-line treatment, with a 12-month PFS rate of 61.6% and CNS PFS rate of 58.9% among patients with brain metastases.
ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial
Daiichi Sankyo and Merck's antibody-drug conjugate, patritumab deruxtecan, met Phase 3 trial goals, delaying EGFR-mutated non-small cell lung cancer progression better than chemotherapy. The drug uses an antibody to target tumor cells and release a toxic chemical. Daiichi has six ADCs using deruxtecan chemotherapy, including Enhertu, with sales of $1.8 billion in H1 2024. Merck's $22 billion deal with Daiichi aims to bolster its pipeline as Keytruda patents near expiration.
AstraZeneca's HIMALAYA phase III trial of Imfinzi plus Imjudo demonstrates OS in advanced
HIMALAYA trial results show AstraZeneca’s Imfinzi plus Imjudo reduced HCC death risk by 24% at 5 years, with 19.6% survival vs 9.4% with sorafenib.
IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated unprecedented ...
The STRIDE regimen's safety profile aligns with known medicine profiles, with no new safety signals. IMFINZI and IMJUDO are approved for advanced or unresectable HCC in multiple countries. Immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, and endocrinopathies, are noted, necessitating close monitoring and prompt management. Infusion-related reactions and complications post-HSCT are also highlighted. IMFINZI and IMJUDO are not recommended for pregnant or breastfeeding women.
Imfinzi plus Imjudo demonstrated unprecedented overall survival in advanced liver cancer
HIMALAYA Phase III trial showed Imfinzi plus Imjudo significantly improved 5-year survival in advanced liver cancer, with 19.6% of patients alive vs. 9.4% on sorafenib.
T-DXd Maintains QOL, Delays Pain Deterioration in HR+/HER2-Low/Ultralow MBC
Trastuzumab deruxtecan (T-DXd) improved physical/role functioning and pain in HR+, HER2-low/-ultralow metastatic breast cancer patients compared to treatment of physician’s choice (TPC), with significant reductions in pain deterioration (22.0 months vs 6.3 months) and other symptoms, while maintaining global health/QOL over 31 weeks.
Enhertu to eclipse SOC for HER2+ breast cancer with brain metastases
Enhertu demonstrated superior efficacy in treating HER2+ breast cancer brain metastases at ESMO 2024, outperforming Kadcyla. Enhertu's 12-month PFS was 61.6% with an ORR of 79% for CNS metastases, maintaining 90.3% OS in active BCBM patients. Analysts predict Enhertu will dominate the ADC market, reaching $11.2bn by 2030, while Kadcyla and Tukysa are projected to achieve $838m and $1.2bn respectively.
First-Line T-DXd Combinations Show Early Antitumor Activity in HER2+ Gastric/GEJ Cancers
T-DXd, with or without pembrolizumab and fluoropyrimidine, showed antitumor activity and manageable safety in HER2-positive esophageal, gastric, and GEJ cancer patients. Full-dose T-DXd and fluoropyrimidine had the highest ORR (78%), while pembrolizumab-containing arms showed higher toxicities. Reduced-dose triplets demonstrated manageable safety.
Drug Development Updates
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