StemCell Therapy

REDWOOD CITY, Calif., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Despite longstanding medical guidelines recommending biomarker testing for all patients with metastatic colon cancer, a new study published in JCO Precision Oncology shows that only 40 percent of patients are tested according to guidelines.1 These findings are consistent with the rates seen in late-stage lung cancer, where clinical adoption of genomic profiling remains below the recommended standard-of-care guidelines.2 The result is that many patients are potentially being treated with less effective drugs, some having serious side-effects; while others are not being offered highly effective personalized treatment options.

The multi-center retrospective study also found that certain subgroups of patients were less likely to be tested than others. Suboptimal genotyping occurred more often if the patient was male, older than 65, progressed from early stage disease, or treated in a community cancer center. Furthermore, only 28 percent of patients on anti-EGFR treatments received the necessary testing to determine eligibility. This study also showed that using a comprehensive panel, as opposed to single-gene testing, could possibly result in a 50 percent increase in guideline-recommended testing rates.

For over a decade, medical guidelines have recommended multigene mutation testing for metastatic colon and rectal cancer patients to ensure patients receive the optimal treatment available. While the study shows that testing has improved slightly, the disappointing reality is that the majority of patients, including those receiving targeted treatments, are not being comprehensively tested, said Stuart Goldberg, MD, a lead study investigator who served as chief scientific officer at COTA, Inc. during the project. Personalized medicine holds great promise for achieving better outcomes, but we will not see the benefits until genomic testing is routinely adopted into clinical practice.

Newly available therapies routinely help some people with metastatic colorectal cancer gain a year or two of life, but these novel treatments cannot be applied unless comprehensive genotyping is routinely performed, said Richard Lanman, MD, Guardant Health Global Chief Medical Officer. Just as concerning was that 28 percent of patients received targeted treatments without being tested, and for some we would have known in advance that the treatment was not going to work. At Guardant we are committed to helping reverse this trend by helping to educate oncologists and offering a non-invasive and comprehensive genomic testing solution that overcomes the limitations of tissue biopsies with our Guardant360 blood test.

The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines recommend biomarker testing for all patients with metastatic colon cancer to screen for genomic alterations in KRAS, NRAS, BRAF, ERBB2 (HER2), NTRK and microsatellite instability (MSI) to help guide more effective treatment decisions. Targeted therapies and immunotherapies have been shown to improve clinical outcomes. For example, anti-EGFR therapies are commonly used in treating metastatic colon cancer but are not efficacious in patients whose tumors harbor KRAS, NRAS, or BRAF V600E mutations.3 Additionally, immunotherapy is effective in patients with MSI and anti-HER2 treatment is effective in patients with ERBB2 (HER2) amplifications.4,5 Professional guidelines continue to be updated as new therapies come to market such as the recent recommendation to test patients for NTRK fusions because they may benefit from treatment with tumor-agnostic NTRK inhibitors.

Study details can be found here.

About Guardant HealthGuardant 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 launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients and LUNAR assay for research use and for use in prospective clinical trials. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Healths products, which involve risks and uncertainties that could cause Guardant Healths 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 Healths 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 caption Risk Factors in Guardant Healths Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. 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 Healths views as of any date subsequent to the date of this press release.

In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:Lynn Lewis or Carrie Mendivilinvestors@guardanthealth.com

Media Contact:Anna Czene or Ian Stonepress@guardanthealth.com

References1. Gutierrez ME, Price KS, Lanman RB, et al. Genomic Profiling for KRAS, NRAS, BRAF, Microsatellite Instability (MSI) and Mismatch Repair Deficiency (dMMR) among Patients with Metastatic Colon Cancer. JCO Precision Oncol. December 20192. 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. Clin Cancer Res. April 20193. Van Cutsem E, Khne CH, Lng I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. May 20114. Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. March 20185. Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. April 2016

See the article here:
Study Shows Only 40 Percent of Patients with Metastatic Colon Cancer Receive Guideline-Recommended Biomarker Testing - GlobeNewswire

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