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

Trastuzumab duocarmazine (SYD-985) is under development for the treatment of metastatic solid tumor including HER2 low expressing breast cancer, urothelial cancer, gastric cancer, epithelial ovarian cancer and uterine serous carcinoma (USC) (endometrial cancer). The drug candidate is administered through intravenous route as a powdered solution. SYD-985 is a HER-2 targeting antibody-drug conjugate composed of trastuzumab linked to duocarmycin (cytotoxic agent). The therapeutic candidate is developed based on ADC platform and SpaceLink technology in which a monoclonal antibody is conjugated to potent toxins by chemical linkers.

Byondis overview

Byondis, formerly Synthon Biopharmaceuticals, focuses on the discovery and development of innovative precision medicines for the treatment of auto-immune diseases including cancer. The company offers biosimilar of trastuzumab, a monoclonal antibody indicated for the treatment of breast and stomach cancers. It is advancing its lead candidate: SYD985, a novel duocarmycin-based HER2-targeting antibody drug conjugate (ADC), and a portfolio of preclinical and clinical programs with an aim to provide novel treatments for solid tumours that overexpress HER2, uterine serous carcinoma and auto-immune diseases. It harnesses its proprietary linker-drug (LD) technology to generate ADCs targeting treatment for different indications. The company works in collaboration with pharmaceutical companies including Amgen, Allergan and Macrogenics; academic institutions; and medical communities worldwide. Byondis is headquartered in Nijmegen, Gelderland, the Netherlands.

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


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.