On April 10, 2021 Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, reported new data at the AACR (Free AACR Whitepaper) Virtual Annual Meeting I, April 10-15, 2021, highlighting the use of the company’s proprietary blood tests to advance precision oncology (Press release, Guardant Health, APR 10, 2021, View Source [SID1234577868]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (Free AACR Whitepaper), 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 KRASG12C 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.
Title
The liquid biopsy Guardant360 CDx has robust performance at low inputs allowing for high rate of returning patient results
Abstract No.
572
Session
Liquid Biopsies: Circulating DNA
Date / Time
April 10, 2021, 8:30 AM – 11:59 PM EDT
Studies show Guardant360 provides early indication of treatment response and resistance mechanisms in the management of advanced cancer
Data presented are consistent with prior studies, across various treatments and indications,1-10 showing Guardant360 provides early indication of treatment response and clinical outcomes by measuring molecular response or changes to circulating tumor DNA from baseline at different time-points. In addition, data presented show that Guardant360 can also reveal tumor evolution and resistance in response to interventional therapies, including immunotherapies.
Title
Reversion patterns in homologous recombination repair genes in metastatic cancer patients profiled by cell-free DNA
Abstract No.
25
Session
Biomarkers
Date / Time
MINISYMPOSIUM PRESENTATION
April 10, 2021, 2:20 PM – 2:30 PM EDT
Title
Comparison of molecular response calculations for prediction of patient outcome
Abstract No.
401
Session
Biomarkers Predictive of Therapeutic Benefit
Date / Time
Poster presentation: April 10, 2021, 8:30 AM – 11:59 PM EDT
Other abstracts and poster presentations
Title
Confirmation of Target Inhibition and Anti-Tumor Activity of the SHP2 Inhibitor RMC-4630 via Longitudinal Analysis of ctDNA in RAS-Addicted Tumors in a Phase 1 Clinical Study
Title
A single institution experience with Guardant360 liquid biopsy for therapeutic decision in advanced solid tumors
Title
NTRK1 fusion detection from clinical cfDNA NGS using a de novo fusion caller
Title
Detection of somatic copy number alterations from on-target and off-target sequencing data