Trastuzumab duocarmazine is under clinical development by Byondis and currently in the Phase I, Phase II and Pre-Registration 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 duocarmazine’s likelihood of approval (LoA) and phase transition for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) took place on 27 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 duocarmazine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Trastuzumab duocarmazine LOA Data

Report Segments
  • Innovator
Drug Name
  • Trastuzumab duocarmazine
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Pre-Registration

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.