Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations

Blood test provides simple way for oncologists to test patients with advanced NSCLC for genomic alterations that drive selection of HER2-targeted therapy

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic to select patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy for treatment with ENHERTU^® (trastuzumab deruxtecan). ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.

Mutations in the HER2 gene are responsible for approximately 2-4% of non-squamous NSCLC, which represents about 70% of NSCLC cases.^1,2 Overall, NSCLC accounts for about 80-85% of all lung cancer,³ the leading cause of cancer death for men and women worldwide.⁴ Guardant360 CDx is a next-generation sequencing-based assay that detects genomic alterations using circulating tumor DNA from blood. The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022.

“The ministry’s approval of Guardant360 CDx as a companion diagnostic for ENHERTU is great news for patients with metastatic non-small cell lung cancer with HER2 mutations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Oncologists in Japan now have the first blood-based companion diagnostic to determine if their patients are eligible to receive the first HER2 directed therapy approved to treat this specific condition. This is another step forward in achieving Guardant Health’s mission to conquer cancer globally.”

In March 2022, the MHLW approved the Guardant360 CDx test for comprehensive genomic profiling in patients with advanced solid tumors, and in July 2023, the test received national reimbursement approval in Japan. The MHLW also previously approved the test as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab), patients with MSI-High advanced colorectal cancer who may benefit from Opdivo® (nivolumab), and patients with metastatic NSCLC who may benefit from treatment with LUMAKRAS™ (sotorasib).

About Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, Guardant360 has become widely accepted for blood-based comprehensive genomic profiling with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 400,000 tests performed to date, and is broadly covered by Medicare and private payers, insuring over 300 million people.

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 GuardantINFINITY™ 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.

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, 2022, and any current and periodic 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.

References

1. N Engl J Med. 2022 Jan 20;386(3):241-251.
2. J Thorac Dis. 2010 Dec; 2(4): 199–204.
3. American Cancer Society. https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 19, 2023.
4. Cancer.net. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed August 19, 2023.

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