Tucatinib is under clinical development by Pfizer and currently in Phase III for Metastatic Breast Cancer. According to GlobalData, Phase III drugs for Metastatic Breast Cancer have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tucatinib’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.

Tucatinib overview

Tucatinib (Tukysa) is a potent antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Tukysa is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Tukysa in combination with trastuzumab and capecitabine is indicated  for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

Tucatinib (Irbinitinib, ONT380, ARRY380) is under development for the treatment of cervical cancer, uterine cancer, biliary tract cancer, HER2+ advanced solid tumors including gastric cancer, gastroesophageal junction adenocarcinoma, colorectal cancer, urothelial cancer, non-squamous non-small cell lung cancer, leptomeningeal metastases in HER2 positive breast cancer, metastatic breast cancer as first-line therapy or second-line therapy and with or without brain metastases, metastatic colorectal cancer, esophageal cancer, cholangiocarcinoma, gastric adenocarcinoma, gallbladder carcinoma, bladder cancer, endometrial cancer, brain cancer and adenocarcinoma of the gastroesophageal junction. The drug candidate is administered through the oral route. ONT380 is a small molecule that acts by targeting ErbB-2 (human epidermal growth factor receptor 2).

Pfizer overview

Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, women’s health, cancer, inflammation, immune disorders, and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, individual provider offices, clinics, government agencies, and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East. Pfizer is headquartered in New York, the US.

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

This content was updated on 10 June 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.