Guardant Health and Washington University to present study at 2024 ASCO meeting highlighting utility of ctDNA to address racial inequities in the use of targeted therapies and enrollment in clinical trials

• Data from study using Guardant360® blood test show Black patients with PIK3CA mutations in advanced breast cancer were less likely than White patients to be enrolled in clinical trials and receive targeted therapy
• Study is part of collaboration between Guardant Health and Multicenter Precision Medicine Academic Consortium (PMAC) using liquid biopsy to achieve equitable use of precision medicine therapies in patients with metastatic breast cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced its research collaborators from Washington University’s Siteman Cancer Center will lead an oral presentation today at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting highlighting the potential role of liquid biopsy in addressing racial inequities in enrollment in clinical trials and in the use of targeted therapies for advanced breast cancer.

The Rapid Oral Abstract Session (#1017), titled “Racial differences in genomic profiles and targeted treatment use in ER+ HER2- metastatic breast cancer,” will be held between 11:30 am and 1:00 pm CT in Hall D1.

The retrospective study, led by first author Emily Podany, MD, and senior author Andrew Davis, MD, both from Washington University, focused on patients with hormone receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer with PIK3CA mutations, which had an equal incidence in Black and White patients. The 1,327 patients in the study, who were treated at Washington University in St. Louis, Massachusetts General Hospital, and Northwestern University, had the Guardant360 liquid biopsy test as part of clinical care and these results were combined with annotated clinical data. Results indicated that Black patients were significantly less likely than White patients to receive PIK3CA targeted therapy or to be enrolled in a clinical trial for biomarkers that required targetable mutations identified via circulating tumor DNA (ctDNA). There were no differences in the use of therapies that did not require a targetable mutation identified via ctDNA.

“These data show clinical inequities in the use of targeted therapies and enrollment in clinical trials, which must be the focus of future interventions,” said Podany. “We must now identify ways to ensure all patients equitably receive the recommended precision medicine treatments based on the results of ctDNA testing.”

“These data highlight the importance of using ctDNA to identify targetable mutations,” noted Davis. “And they reinforce the urgent need to ensure equitable implementation of precision medicine therapies for patients of all races.”

The study is part of an ongoing collaboration between Guardant Health and the multicenter Precision Medicine Academic Consortium (PMAC) aimed at advancing the use of liquid biopsy in patients with metastatic breast cancer.

“This landmark study highlights the importance of equitable access to precision medicine,” said Craig Eagle, MD, chief medical officer of Guardant Health. “The results confirm the potential role liquid biopsy can have in helping researchers and clinicians equitably match patients with appropriate trials and clinically effective therapies.”

Currently, PMAC is working with Guardant Health to validate genomic findings from this and prior projects using the GuardantINFORM clinical-genomic dataset of over 400,000 patients with advanced cancer. The collaboration will continue to pursue future research focused on increasing equitable utilization of targeted therapies.

“The current study demonstrates the importance of studying real-world annotated molecular data related to the use of ctDNA testing and targeted therapies in advanced cancer,” said Massimo Cristofanilli, MD, co-founder of PMAC. “It provides valuable insights that can help us understand the complex relation among biological, ethnic and social diversity and offers potential tools to overcome inequity in care.”

The full abstract for the study and a list of all abstracts being presented at the meeting can be found at the ASCO website.

For more information and updates from the meeting, follow Guardant Health on LinkedIn and X (Twitter) or visit ASCO booth #28115.

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 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 helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

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, 2023, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. 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.

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