Zanidatamab zovodotin is under clinical development by Zymeworks and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Zanidatamab zovodotin’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.

Zanidatamab zovodotin overview

Zanidatamab Zovodotin is under development for the treatment of HER-2 positive breast cancer, brain metastases, endometrial cancer, gastroesophageal adenocarcinoma, gynecologic cancers, metastatic breast cancer, non-small cell lung cancer, anal cancer, and colorectal cancer. It is being administered through intravenous route. It comprises Azymetric biparatopic anti-HER2 antibody conjugated to proprietary cytotoxic payload (auristatin) via a cleavable linker. The drug candidate is an bi-specific antibody-drug conjugate (biparatopic antibody) targeting tumor cells expressing ECD4 and ECD2 epitopes of HER2. It is developed based on Azymetric and Zymelink technology platforms. These technologies enables the production of ADCs with target affinity, effector function and increase in circulation half life. ZW49 delivers a novel auristatin (cell-killing compound) to tumor cells by taking advantage of the enhanced antibody-HER2 internalization of zanidatamab.

Zymeworks overview

Zymeworks is a clinical-stage biopharmaceutical company that discovers, develops and commercializes biotherapeutics for the treatment of cancer, autoimmune and inflammatory diseases. The company’s lead product candidates are Zanidatamab for the treatment of biliary tract cancers, breast cancer, gastroesophageal adenocarcinomas and colorectal cancer, Zanidatamab Zovodotin for HER2-expressing cancers. Its other preclinical pipeline includes ZW191 – TOPO1i antibody-drug conjugate for ovarian and gynecological cancers and ZW171 for solid tumors. Zymeworks technology platform comprises Azymetric, Zymelink, Efect and Protect. It operates in the US and Canada. Zymeworks is headquartered in Vancouver, British Columbia, Canada.

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

This content was updated on 20 May 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.