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10-Apr-2021

Data at AACR Demonstrate Growing Clinical Utility of Guardant Health Liquid Biopsies in the Treatment and Management of Advanced Cancers

Phase 2 trial of Amgen’s investigational KRASG12C inhibitor, sotorasib, demonstrated comparable efficacy between patients identified as KRASG12C positive using Guardant360 CDx liquid biopsy or tissue biopsy

REDWOOD CITY, Calif.--(BUSINESS WIRE)--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 KRASG12C 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.”

Title

Clinical validation of plasma cell-free DNA (cfDNA) sequencing in the phase 2 trial of sotorasib in patients (pts) with KRAS p.G12C mutated NSCLC

Abstract No.

CT181

Session

Phase II Clinical Trials

Date / Time

e-Poster Presentation: April 10, 2021, 8:30 AM – 11:59 PM EDT

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.

Title

The liquid biopsy Guardant360 CDx has robust performance at low inputs allowing for high rate of returning patient results

Abstract No.

572

Session

Liquid Biopsies: Circulating DNA

Date / Time

April 10, 2021, 8:30 AM - 11:59 PM EDT

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.

Title

Reversion patterns in homologous recombination repair genes in metastatic cancer patients profiled by cell-free DNA

Abstract No.

25

Session

Biomarkers

Date / Time

MINISYMPOSIUM PRESENTATION
April 10, 2021, 2:20 PM - 2:30 PM EDT

Title

Comparison of molecular response calculations for prediction of patient outcome

Abstract No.

401

Session

Biomarkers Predictive of Therapeutic Benefit

Date / Time

Poster presentation: April 10, 2021, 8:30 AM – 11:59 PM EDT

Other abstracts and poster presentations

Title

Confirmation of Target Inhibition and Anti-Tumor Activity of the SHP2 Inhibitor RMC-4630 via Longitudinal Analysis of ctDNA in RAS-Addicted Tumors in a Phase 1 Clinical Study

Title

A single institution experience with Guardant360 liquid biopsy for therapeutic decision in advanced solid tumors

Title

NTRK1 fusion detection from clinical cfDNA NGS using a de novo fusion caller

Title

Detection of somatic copy number alterations from on-target and off-target sequencing data

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 Revealtest 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.

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.20.00321.


Contacts

Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene
press@guardanthealth.com

Julie Johnson
julie.johnson@uncappedcommunications.com

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Last Updated: 10-Apr-2021