Data at AACR Demonstrate Growing Clinical Utility of Guardant Health Liquid Biopsies in the Treatment and Management of Advanced Cancers

Rhea-AI Summary

Guardant Health (Nasdaq: GH) presents significant findings at the AACR Virtual Annual Meeting, showcasing the effectiveness of its blood tests in precision oncology. Key data support the utility of Guardant360®, Guardant360 CDx, and GuardantOMNI™ in detecting actionable mutations and informing treatment pathways for cancer patients. The Guardant360 CDx has been validated for use with Amgen’s KRAS G12C inhibitor, sotorasib. Notably, the tests demonstrate high concordance with tissue biopsies, enhancing access to critical diagnostics. These advancements aim to improve treatment outcomes, particularly as healthcare recovers from the pandemic.

Positive

• Guardant360 CDx validated for use with Amgen's sotorasib, enhancing treatment selection for KRAS G12C patients.
• High concordance shown between blood and tissue biopsies, expanding access to diagnostics.
• The ability of Guardant360 CDx to operate with low input levels may increase patient samples for decision-making.

Negative

• None.

Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, presents new data at the AACR Virtual Annual Meeting I, April 10-15, 2021, highlighting the use of the company’s proprietary blood tests to advance precision oncology.

Key findings demonstrate the value of Guardant360^®, Guardant360 CDx, and GuardantOMNI™ liquid biopsy tests to detect clinically actionable mutations, inform treatment for patients as their cancer progresses, and reveal tumor evolution and resistance in response to interventional therapies, including immunotherapies.

“At this year’s AACR, we highlight the growing clinical utility of our liquid biopsy tests, from revealing critical genomic and molecular insights that contribute to vitally important drug development efforts, to further informing treatment decisions as patients with advanced disease progress,” said Helmy Eltoukhy, Guardant Health CEO. “As we exit the pandemic, the ability to effectively treat advanced cancers that may have remained undetected during the past year will be critical, and there is no room for error or further delays in finding the right treatment or clinical trial. Now more than ever, our liquid biopsies are needed to accelerate the accessibility of effective treatment options for patients most in need of precise clinical therapies.”

Guardant360 CDx validated for use with Amgen’s investigational KRAS^G12C inhibitor, sotorasib

Data from the phase 2 CodeBreaK 100 trial evaluating investigational sotorasib in patients with advanced non-small cell lung cancer (NSCLC) showed the objective response rate was comparable in patients selected using Guardant360 CDx liquid biopsy or tissue biopsy, with high concordance demonstrated between the two assays.

“The study results highlight that the Guardant360 blood-based companion diagnostic test was effective at selecting patients with KRAS G12C who may benefit from treatment with sotorasib, said Darryl Sleep, senior vice president, global medical and chief medical officer, Amgen. “KRAS G12C can only be detected with a biomarker test and with one in eight patients with NSCLC harboring the KRAS G12C mutation, there is a critical need to improve access to high quality diagnostics and more routine screening.”

Title	Clinical validation of plasma cell-free DNA (cfDNA) sequencing in the phase 2 trial of sotorasib in patients (pts) with KRAS p.G12C mutated NSCLC
Abstract No.	CT181
Session	Phase II Clinical Trials
Date / Time	e-Poster Presentation: April 10, 2021, 8:30 AM – 11:59 PM EDT

Guardant360 CDx delivers results at low inputs, which can potentially increase patient samples for clinical decision-making and clinical studies

Study shows Guardant360 CDx provides comprehensive tumor profiling results with robust analytical performance at demonstrated low inputs (5ng cutoff). These data suggest that Guardant360 CDx has the potential to guide therapy decisions for about 34% more patients compared to some liquid biopsies that use 2 blood collection tubes (BCT) for minimal 30ng of cell-free DNA (cfDNA). The data also show that the ability to process samples below 15ng input from a single BCT increases the yield of EGFR driver mutations by >25%. Furthermore, because retrospective studies are often performed with as little as 2mL of plasma, the study shows that the Guardant360 CDx is expected to return valid results on over 88% of such samples, which may be outside the performance specifications for other assays.

FAQ

What did Guardant Health present at the AACR Virtual Annual Meeting 2021?

Guardant Health presented data supporting its blood tests' effectiveness in precision oncology, including the validation of Guardant360 CDx with Amgen's sotorasib.

How does Guardant360 CDx impact cancer treatment decisions?

Guardant360 CDx helps in selecting patients who may benefit from specific treatments, improving access to effective therapies.

What are the benefits of using Guardant360 CDx over traditional biopsies?

Guardant360 CDx shows high concordance with tissue biopsies and requires less blood, potentially increasing patient sample accessibility for testing.

What specific cancer mutation does Guardant360 CDx test for in relation to sotorasib?

Guardant360 CDx tests for the KRAS G12C mutation, which is crucial for selecting patients suitable for sotorasib treatment.

When did Guardant Health present their findings at the AACR meeting?

Guardant Health presented their findings on April 10, 2021, during the AACR Virtual Annual Meeting.