Datopotamab deruxtecan is under clinical development by Daiichi Sankyo and currently in Pre-Registration for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Pre-Registration drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Datopotamab 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.

Datopotamab deruxtecan overview

DS-1062 is under development for the treatment of advanced solid tumors including metastatic hormone refractory (castration resistant, androgen-Independent) prostate cancer, cervical cancer, peritoneal cancer, fallopian tube cancer, epithelial ovarian cancer, metastatic ovarian cancer, metastatic biliary tract cancer; bladder cancer, squamous and non-squamous NSCLC, metastatic colorectal cancer, transitional cell carcinoma, metastatic transitional (urothelial) tract cancer, transitional cell cancer (urothelial cell cancer, biliary tract cancer, transitional cell cancer (urothelial cell cancer, head and neck cancer squamous cell carcinoma, esophageal cancer, metastatic adenocarcinoma of the pancreas, endometrial cancer, small-cell lung cancer, HR+, HER2- breast cancer, HER2 positive breast cancer, metastatic triple negative breast cancer, non muscle invasive bladder cancer and non small cell lung cancer. It is administered through intravenous route as a solution. The drug candidate is a TROP2-directed ADC consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to a highly potent topoisomerase l inhibitor payload. It targets Trop 2 protein. The therapeutic candidate is being developed based on antibody drug conjugate (ADC) DXd-ADC platform technology.

It was also under development for the treatment of pancreatic cancer.

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 Datopotamab deruxtecan’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 2024

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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 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.