Phase 2 trial of Amgen’s investigational KRAS^G12C inhibitor, sotorasib, demonstrated comparable efficacy between patients identified as KRAS^G12C positive using Guardant360 CDx liquid biopsy or tissue biopsy

Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, presents new data at the AACR Virtual Annual Meeting I, April 10-15, 2021, highlighting the use of the company’s proprietary blood tests to advance precision oncology.

Key findings demonstrate the value of Guardant360^®, Guardant360 CDx, and GuardantOMNI™ liquid biopsy tests to detect clinically actionable mutations, inform treatment for patients as their cancer progresses, and reveal tumor evolution and resistance in response to interventional therapies, including immunotherapies.

“At this year’s AACR, we highlight the growing clinical utility of our liquid biopsy tests, from revealing critical genomic and molecular insights that contribute to vitally important drug development efforts, to further informing treatment decisions as patients with advanced disease progress,” said Helmy Eltoukhy, Guardant Health CEO. “As we exit the pandemic, the ability to effectively treat advanced cancers that may have remained undetected during the past year will be critical, and there is no room for error or further delays in finding the right treatment or clinical trial. Now more than ever, our liquid biopsies are needed to accelerate the accessibility of effective treatment options for patients most in need of precise clinical therapies.”

Guardant360 CDx validated for use with Amgen’s investigational KRAS^G12C inhibitor, sotorasib

Data from the phase 2 CodeBreaK 100 trial evaluating investigational sotorasib in patients with advanced non-small cell lung cancer (NSCLC) showed the objective response rate was comparable in patients selected using Guardant360 CDx liquid biopsy or tissue biopsy, with high concordance demonstrated between the two assays.

“The study results highlight that the Guardant360 blood-based companion diagnostic test was effective at selecting patients with KRAS G12C who may benefit from treatment with sotorasib, said Darryl Sleep, senior vice president, global medical and chief medical officer, Amgen. “KRAS G12C can only be detected with a biomarker test and with one in eight patients with NSCLC harboring the KRAS G12C mutation, there is a critical need to improve access to high quality diagnostics and more routine screening.”

Guardant360 CDx delivers results at low inputs, which can potentially increase patient samples for clinical decision-making and clinical studies

Study shows Guardant360 CDx provides comprehensive tumor profiling results with robust analytical performance at demonstrated low inputs (5ng cutoff). These data suggest that Guardant360 CDx has the potential to guide therapy decisions for about 34% more patients compared to some liquid biopsies that use 2 blood collection tubes (BCT) for minimal 30ng of cell-free DNA (cfDNA). The data also show that the ability to process samples below 15ng input from a single BCT increases the yield of EGFR driver mutations by >25%. Furthermore, because retrospective studies are often performed with as little as 2mL of plasma, the study shows that the Guardant360 CDx is expected to return valid results on over 88% of such samples, which may be outside the performance specifications for other assays.

Studies show Guardant360 provides early indication of treatment response and resistance mechanisms in the management of advanced cancer

Data presented are consistent with prior studies, across various treatments and indications,^1-10 showing Guardant360 provides early indication of treatment response and clinical outcomes by measuring molecular response or changes to circulating tumor DNA from baseline at different time-points. In addition, data presented show that Guardant360 can also reveal tumor evolution and resistance in response to interventional therapies, including immunotherapies.

Other abstracts and poster presentations

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, and GuardantOMNI^® tests for advanced-stage cancer patients, and Guardant Reveal^™ test 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 and individuals at a higher risk for developing cancer with early detection.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential scope, impact, or benefit of Guardant Health liquid biopsies, 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 as well as in its other reports filed with the Securities and Exchange Commission, including, when filed, 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.

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