Guardant Health's InfinityAI Real-World Evidence Supports Japan Approval Of ENHERTU For HER2-Positive Advanced Cancers Across Multiple Tumor Types

• 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

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.