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

Key Terms

real-world evidence medical

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

real-world data medical

Real-world data consists of information collected from everyday sources outside of controlled experiments or official reports, such as patient records, insurance claims, or wearable device readings. For investors, it provides a more complete picture of how products and services perform in actual use, helping them make better-informed decisions based on how things work in real life rather than just in theory or controlled settings.

biomarker-defined medical

A biomarker-defined product or trial targets patients selected because they carry a measurable biological sign—such as a gene change, protein level, or other lab result—that predicts a likely response to the drug or treatment. For investors, this matters because focusing on a clearly identified subgroup can make clinical trials smaller, faster and more likely to succeed, but it can also limit the total number of patients who can use the therapy, affecting potential market size.

her2-positive medical

HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.

erbb2 medical

ERBB2 is a gene that makes a protein acting like a cell’s growth switch; when it is overactive or present in extra copies, it can drive certain cancers. Investors care because ERBB2 status determines use of specific diagnostics and therapies, shaping demand for drugs, tests, patents and treatment guidelines—similar to knowing whether a vehicle has a powerful engine that requires a particular kind of brake system.

immunohistochemistry medical

Immunohistochemistry is a laboratory method that uses labelled antibodies to highlight specific proteins inside thin slices of tissue, producing visible color where those proteins are present—like using colored highlighters to mark words on a page. Investors care because it provides concrete evidence about whether a drug hits its intended target, whether a diagnostic test works, and how a treatment affects tissues, all of which can affect clinical success, regulatory approval, and market value.

metastatic medical

Metastatic describes cancer that has spread from its original spot to other organs or tissues, like weeds moving from one garden bed into several others. For investors, metastatic disease matters because it often requires more complex, long-term treatments, larger clinical trials, and can drive demand for specialized drugs and diagnostics—factors that affect a drug’s development costs, regulatory risk, market size, and potential revenue.

real-world data (rwd) medical

Real-world data are health and clinical information collected outside controlled clinical trials — from sources such as electronic health records, insurance claims, patient registries, wearable devices and pharmacy records. Investors care because this evidence shows how treatments or medical products actually perform in everyday use, informing market demand, regulatory decisions, reimbursement and commercial forecasts; think of it as street-level traffic data that complements lab tests and reduces uncertainty about real-market performance.

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• 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.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260330846159/en/

Investor Contact:
Zarak Khurshid
investors@guardanthealth.com

Media Contact:
Meaghan Smith
press@guardanthealth.com

Source: Guardant Health, Inc.