On May 26, 2023 Foundation Medicine, Inc., reported that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6 in Chicago (Press release, Foundation Medicine, MAY 26, 2023, View Source [SID1234632159]).
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Informing outcomes through ctDNA monitoring
Circulating tumor DNA (ctDNA) has emerged as a promising tool to support oncologists in monitoring their advanced cancer patients’ response to therapy. Two studies being presented at ASCO (Free ASCO Whitepaper) further define the clinical application of ctDNA monitoring and demonstrate the value of FoundationOneTracker to support and inform oncologists’ treatment planning.
Circulating tumor DNA (ctDNA) monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel (Abstract 9075)
Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo) (Abstract 9022)
New Capabilities of Liquid Biopsy
Several studies to be presented by Foundation Medicine at ASCO (Free ASCO Whitepaper) demonstrate the unique capabilities of the company’s FDA-approved liquid biopsy comprehensive genomic profiling (CGP) test, FoundationOneLiquid CDx. Foundation Medicine is unique in its ability to report ctDNA tumor fraction in clinical reports for more confident clinical decision making, and along with its collaborators, is presenting two studies highlighting the clinical utility and differentiating factors of FoundationOne Liquid CDx’s tumor fraction reporting. Foundation Medicine will also present new data describing FoundationOne Liquid CDx’s robust ctDNA-based detection of rearrangements and fusions. It is the only company with companion diagnostics for fusions on both its tissue and blood-based CGP tests, and this research at ASCO (Free ASCO Whitepaper) continues to demonstrate the clinical utility of FoundationOne Liquid CDx’s regulatory-grade fusion detection and bioinformatics.
Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC) (Abstract 9076)
The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP (Abstract 9035)
Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies (Abstract 4085)
Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract 5056)1
Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) (Abstract 9082)
Driving innovation through development and validation of complex genomic biomarkers
Multiple lines of evidence, including what will be communicated in an oral presentation, demonstrate the validity and utility of Foundation Medicine’s complex genomic biomarkers, including tumor mutational burden (TMB) and a signature for homologous recombination deficiency (HRDsig).
Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types (Abstract 2503)
Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness (Abstract 4146)
Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study (Abstract 1036)
HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC) (Abstract 539)
Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice (Abstract 5583)
Addressing inequities in next generation sequencing for patients with NSCLC
Additionally, in partnership with The West Cancer Center, OneOncology, Flatiron Health and Genentech, a member of the Roche Group, there will be an oral presentation of joint research examining inequities in next generation sequencing (NGS) testing for patients with advanced non-small cell lung cancer being treated in the community setting in the United States.
Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients (Abstract 6508)
"Our data at ASCO (Free ASCO Whitepaper) demonstrates the expanded and differentiated capabilities of our monitoring and liquid biopsy tests, reinforces our leadership in detection of complex genomic biomarkers, and supports increased confidence and ease in our tests’ use by doctors and researchers," says Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "Much of this research was conducted in collaboration with our partners across the oncology ecosystem, underscoring our commitment to working together in order to make faster, more impactful progress for patients."
The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at ASCO (Free ASCO Whitepaper), please visit ASCO (Free ASCO Whitepaper).org.
Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ASCO23 and visit us in person at Booth #19081.
Abstract #
Title
Collaborators
Product
Orals
2503
Sunday, June 4
9:45 AM – 12:45 PM
Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types
UC Davis Comprehensive Cancer Center, Flatiron Health and others
Foundation Medicine and Flatiron Health’s Joint Clinico-Genomic Database (CGDB)
6508
Tuesday, June 6
8:00 – 11:00 AM
Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients
The West Cancer Center, OneOncology, Genentech Inc., Flatiron Health, Tennessee Oncology
Flatiron Health Database
Poster Discussions
9022
Sunday, June 4
4:30 – 6:00 PM
Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo)
Third-party poster generated by Regeneron Pharmaceuticals, Inc., MD Anderson Cancer Center and others featuring results obtained through collaboration with Foundation Medicine, Natera Inc., and others
FoundationOneTracker
Posters
5056
Saturday, June 3
8:00 – 11:00 AM
Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer)
Peter MacCallum Cancer Centre, Institute Gustave Roussy, Pfizer and others
FoundationOneCDx
FoundationOneLiquid CDx
11541
Saturday, June 3
1:15 – 4:15 PM
Clinical Utility of Liquid-based Comprehensive Genomic Profiling (CGP) in Gastrointestinal Stromal Tumors (GIST)
Boston University Medical Campus, OHSU Knight Cancer Institute, Boston Medical Center
FoundationOneCDx
FoundationOneLiquid CDx
TPS3166
Saturday, June 3
8:00 – 11:00 AM
SPARK, Studying Pathways of Resistance in KRAS-driven Cancers: A remote plasma ctDNA participation study to identify mechanisms of resistance to KRAS inhibitors
Dana-Farber Cancer Institute, Lowe Center for Thoracic Oncology, KRAS Kickers, GO2 Foundation for Lung Cancer, Addario Lung Cancer Medical Institute, Bonnie J Addario Lung Cancer Foundation, Addario Lung Cancer Medical Institute (ALCMI)
FoundationOneLiquid CDx
9587
Saturday, June 3
1:15 – 4:15 PM
Comprehensive Genomic Profiling (CGP) of Clinically Advanced and Metastatic Cutaneous Adnexal Carcinomas (CAs; MCADCA): A Genomic Landscape Study
SUNY Upstate Medical University, Upstate University Hospital
FoundationOneCDx
5044
Saturday, June 3
8:00 – 11:00 AM
Penile Squamous Cell Carcinoma (PSCC) with Elevated Tumor Mutational Burden (TMB): A Genomic Landscape Study
SUNY Upstate Medical University, H. Lee Moffitt Cancer Center and Research Institute, University of Washington; Fred Hutchinson Cancer Center, The University of Texas MD Anderson Cancer Center, Vita-Salute San Raffaele University
FoundationOneCDx
4587
Saturday, June 3
8:00 – 11:00 AM
CDH1-Mutated Clinically Advanced Urothelial Bladder Cancer (UBC): A Genomic Landscape and Real-World Clinical Outcome Study (RWCOS)
Moffitt Cancer Center and Research Institute, Vita-Salute San Raffaele University, Saint Louis University Hospital, University of Washington; Fred Hutchinson Cancer Center, SUNY Upstate Medical University
FoundationOneCDx
CGDB
9075
Sunday, June 4
8:00 – 11:00 AM
Circulating Tumor DNA (ctDNA) Monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel
H. Lee Moffitt Cancer Center and Research Institute, Natera, Inc., Genentech Inc., AdventHealth Cancer Institute
FoundationOneTracker
9076
Sunday, June 4
8:00 – 11:00 AM
Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC)
Icahn School of Medicine at Mount Sinai, UC San Diego Moores Cancer Center
FoundationOneCDx
FoundationOneLiquid CDx
CGDB
9082
Sunday, June 4
8:00 – 11:00 AM
Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA)
Third-party poster generated by Takeda Pharmaceuticals USA and others featuring FoundationOneLiquid CDx results obtained through collaboration with Foundation Medicine
FoundationOneLiquid CDx
9035
Sunday, June 4
8:00 – 11:00 AM
The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP
Mount Sinai Health System and others
FoundationOneCDx
FoundationOneLiquid CDx
9094
Sunday, June 4
8:00 – 11:00 AM
Characterization of diverse targetable alterations in ERBB2 and ERBB3 in 93,465 non-small cell lung cancers (NSCLC)
Memorial Sloan Kettering Cancer Center, University of California San Diego, Moores Cancer Center
FoundationOneCDx
FoundationOneLiquid CDx
539
Sunday, June 4
8:00 – 11:00 AM
HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC)
Yale School of Medicine, Yale Cancer Center
CGDB
1036
Sunday, June 4
8:00 – 11:00 AM
Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study
Lifespan Health System, Ohio State University Comprehensive Cancer Center, SUNY Upstate Medical University, Upstate University Hospital, Yale Cancer Center, Yale School of Medicine
FoundationOneCDx
4085
Monday, June 5
8:00 – 11:00 AM
Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies
Weill Cornell Medicine, Englander Institute of Precision Medicine, New York Presbyterian Hospital, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center
FoundationOneCDx
FoundationOneLiquid CDx
4146
Monday, June 5
8:00-11:00 AM
Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness
University Hospital Seidman Cancer Center, Case Western Reserve University, Mayo Clinic
FoundationOneCDx
CGDB
5593
Monday, June 5
1:15 – 4:15 PM
Gynecologic-Cancer Analysis of ARID1A Alterations Detected in Both Tissue and Liquid Biopsies
National Cancer Institute
FoundationOneCDx
FoundationOneLiquid CDx
5583
Monday, June 5
1:15 – 4:15 PM
Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice
Stephenson Cancer Center/University of Oklahoma Health Sciences Center and Sarah Cannon Research Institute, University of Oklahoma, Flatiron Health
FoundationOneCDx
CGDB
4088
Monday, June 5
8:00 – 11:00 AM
ASCO Merit Award
Characterizing KRAS Allele Variants Within Biliary Tract Cancers
Princess Margaret Cancer Centre, MD Anderson Cancer Center University Health Network, University of Toronto, SUNY Upstate Medical University
FoundationOneCDx