Guardant360 test results may provide prognostic information beyond the detection of actionable biomarkers for ALK-rearranged NSCLC patients

SINGAPORE,May 30,2020 --According to the data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on 29 May 2020,researchersat Samsung Medical Center in Seoul,Korea,have found useful prognostic information beyond actionable biomarkers when the Guardant360®test is performed on ALK-rearranged (ALK positive) non-small cell lung cancer (NSCLC) patients. The poster presentation is entitled "Longitudinal monitoring of next generation sequencing (NGS) of plasma cell-free DNA in ALK-rearranged NSCLC patients treated with ALK tyrosine inhibitors".

Patients with known ALK positive advanced stage NSCLC had blood collected prior to the start of ALK-targeted treatment,2 months after treatment began,and when the cancer progressed. The main findings of this study showed that the absence of tumour-derived cfDNA prior to and disappearance of cfDNA 2 months after starting ALK-targeted treatment were both independently associated with longer progression-free survival (PFS) and overall survival (OS). The study also found that the co-occurrence of TP53 mutations and ALK alterations in cfDNA prior to treatment was associated with shorter PFS and OS in patients with ALK positive NSCLC.

Dr. Minsuk Kwon,the first author and recipient of the Conquer Cancer Foundation Merit Award said,"It is absolutely important to identify ALK fusions for appropriate treatment selection. In this study,we also found that the clearance of tumour cfDNA after two months of first line ALK TKI therapy predicted better treatment and survival outcome in ALK positive NSCLC patients."

Dr. Myung-Ju Ahn,Professor,Department of Hematology and Oncology,Samsung Medical Centerand corresponding author of the study said,"Normally,we evaluate cfDNA to identify actionable biomarkers in people with advanced non-small cell lung cancer,which we could do for most patients in this study.But we also found that when we could not detect any tumour DNA in blood prior to treatment there were favourable prognostic implications for patients with ALK positive disease."

"The Guardant360 assay,which requires only a simple blood draw,allowed these investigators to efficiently assess tumour DNA status before,during,and after treatment with targeted therapy. Their findings show the clinical utility of identifying biomarkers in cfDNA and the favourable prognostic significance of not detecting tumour cfDNA in people living with ALK positive non-small cell lung cancer," said Dr. Steve Olsen,Chief Medical Officer of Guardant Health Asia,Middle East and Africa (GH AMEA).

The Guardant360 test is increasingly being used to guide treatment in metastatic lung cancer as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing,Guardant360 analyses 74 genes using cell-free tumour DNA from blood samples.

Poster Presentation Title: Longitudinal monitoring by next generation sequencing of plasma cell-free DNA in ALK-rearranged non-small cell lung cancer (NSCLC) patients treated with ALK tyrosine kinase inhibitors.

Abstract Number: 9603

Poster Number: 369

Authors: Minsuk Kwon,Bo Mi Ku,Sehhoon Park,Hyun Ae Jung,Jong-Mu Sun,Se-Hoon Lee,Jin Seok Ahn,Keunchil Park,Myung-Ju Ahn; Division of Hematology-Oncology,Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine,Seoul,South Korea; Samsung Medical Center,South Korea; Sungkyunkwan University School of Medicine,South Korea

AboutGuardant Health AMEA

Guardant HealthAMEA is a joint venture between SoftBank and Guardant Health,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 is designed to leverage its capabilities in technology,clinical development,regulatory and reimbursement to drive commercial adoption,improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease,Guardant Healthhas launched multiple liquid biopsy-based tests,Guardant360 and GuardantOMNI,for advanced stage cancer patients,which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014,Guardant360 has been used by more than 7,000 oncologists,over 60 biopharmaceutical companies and all 28 National Comprehensive Cancer Network Centers in the United States. Visit us online at www.guardanthealthamea.com.

About Samsung Medical Center

When SMC opened in 1994,it changed the paradigm of healthcare by focusing on patient-centered care and a focus on customer satisfaction. SMC remains dedicated to improving health and enhancing the quality of life through the provision of state-of-the-art patient care,clinical research and education. During the past 20 years,SMC has won first place in the National Customer Satisfaction Index (NCSI) 14 times,first place in the Korean Customer Satisfaction Index (KCSI) 16 times,first place in the Korean Standard- Service Quality Index (KS-SQI) 12 times consecutively,and has been selected as the top medical center in the hospital sector in Brand Star 12 times consecutively.

SMC is the leading research-oriented hospital in Korea equipped with appropriate facilities and personnel,with the training,knowledge and experience necessary to conduct pre-clinical and clinical research. SMC plans to achieve medical innovation in the future to promote the happiness of patients and will develop into a global hub of biohealth care study and link the industry by connecting to hospitals,R&D Centers,schools,and enterprises. At the same time,SMC will create the image of a new future hospital as a public medical institution that leads social contribution. For more information on SMC,please visit SMC's website.

LOGO- /20200530/2817723-1LOGO?lang=0