Guardant Health and The Royal Marsden NHS Foundation Trust partner on highly anticipated TRACC Part C trial to use Guardant Reveal™ blood test to help guide treatment decisions in colorectal cancer

• Trial will evaluate use of circulating tumor DNA to guide chemotherapy treatment decisions following surgery for stage II-III colorectal cancer patients based on test results for minimal residual disease with Guardant Reveal™ blood test
• Study involving approximately 40 sites and 1600+ patients across the United Kingdom aims to evaluate opportunity to improve patient care and quality of life by reducing unnecessary use of chemotherapy

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, is partnering with The Royal Marsden NHS Foundation Trust on Part C of its “Tracking mutations in cell free DNA to predict Relapse in eArly Colorectal Cancer” (TRACC) study, which will evaluate the use of circulating tumor DNA (ctDNA) to guide chemotherapy treatment decisions after curative-intent surgery in patients with early-stage colorectal cancer (CRC). The trial is intended to determine whether patients can be spared unnecessary chemotherapy and the associated side effects if they test negative for ctDNA using the Guardant Reveal™ blood test following surgery.

Currently, many patients with high-risk stage II and stage III CRC are routinely offered chemotherapy after surgery to help reduce the risk of relapse from microscopic minimal residual disease (MRD). However, approximately 50-80% of these patients are cured with surgery alone, and many may be over-treated because doctors have not been able to clearly advise patients on whether they are likely to benefit from the treatment.^1,2,3 Chemotherapy can cause debilitating and sometimes life-long side-effects, such as damage to the nerves in the hands and feet, life-threatening infections and blood clots.

The study will use the Guardant Reveal blood test to detect MRD by measuring the DNA shed from tumor cells into the bloodstream. Global studies have shown that a negative ctDNA result after surgery is associated with a significantly lower likelihood of the cancer returning.⁴ The TRACC Part C trial aims to evaluate the use of ctDNA results from the Guardant Reveal test to guide chemotherapy treatment decisions in a multi-center, prospective, randomized study over the next four years.

“Patients with high-risk colorectal cancer are often over-treated and can suffer long-term neurotoxicity from chemotherapy,” said Professor David Cunningham, director of clinical research at The Royal Marsden NHS Foundation Trust, chief investigator for the TRACC Part C study. “This study will generate evidence and insights to help us understand when we can avoid unnecessary chemotherapy for our patients who have no disease detected following surgery. This information can help us tailor treatment decisions to benefit patients and potentially realize significant cost savings for the healthcare system.”

“With the Guardant Reveal test, a simple blood draw can be used to identify colorectal cancer patients who have residual disease and are most likely to benefit from adjuvant therapy,” said Helmy Eltoukhy, Guardant Health co-CEO. “We’re pleased to partner with The Royal Marsden in the TRACC Part C study to enable the investigators to more accurately predict when cancer is unlikely to return, help guide chemotherapy treatment decisions and provide patients with a better quality of life.”

TRACC Part C began opening sites in August 2022 and will involve approximately 40 sites across the United Kingdom with a planned recruitment of 1,621 patients over four years. The Royal Marsden NHS Foundation Trust announced that the first patient was enrolled in TRACC Part C in September 2022. The trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute of Health Research (NIHR) partnership.

More information about the TRACC Part C study is available at clinicaltrials.gov. To learn more about Guardant Reveal, visit www.guardantreveal.com.

About Guardant Reveal

Guardant Reveal is the first blood-only test that detects residual and recurrent disease in patients with Stage II and III colorectal, breast or lung cancer without the need for a tissue biopsy. Combining genomic and epigenomic signals, the test detects ctDNA in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and to monitor for recurrence of disease in previously diagnosed patients. For more information, visit guardantreveal.com.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

About The Royal Marsden NHS Foundation Trust

The Royal Marsden opened its doors in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education. Today, together with its academic partner, The Institute of Cancer Research (ICR), it is the largest and most comprehensive cancer centre in Europe seeing and treating over 59,000 NHS and private patients every year. It is a centre of excellence with an international reputation for groundbreaking research and pioneering the very latest in cancer treatments and technologies. The Royal Marsden, with the ICR, is the only National Institute for Health Research Biomedical Research Centre for Cancer. This supports pioneering research work carried out over a number of different cancer themes. The Royal Marsden Cancer Charity raises money solely to support The Royal Marsden, a world-leading cancer centre. It ensures Royal Marsden nurses, doctors and research teams can provide the very best care and develop life-saving treatments, which are used across the UK and around the world. From funding state-of-the-art equipment and ground-breaking research, to creating the very best patient environments, The Royal Marsden Cancer Charity will never stop looking for ways to improve the lives of people affected by cancer.

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, 2021 and in its other reports filed with 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.

References

1. QUASAR collaborative group; Lancet 2007, 370: 2020-29.
2. Chakrabarti et al 2020. World J Gastroinest Oncol. DOI: 10.4251/wjgo.v12.i8.808.
3. ESMO 2020 Abstract: Parikh (Corcoran) Minimal residual disease (MRD) detection in colorectal cancer (CRC) using a plasma-only integrated genomic and epigenomic circulating tumor DNA (ctDNA) assay.
4. Parikh et al. Clin Cancer Res (2021) 27 (20): 5586–5594.

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