Guardant Health Expands Guardant360® Portfolio With New Tests for Treatment Response Monitoring and Complete Genomic Profiling

• New Guardant360 Response™ blood test predicts treatment response to immunotherapy and targeted therapy, up to eight weeks earlier than standard-of-care RECIST methods^1-11

• New Guardant360 TissueNext™ tissue biopsy test is now available for ordering alongside the Guardant360^® CDx blood test, providing oncologists an efficient “blood-first, tissue-next” approach for complete genomic testing

Guardant Health, Inc. (Nasdaq: GH) adds two new products to its portfolio to help improve the management of patients with late-stage and metastatic cancers. The Guardant360 Response™ test represents a breakthrough as the first commercially available, blood-only, liquid biopsy test that detects changes in circulating tumor DNA (ctDNA) levels to provide oncologists an early indication of a patient’s response to treatment. The Guardant360 TissueNext™ test, the company’s first tissue-based test, is now available, if needed, to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

Both products expand on the trusted Guardant360^® portfolio to offer oncologists end-to-end testing solutions, covering treatment selection, with the option of ordering tissue biopsy results if needed, and treatment response monitoring, to help improve clinical outcomes for patients with advanced cancer.

The Guardant360 Response liquid biopsy test detects changes in ctDNA levels from a simple blood draw, to assess treatment response up to eight weeks earlier than RECIST (Response Evaluation Criteria in Solid Tumors),^1-11 giving oncologists a new tool to use when considering whether to continue, stop, or explore other treatment options for their patients with late-stage or metastatic cancer. Molecular responders (those with decreasing ctDNA levels) show significantly longer progression-free and overall survival rates, compared to molecular non-responders.^1-12 In over 50 studies, Guardant Health has demonstrated that molecular response, as measured by changes in ctDNA levels, can help provide an early indication of treatment response across therapies (targeted, immunotherapy, and chemotherapy) and cancer types including non-small cell lung, colorectal, breast, and bladder.^1-12

“Using circulating tumor DNA levels to monitor treatment response is a promising new approach in the management of patients with advanced cancer,” said Craig Eagle, MD, Guardant Health Chief Medical Officer. “We are delighted to offer oncologists a simple blood test that can provide an early assessment of whether their patient is responding to treatment, or not. Multiple studies using the Guardant360 Response test have shown that molecular response, as measured by circulating tumor DNA levels, can help predict clinical benefit, and longer progression-free survival.”

The Guardant360 TissueNext test can now be ordered, alongside the Guardant360 CDx blood test, to prepare for cases when the Guardant360 CDx test does not find actionable biomarkers. While starting with the Guardant360 CDx blood test to perform complete genomic testing finds nearly 80 percent of patients with actionable biomarkers in only seven days,^13-15 compared to finding only 50 percent of patients when starting with a tissue biopsy, and which can take two to four times longer,^13-15 there are cases when results are needed from a tissue biopsy. The new Guardant360 TissueNext test offers oncologists the most efficient “blood-first, tissue-next” workflow to complete genomic testing, ensuring that as many patients as possible are identified who may benefit from biomarker-informed treatment.

“With the new Guardant360 Response blood test, we are excited to offer a cutting-edge test able to predict patient response to treatment sooner than standard radiographic assessment, to help inform clinical decisions and improve outcomes,” said Helmy Eltoukhy, Guardant Health CEO. “By broadening our Guardant360 portfolio to cover not only treatment selection but treatment response, we provide oncologists a more complete view of their patient’s tumor evolution and resistance to interventional therapies, including immunotherapies. Furthermore, while starting with the Guardant360 CDx liquid biopsy for biomarker testing is shown to be more efficient than starting with an invasive tissue biopsy^13-15 which has a longer turn-around time to return results, the addition of our new Guardant360 TissueNext test strengthens our treatment selection offering, by providing oncologists the benefits of ‘blood-first, tissue-next’ testing options to find as many patients as possible, who may benefit from biomarker-informed treatment.”

The Guardant360 CDx test, the new Guardant360 TissueNext test, and the new Guardant360 Response test are all part of the Guardant360 portfolio, which provides oncologists a more complete genomic picture across the treatment journey. This comprehensive set of cancer tests empowers oncologists to optimize treatment, and know confidently what to do next. From fast treatment selection, starting first with the FDA-approved Guardant360 CDx test, to reflex testing with the Guardant360 TissueNext test, if needed, to early treatment response monitoring with the Guardant360 Response test, the Guardant360 portfolio helps oncologists unlock the full potential of precision oncology for their patients with late-stage and metastatic cancers.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 liquid biopsy-based Guardant360^®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI^® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

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, 2020 and in its other reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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. Raja R, Kuziora M, Philip Z. Brohawn PZ, et al. Early Reduction in ctDNA Predicts Survival in Patients with Lung and Bladder Cancer Treated with Durvalumab. Clin Cancer Res; 2018: 24(24): 6212-6222. DOI: 10.1158/1078-0432.CCR-18-0386.

2. Aggarwal C, Thompson JC, Chien A, et al. Dynamic monitoring of circulating tumor DNA next-generation gene sequencing as a predictive biomarker of response and progression-free survival after pembrolizumab monotherapy in patients with advanced NSCLC.J Clin Oncol; 2019: 37:15 suppl, 3040-3040. DOI:10.1200/JCO.2019.37.15.

3. Kim ST, Cristescu R, Bass AJ, et al. Comprehensive molecular characterization of clinical responses to PD-1 inhibition in metastatic gastric cancer. Nat Med; 2018: 24(9):1449-1458. DOI: 10.1038/s41591-018-0101-z.

4. Shaw AT, Martini JF, Besse B, et al. Early circulating tumor (ct)DNA dynamics and efficacy of lorlatinib in patients (pts) with advanced ALK-positive non-small cell lung cancer (NSCLC). J Clin Oncol; 2019: 37:15_suppl, 9019-9019. DOI: 10.1200/JCO.2019.37.15.

5. Pascual J, Cutts RJ, Kingston B, et al. Assessment of early ctDNA dynamics to predict efficacy of targeted therapies in metastatic breast cancer: Results from plasmaMATCH trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS5-02.DOI: 10.1158/1538-7445.SABCS20-PS5-02.

6. Mack PC, Redman MW, Moon J, et al. Residual circulating tumor DNA (ctDNA) after two months of therapy to predict progression-free and overall survival in patients treated on S1403 with afatinib +/- cetuximab.J Clin Oncol; 2020: 38:15_suppl, 9532-9532. DOI: 10.1200/JCO.2020.38.15.

7. Maron SB, Chatila WK, Millang BM, et al, Pembrolizumab with trastuzumab and chemotherapy (PTC) in HER2-positive metastatic esophagogastric cancer (mEG): Plasma and tumor-based biomarker analysis. J Clin Oncol; 2020: 38:15_suppl, 4559-4559. DOI: 10.1200/JCO.2020.38.15.

8. Modi S, Park H, Murthy RK, et al. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol; 2020: 38(17):1887-1896. DOI: 10.1200/JCO.19.02318.

9. Zhang Q, Luo J, Wu S, et al. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov; 2020: 10:12, 1842-1853. DOI: 10.1158/2159-8290.CD-20-0047.

10. Thompson JC, Carpenter EL, Silva BA, et al. Serial Monitoring of Circulating Tumor DNA by Next-Generation Gene Sequencing as a Biomarker of Response and Survival in Patients With Advanced NSCLC Receiving Pembrolizumab-Based Therapy. JCO Precis; 2021: 5, 510-524. DOI: 10.1200/PO.20.0032.

11. Wang C, Chevalier D, Saluja J, et al. Regorafenib and Nivolumab or Pembrolizumab Combination and Circulating Tumor DNA Response Assessment in Refractory Microsatellite Stable Colorectal Cancer. Oncologist. 2020 Aug;25(8):e1188-e1194. DOI: 10.1634/theoncologist.2020-0161. Epub 2020 May 30.

12. Guardant Health data on file. June 18, 2021.

13. Aggarwal C, Thompson JC, MD; Black TA, et al. Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non–Small Cell Lung Cancer. JAMA Oncology. 2019;5:173-180.

14. Palmero R, Taus A, Santiago V, et al. Biomarker Discovery and Outcomes for Comprehensive Cell-Free Circulating Tumor DNA Versus Standard-of-Care Tissue Testing in Advanced Non–Small-Cell Lung Cancer. JCO Precision Oncology. 5;2021:93-102.

15. Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non–small Cell Lung Cancer. Clinical Cancer Research. 2019;25:4691-4700.

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