Trastuzumab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase II for Triple-Negative Breast Cancer (TNBC). According to GlobalData, Phase II drugs for Triple-Negative Breast Cancer (TNBC) have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Trastuzumab deruxtecan’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Trastuzumab deruxtecan overview

Trastuzumab deruxtecan (Enhertu, Detrastuzumab) 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 recurrent glioblastoma, osteosarcoma, gallbladder cancer, leptomeningeal carcinoma, 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.

For a complete picture of Trastuzumab deruxtecan’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.