Tucatinib is under clinical development by Seagen and currently in the Phase II, Phase III 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 Tucatinib’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 31 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Tucatinib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tucatinib overview

Tucatinib (Tukysa) is a potent antineoplastic agent. It is formulated as film coated tablets and 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, and 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 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).

Seagen overview

Seagen, formerly Seattle Genetics, is a biotechnology company that discovers, develops, and markets monoclonal antibody-based therapies for the treatment of cancer. It markets antibody-drug conjugates (ADCs), including Adcetris (brentuximab vedotin), for the treatment of Hodgkin’s lymphoma, T-cell lymphomas and CD30-expressing lymphomas; Padcevtm (enfortumab vedotin-ejfv) for metastatic urothelial cancers; Tukysa (tucatinib) for the treatment of metastatic HER2-positive breast cancers, and Tivdak (tisotumab vedotin-tftv) for the treatment of certain metastatic cervical cancers. The company’s pipeline consists of novel therapies for addressing the unmet medical needs of blood-related cancers and solid tumors. Seagen products and pipeline are based on ADC technology, which targets monoclonal antibodies and delivers agents for killing cancer cells. The company sells its products through specialty distributors. Seagen is headquartered in Bothell, Washington, the US.

Quick View Tucatinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tucatinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Seagen
  • Originator: Array BioPharma
Highest Development Stage
  • Marketed

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.