Guardant Health’s InfinityAI Real-World Evidence Supports Approval of ENHERTU® for Previously Treated Patients with HER2-Positive Metastatic Solid Tumors in Japan

• This milestone underscores the power of Guardant Health’s InfinityAI platform and real-world data to enable innovative evidence generation in rare biomarker-defined populations

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that real-world evidence generated from Guardant’s InfinityAI contributed to the recent approval of ENHERTU® (trastuzumab deruxtecan), developed and commercialized by Daiichi Sankyo (TSE:4568) in Japan, for the treatment of patients with HER2-positive (HER2 [ERBB2] gene amplification or immunohistochemistry [IHC] 3+) advanced or recurrent solid cancers refractory or intolerant to standard treatments. This approval, granted by Japan’s Ministry of Health, Labour and Welfare (MHLW), was supported by data from the HERALD, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 clinical trials and supplemental real-world evidence (RWE) generated using the real-world data platform from InfinityAI, Guardant Health’s artificial intelligence platform.

HER2 amplification is well characterized in breast cancer but patient identification and evidence continues to be challenging. In biomarker-defined populations with low prevalence, real-world data (RWD) can play a critical role in identifying patients at scale and characterizing unmet need.

To support its MHLW application, Daiichi Sankyo incorporated real-world evidence generated from InfinityAI as supplemental data alongside clinical findings. Together, Guardant Health and Daiichi Sankyo analyzed outcomes from a large cohort of patients with HER2 amplifications detected via Guardant360®, demonstrating significant unmet need and real-world clinical relevance across multiple tumor types.

The collaboration illustrates an innovative pathway that leverages high-quality RWE to complement clinical trial data, particularly in genomic subpopulations where traditional trial enrollment may be limited.

“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 for generating real-world evidence and data-driven insights. It is built on a large, proprietary dataset derived from Guardant Health’s clinical testing portfolio, integrating longitudinal, multimodal molecular and clinical data, including genomic and epigenomic information, into a unified framework. InfinityAI supports biopharma and healthcare partners across research, development, and clinical applications, including biomarker discovery, patient identification, and clinical trial optimization. Through flexible data and analytics solutions, InfinityAI enables more informed decision-making to improve development efficiency and patient outcomes.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

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