Trastuzumab duocarmazine is under clinical development by Byondis and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 49% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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 negative low expressing breast 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.

It was under development for urothelial cancer, gastric cancer and human epidermal growth factor receptor 2 positive breast cancer (HER2+ Breast Cancer).

Byondis overview

Byondis, discovers and develops innovative precision medicines for the treatment of auto-immune diseases including cancer. The company’s pipeline includes trastuzumab, SYD985, BYON3521, BYON4228 and BYON4413. Its pipeline candidates treat breast and gastric cancer and endometrial cancer. 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 tumors 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.

This content was updated on 20 February 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.