Guardant Health Announces Collaboration With Daiichi Sankyo to Develop Guardant360® CDx as a Companion Diagnostic for Enhertu® in Advanced Metastatic Non-Small Cell Lung Cancer

Rhea-AI Summary

Guardant Health announces a collaboration with Daiichi Sankyo to seek regulatory approval for the Guardant360 CDx blood test as a companion diagnostic for Enhertu, targeting HER2 mutations in patients with advanced non-small cell lung cancer (NSCLC). This partnership aims to address unmet medical needs, enhancing patient outcomes with personalized medicine. The Guardant360 CDx test, already FDA-approved, offers comprehensive genomic profiling, crucial for guiding treatment decisions across solid tumors.

Positive

• Collaboration with Daiichi Sankyo aims to enhance treatment options for NSCLC patients.
• Guardant360 CDx is FDA-approved and facilitates comprehensive genomic profiling.

Negative

• None.

Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Daiichi Sankyo, Inc. (Daiichi Sankyo) to pursue regulatory approval and commercialization of the Guardant360^® CDx blood test as a companion diagnostic for Enhertu^® (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody-drug conjugate (ADC), being studied in the treatment of patients with advanced metastatic non-small cell lung cancer (NSCLC).

“For patients with metastatic non-small cell lung cancer, personalized medicines targeting actionable mutations, as revealed by our Guardant360 liquid biopsy test, have been life-changing,” said Helmy Eltoukhy, Guardant Health CEO. “Such medicines may extend overall survival for many patients, and we are excited to work with Daiichi Sankyo, as there remains an unmet medical need to help non-small cell lung cancer patients with HER2 mutations.”

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results to guide treatment in all solid tumors, including NSCLC. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of treatment-relevant genomic alterations continues to grow.

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 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.

Source: Guardant Health, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210427005136/en/

FAQ

What is the collaboration between Guardant Health and Daiichi Sankyo about?

Guardant Health is collaborating with Daiichi Sankyo to pursue regulatory approval for the Guardant360 CDx blood test as a companion diagnostic for Enhertu in advanced non-small cell lung cancer.

What does the Guardant360 CDx blood test do?

The Guardant360 CDx test provides comprehensive genomic profiling to guide treatment in all solid tumors, including advanced non-small cell lung cancer.

How does the Guardant360 CDx test benefit NSCLC patients?

It helps identify actionable mutations in NSCLC patients, potentially leading to personalized treatment strategies that can enhance overall survival.

What type of cancer is the focus of this collaboration?

The collaboration focuses on advanced metastatic non-small cell lung cancer (NSCLC) patients with HER2 mutations.

When was the collaboration between Guardant Health and Daiichi Sankyo announced?

The collaboration was announced today by Guardant Health.