Guardant Health Joins Forces With Patient Advocacy Groups to Raise Awareness of Importance of Complete Biomarker Testing for Patients With Advanced Colorectal Cancer

March 24, 2021 8:05 AM EDT

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Incomplete biomarker testing fails to meet current medical guideline standards, placing more than 60 percent1 of advanced colorectal cancer patients at risk of receiving a less effective treatment

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, is joining forces with leading patient advocacy groups to expand the Clear Your View initiative to raise awareness of the important role complete biomarker testing plays in guiding initial treatment decisions for newly diagnosed advanced colorectal cancer (CRC) patients. Current medical guidelines call for testing all six biomarkers in advanced CRC before starting treatment,2 yet more than 60 percent of patients are not receiving complete testing which puts them at risk for inappropriate therapy.1

Now in its second year, the Clear Your View campaign encourages oncologists to “stop, test, and wait” for complete biomarker testing results before starting first-line treatment. Last year, the campaign focused on improving biomarker testing rates in advanced non-small cell lung cancer (NSCLC), which remains suboptimal at 20 percent,3 and garnered support from patient advocacy groups GO2 Foundation for Lung Cancer, LUNGevity Foundation, ALK Positive, and Lung Cancer Action Network. Now the campaign expands its focus to colorectal cancer, the second leading cause of cancer death and third most commonly diagnosed cancer in the US,4 and garners support from Colorectal Cancer Alliance, Fight CRC, Global Colon Cancer Association, KRAS Kickers, and PALTOWN.

Targeted therapy matched to a patient’s genomic profile has been shown to significantly extend median overall survival rate for advanced CRC patients5 as well as NSCLC patients.7-13 Testing for all recommended biomarkers can help predict which patients are most likely to respond to a certain treatment and which will not respond, and is one of the best ways to ensure that the patient receives the best treatment from the start. For example, while over 60 percent of metastatic CRC patients have a biomarker that may predict poor response to anti-EGFR monoclonal antibody therapy, 72 percent of patients who received anti-EGFR therapy did not first complete guideline-aligned RAS and BRAF biomarker testing to determine eligibility – resulting in patients potentially receiving less efficacious, costly treatment.1 The growing number of targetable CRC biomarkers makes it imperative that all patients receive complete biomarker testing before starting first-line treatment.5

“For patients with advanced colorectal cancer, time is of the essence and receiving the best treatment from the start is critical in extending progression-free survival,” said Andrew Spiegel, co-founder and executive director of the Global Colon Cancer Association. “We are proud to support the Clear Your View campaign and stand committed alongside Guardant Health, Colorectal Cancer Alliance, Fight CRC, KRAS Kickers, and PALTOWN to raising awareness and urgency around the importance of complete biomarker testing to improve survival for patients.”

“Incredible progress has been made in personalized treatments for advanced colorectal cancer, including not only medicines in clinical trials, but available FDA-approved medicines, yet too many patients are missing out on these potentially life-changing treatments due to suboptimal biomarker testing rates,” said Helmy Eltoukhy, Guardant Health CEO. “Additionally, many patients are being treated with potentially less efficacious treatments. Through the expansion of the Clear Your View initiative, we join the colorectal cancer community in urging wider adoption of complete biomarker testing to help ensure the best treatments for all patients suffering from advanced cancer.”

The Clear Your View campaign is being delivered to oncologists nationwide. To learn more about the campaign and the importance of complete biomarker testing for all advanced NSCLC and CRC patients, visit: clearyourview.org.

About Colorectal Cancer Alliance (CCA)

The Colorectal Cancer Alliance is a national nonprofit committed to ending colorectal cancer. Working with our nation of passionate allies, we diligently support the needs of patients and families, caregivers, and survivors; eagerly raise awareness of preventative screening; and continually strive to fund critical research. As allies in the struggle, we are fiercely determined to end colorectal cancer within our lifetime. For more information, visit: ccalliance.org.

About Fight Colorectal Cancer (Fight CRC)

Fight Colorectal Cancer is the leading patient-empowerment and advocacy organization in the United States, providing balanced and objective information on colon and rectal cancer research, treatment, and policy. We are relentless champions of hope, focused on funding promising, high-impact research endeavors, while equipping advocates to influence legislation and policy for the collective good. For more information, visit: fightcolorectalcancer.org.

About Global Colon Cancer Association (GCCA)

The Global Colon Cancer Association advocates for patient-centered policy around the world to increase disease awareness, access to screening, and quality medical treatments. These efforts are done in partnership with the 50+ Patient Advocacy Organizations that are members of the GCCA. The Know Your Biomarker program was developed to educate the colorectal cancer community and encourage conversations with medical providers about getting biomarker testing and the impact it can have on treatment options. For more information, visit: www.knowyourbiomarker.org.

About KRAS Kickers

KRAS Kickers is a non-profit for KRAS biomarker patients, survivors, and their loved ones. We inspire hope to people by providing connections and resources to feel empowered as a patient. Within the group, we learn about the updated KRAS treatments and research data in patient friendly language, strengthening us from this network of resources brings encouragement from knowledge. With ongoing updates to clinical trials, information from medical experts allows the patients to partner with the medical community to kick cancer’s KRAS. For more information, visit: KRASKickers.org.

About PALTOWN

PALTOWN currently supports over 5600 patients and caregivers in its exclusive online community COLONTOWN, a unique model of patient-led empowerment, with over 120 private “neighborhoods” for patients and caregivers to gain the emotional and psychosocial support they need, as well as the latest science-based data to inform their care and treatment. For more information, visit: paltown.org.

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 and the Clear Your View campaign, 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. 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 Oncology. December 2019; 3:PO.19.00274.
  2. National Comprehensive Cancer Network. Guidelines for Patients: Colon Cancer 2018. https://www.nccn.org/patients/guidelines/content/PDF/colon-patient.pdf. Accessed online March 1, 2021.
  3. 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. 2019;25(15)4691-4700.
  4. www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html Accessed online March 1, 2021.
  5. Kopetz S, Grothey A, Yaeger R, Cutsem E, et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. New England Journal of Medicine. 2019; 381:1632-1643.
  6. www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications Accessed online March 1, 2021.
  7. Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Annals of Oncology 2019; 30(7):1121-1126.
  8. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Annals of Oncology 2019; 30 (5): v851-v934.
  9. Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. J Clin Oncol. 2019 37:18_suppl, LBA9015-LBA9015.
  10. Camidge DR, Dziadziuszko R, Peters S et al. Updated Efficacy and Safety Data and Impact of the EML4-ALK Fusion Variant on the Efficacy of Alectinib in Untreated ALK-Positive Advanced Non–Small Cell Lung Cancer in the Global Phase III ALEX Study. J Thorac Oncol. 2019;14(7):1233-1243.
  11. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/ Accessed online Jan. 10, 2020.
  12. Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin Oncol. 2019;37(suppl; abstr 9013).
  13. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;14;355(24):2542-2550.

Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene
press@guardanthealth.com

Julie Johnson
julie.johnson@uncappedcommunications.com

Source: Guardant Health, Inc.



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