Press Release

May 5, 2020

Guardant Health and Patient Advocacy Groups Join Forces to Raise Awareness of the Importance of Complete Biomarker Testing for Patients with Metastatic Non-Small Cell Lung Cancer

Incomplete testing fails to meet current medical guideline standards, placing more than 80 percent1 of patients at increased risk of receiving a less effective treatment

REDWOOD CITY, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) has launched the Clear Your View campaign to raise awareness of the important role complete biomarker testing plays in guiding initial treatment decisions for newly diagnosed advanced non-small cell lung cancer (NSCLC) patients. Current medical guidelines call for testing all 10 tumor biomarkers in advanced NSCLC.

The campaign encourages oncologists to “stop, test, and wait” for complete biomarker testing results before starting initial treatment. The campaign is supported by several national patient advocacy groups, including GO2 Foundation for Lung Cancer, LUNGevity Foundation, and ALK Positive. Complete biomarker testing is especially critical given the logistical challenges imposed by the COVID-19 pandemic to ensure that each and every patient is matched with an effective therapy upfront, since targeted therapy options, if appropriate, are often easier or more convenient to administer.

“Receiving the right initial treatment can mean the difference between slowing disease progression, and potentially extending survival,” said Bonnie J. Addario, Co-Founder, Board Chair, GO2 Foundation for Lung Cancer. “While great progress has been made in treating advanced lung cancer, studies show that fewer than 20 percent of patients receive comprehensive guideline-recommended biomarker testing. We must make sure that patients receive the benefit from treatment advances through biomarker testing that matches them to the right therapy.”

Clinical studies show that patients receiving targeted or personalized treatments have improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.2-8  Various factors contribute to clinical adoption of personalized medicine lagging behind recommended medical guidelines.1,9-11 Physicians report rapidly changing medical guidelines and the approval of new therapies create an increasingly complex treatment landscape. In addition, patients and physicians want to start treatment as soon as possible. Finally, insurers have been slow to put coverage in place for complete biomarker testing, which may influence the oncologist’s decision on what biomarker tests to order.

“Through the Clear Your View campaign we hope to raise awareness amongst physicians of the clear benefits of complete biomarker testing for patients with NSCLC,” said Helmy Eltoukhy, Guardant Health CEO. “This campaign calls attention to the risk undergenotyping can have on patient outcomes and the need for complete biomarker testing. Indeed, in this difficult time period, it has never been more critical to match patients with the right therapy the first time.”

Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25 percent of all cancer deaths.12  Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.12

The campaign is being delivered to over 10,000 oncologists nationwide. The campaign website can be found here.

About ALK Positive Organization
We are a patient-driven group, providing information, support, empathy, and research funding to change the future of ALK-Positive lung cancer. ALK Positive consists of 1,800+ ALK-positive lung cancer patients and their caregivers in 42+ countries. Through our foundational online support group, we are able to support each other worldwide and share information to become empowered patients-advocates. https://www.alkpositive.org/treatment-options

About GO2 Foundation for Lung Cancer
Founded by patients and survivors, GO2 Foundation for Lung Cancer (formerly the Bonnie J. Addario Lung Cancer Foundation and Lung Cancer Alliance), transforms survivorship as the world's leading organization dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. Through our LungMATCH program patients can access free individualized guidance, including referrals for biomarker testing and discussions on treatment and clinical trial options. www.go2foundation.org.

About LUNGevity Foundation
LUNGevity is the nation's leading lung cancer organization investing in lifesaving, translational research and providing free support services and education for patients and caregivers. LUNGevity’s Take Aim Initiative is focused on increasing patient and provider awareness about biomarker testing.  https://lungevity.org/for-patients-caregivers/lung-cancer-101/diagnosing-lung-cancer/biomarker-testing

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 launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, 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 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. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, and in its other reports filed with the Securities and Exchange Commission, including in its Quarterly Report on Form 10-Q for the period ended March 31, 2020, when filed. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, 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. 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:

Carrie Mendivil
investors@guardanthealth.com

Media Contacts:

Anna Czene
press@guardanthealth.com

Becky Lauer
becky.lauer@uncappedcommunications.com

References:

  1. 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.
  2. 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.
  3. 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.
  4. 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(28):2518-2527.
  5. 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.
  6. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/ Accessed online Jan. 10, 2020.
  7. 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).
  8. 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.
  9. Carter GC, Landsman-Blumberg PB, Johnson BH, et al. KRAS testing of patients with metastatic colorectal cancer in a community-based oncology setting: a retrospective database analysis. J Exp Clin Cancer Res. 2015; 34:29.
  10. Charlton ME, Kahl AR, Greenbaum AA, et al. KRAS Testing, Tumor Location, and Survival in Patients With Stage IV Colorectal Cancer: SEER 2010–2013. J Natl Compr Canc Netw. 2017;15(12):1484-1493.
  11. 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 2019.
  12. American Cancer Society, Accessed online https://www.cancer.org/latest-news/facts-and-figures-2020.html. March 10, 2020.

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Source: Guardant Health, Inc.