Press Release

Data Presented at ESMO Show Metastatic CRC Patients with HER2 Amplification Detected by Guardant360 Experience Clinical Benefit After Targeted Therapy

September 28, 2019 at 1:05 PM EDT
Supports Recent Addition of HER2 Blockade Therapy to NCCN Guidelines for Treatment Refractory mCRC Patients
 

BARCELONA, Spain, Sept. 28, 2019 (GLOBE NEWSWIRE) -- Guardant Health and the National Cancer Center Hospital East will present data at the European Society of Medical Oncology (ESMO) conference from a prospective, multi-center phase II clinical trial (TRIUMPH). Study showed that patients with metastatic colorectal cancer (mCRC) with a HER2 (ERBB2) amplification detected by the Guardant360® assay experienced clinical benefit from National Comprehensive Cancer Network (NCCN) guideline-recommended HER2-directed combination therapy.

The study, to be presented at a poster discussion session on September 29, included patients with RAS-wild-type mCRC refractory to standard EGFR-directed therapies, and HER2 amplification detected using standard tissue-based testing or Guardant360.

An interim analysis, led by principal investigators from the National Cancer Center Hospital East in Japan, demonstrated that mCRC patients with HER2 amplification detected by Guardant360 and treated with HER2-directed combination therapy (trastuzumab and pertuzumab) achieved an objective response rate (ORR) of 33.3% (95% CI, 11.8-61.6%). Excluding patients with known markers of resistance detected by Guardant360, the ORR was 45.5% (95% CI, 16.7-76.6%). The overall median progression-free survival (PFS) was 4.0 months (95% CI, 1.3-5.6 months), and the median duration of response was 4.2 months (95% CI, 3.8 months-not reached). Importantly, patients with HER2-amplified tumors who also had Guardant360-detected mutations in KRAS, NRAS, PIK3CA or HER2 had much poorer responses and shorter PFS. In contrast, median PFS was 5.6 months (95% CI, 1.3-6.2 months) when mutations in these genes were not detected by Guardant360.

“This study, led by Drs. Yoshino and Nakamura, underscores the increasing importance of identifying targetable HER2 amplifications across cancer types. It confirms findings from the previous HERACLES trial that comprehensive circulating-tumor DNA testing can identify patients with HER2 amplification with high sensitivity, as well as genomic mutations that predict lack of response,” said Guardant Health Global Chief Medical Officer Rick Lanman, MD. “Virtually no patients’ tumors with advanced CRC are tested for HER2 amplification unless they are getting next-generation sequencing. Because Guardant360 is non-invasive and highly sensitive for HER2 amplifications, it can help fill a critical gap in making sure every patient gets comprehensively tested.”

“Tissue analysis has been the standard for detecting biomarkers, including HER2 amplification. However, tissue analysis has inherent limitations, such as the invasiveness of sampling procedure and the long turnaround time. The results of the TRIUMPH study strongly suggested that circulating-tumor DNA analysis can equally identify patients with HER2-amplified mCRC who benefit from the dual HER2-targeted therapy as the tissue analysis. The implementation of Guardant360 for the treatment for patients with HER2-amplified mCRC will be useful for precision medicine of mCRC,” said the Principal Investigator of this study Dr. Yoshiaki Nakamura.

HER2-directed combination therapy was added this year to NCCN guidelines for use in mCRC, adding to several other solid-tumor cancers where this biomarker is relevant for treatment decisions.

The following posters across the continuum of cancer care will be presented:

                                                              
Poster DiscussionsDateTimeLocation
TRIUMPH: Primary Efficacy of a Phase II Trial of Trastuzumab (T) and Pertuzumab (P) in Patients (pts) with Metastatic Colorectal Cancer (mCRC) with HER2 (ERBB2) Amplification (amp) in Tumor Tissue or Circulating Tumor DNA (ctDNA): A GOZILA Sub-study9/293:00 p.m.Cordoba Auditorium (Hall 7)
Impact of clonality and DNA repair mutations on plasma tumor mutation burden (pTMB) and immunotherapy efficacy in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) in CCTG CO.269/293:25 p.m.Cordoba Auditorium (Hall 7)
Determinants of response of HER2+ gastric cancer (GC) vs gastroesophageal junction adenocarcinoma (GEJ) to margetuximab (M) plus pembrolizumab (P) post trastuzumab (T)9/309:05 a.m.Malaga Auditorium (Hall 5)
Poster Presentations   
Application of ESCAT and OncoKB scales in liquid biopsy (LB) in advanced NSCLC patients (pts): Is it feasible and reliable?9/2812:00 p.m.Poster Area (Hall 4)
A large scale prospective concordance study of oncogene driver detection between plasma- and tissue-based NGS analysis in advanced non-small cell lung cancer (NSCLC)9/2812:00 p.m.Poster Area (Hall 4)
Combined genomic and epigenomic assessment of cell-free circulating tumour DNA (cfDNA) for cancer diagnosis and recurrence-risk assessment in early-stage lung cancer9/3012:00 p.m.Poster Area (Hall 4) 
Cell-Free DNA to detect focal versus non-focal MET amplification in metastatic colorectal cancer patients: Combined analysis from Japan and the United States9/3012:00 p.m.Poster Area (Hall 4)
Biological difference of tumor mutational burden (TMB) and microsatellite instability (MSI) status in patients (pts) with somatic vs. germline BRCA1/2-mutated advanced gastrointestinal (GI) cancers using cell-free DNA (cfDNA) sequencing analysis in the GOZILA Study9/3012:00 p.m.Poster Area (Hall 4)

 

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. Its 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 Health has 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 6,000 oncologists, over 50 bio-pharmaceutical companies and all 28 of the National Comprehensive Cancer Network centers.

Forward Looking Statements
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Investor Contact:
Lynn Lewis or Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene or Ian Stone
press@guardanthealth.com

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Source: Guardant Health, Inc.