Guardant Health, Inc. (NASDAQ:GH) said real-world evidence generated through its InfinityAI platform helped support the recent approval of ENHERTU® (trastuzumab deruxtecan) in Japan for patients with previously treated HER2-positive metastatic solid tumors.
Japan’s Ministry of Health, Labour and Welfare (MHLW) granted the approval for ENHERTU, which is developed and commercialized by Daiichi Sankyo (TSE:4568), for patients with advanced or recurrent HER2-positive cancers — defined as HER2 (ERBB2) gene amplification or immunohistochemistry (IHC) 3+ — who are refractory or intolerant to standard treatments.
The regulatory decision was supported by results from multiple clinical trials, including HERALD, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01, along with supplemental real-world evidence generated using InfinityAI, Guardant Health’s artificial intelligence platform for analyzing clinical and molecular datasets.
HER2 amplification is well established in breast cancer, but identifying eligible patients and building evidence in other tumor types remains challenging, particularly in biomarker-defined populations with relatively low prevalence. In these settings, real-world data can help identify patients at scale and better characterize unmet medical need.
For the Japanese regulatory submission, Daiichi Sankyo incorporated real-world evidence derived from InfinityAI alongside clinical trial results. Guardant Health and Daiichi Sankyo jointly analyzed outcomes from a large cohort of patients whose HER2 amplifications were identified using Guardant360®, showing significant unmet need and real-world clinical relevance across multiple tumor types.
The collaboration demonstrates how large-scale real-world evidence can complement traditional clinical trial data, particularly in genomic subpopulations where enrolling sufficient patients into trials can be difficult.
“This approval highlights the growing role of real-world evidence in precision oncology and underscores the potential for new regulatory pathways in rare biomarker-defined populations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “InfinityAI allows us to generate clinically meaningful evidence from large-scale, longitudinal data, helping to complement traditional trials and ultimately expand access to targeted therapies for patients who might otherwise be overlooked.”
About InfinityAI
InfinityAI is Guardant Health’s artificial intelligence and machine learning platform designed to generate real-world evidence and data-driven insights. The platform is built on a large proprietary dataset derived from Guardant Health’s clinical testing portfolio and integrates longitudinal, multimodal molecular and clinical information, including genomic and epigenomic data, into a unified framework.
InfinityAI supports pharmaceutical and healthcare partners across research, drug development and clinical applications such as biomarker discovery, patient identification and clinical trial optimization. Its analytics tools are designed to enable more informed decision-making and improve both development efficiency and patient outcomes.
More about Guardant Health
Guardant Health is a precision oncology company focused on improving cancer detection and treatment through advanced diagnostics and data analytics. Founded in 2012, the company develops blood and tissue-based tests, real-world data platforms and AI-driven insights designed to help identify cancer earlier, monitor recurrence and guide treatment decisions for patients with advanced disease.