Trastuzumab deruxtecan is under clinical development by Daiichi Sankyo and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Trastuzumab deruxtecan’s likelihood of approval (LoA) and phase transition for Metastatic Breast Cancer took place on 19 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Trastuzumab deruxtecan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Trastuzumab deruxtecan overview

Trastuzumab deruxtecan (Enhertu) composed of a protease-cleavable maleimide tetrapeptide and  topoisomerase which is an exatecan derivative, produced in Chinese hamster ovary cells by recombinant DNA technology, that acts as an anti neoplastic agent. It is formulated as powder for solution for intravenous route of administration. Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and also for treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu 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. Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. 

Trastuzumab deruxtecan (DS-8201) is under development for the treatment of osteosarcoma, gallbladder cancer, leptomeningeal carcinoma, refractory solid tumors including, metastatic or recurrent uterine carcinosarcoma, gastric cancer, non-squamous non-small cell lung cancer, metastatic biliary tract cancer, cervical cancer, endometrial cancer, epithelial ovarian cancer, metastatic pancreatic cancer, metastatic colorectal cancer, salivary gland cancer, Paget’s disease, cholangiocarcinoma, esophageal cancer, gastroesophageal junction adenocarcinoma, metastatic colorectal cancer, urothelial cancer, HR positive, HER2 low expressing and triple-negative breast cancer. The drug candidate is administered through intravenous route as a solution. The drug candidate is comprised of a humanized anti-HER2 antibody attached by a peptide linker to a derivative of the camptothecin analog exatecan and DNA topoisomerase 1 inhibitor (DXd) as payload. It is developed based on proprietary payload and linker-payload technology. It acts by targeting human epidermal growth factor receptor 2 (Her-2). It was also under development for osteosarcoma.

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies, and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

Quick View Trastuzumab deruxtecan LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Trastuzumab deruxtecan
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Musculoskeletal Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.