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Foundation Medicine and Its Collaborators Announce Acceptance of 21 Abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
2023-05-26
临床3期ASCO会议免疫疗法
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., today announced 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) Annual Meeting from June 2-6 in Chicago.
'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.'
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 further define the clinical application of ctDNA monitoring and demonstrate the value of FoundationOne®Tracker 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 demonstrate the unique capabilities of the company’s FDA-approved liquid biopsy comprehensive genomic profiling (CGP) test, FoundationOne®Liquid 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 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) 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 CenterCancer 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 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, please visit ASCO.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
UC Davis Comprehensive Cancer CenterCancer 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 CenterCancer Center and others featuring results obtained through collaboration with Foundation Medicine, Natera Inc., and others
FoundationOne®Tracker
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
FoundationOne®CDx
FoundationOne®Liquid 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 InstituteCancer Institute, Boston Medical Center
FoundationOne®CDx
FoundationOne®Liquid 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 inhibitorsKRAS inhibitors
Dana-Farber Cancer InstituteCancer Institute, Lowe Center for Thoracic Oncology, KRAS Kickers, GO2 Foundation for Lung Cancer, Addario Lung Cancer Medical InstituteLung Cancer Medical Institute, Bonnie J Addario Lung Cancer Foundation, Addario Lung Cancer Medical Institute (ALCMI)Lung Cancer Medical Institute (ALCMI)
FoundationOne®Liquid 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
FoundationOne®CDx
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 InstituteCancer Center and Research Institute, University of Washington; Fred Hutchinson Cancer Center, The University of Texas MD Anderson Cancer Center, Vita-Salute San Raffaele University
FoundationOne®CDx
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
FoundationOne®CDx
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 InstituteCancer Institute
FoundationOne®Tracker
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)
FoundationOne®CDx
FoundationOne®Liquid 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 FoundationOne®Liquid CDx results obtained through collaboration with Foundation Medicine
FoundationOne®Liquid 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
FoundationOne®CDx
FoundationOne®Liquid 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
FoundationOne®CDx
FoundationOne®Liquid 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)
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 CenterCancer Center, SUNY Upstate Medical University, Upstate University Hospital, Yale Cancer CenterCancer Center, Yale School of Medicine
FoundationOne®CDx
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
FoundationOne®CDx
FoundationOne®Liquid 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
FoundationOne®CDx
CGDB
5593
Monday, June 5
1:15 – 4:15 PM
Gynecologic-Cancer Analysis of ARID1A Alterations Detected in Both Tissue and Liquid Biopsies
FoundationOne®CDx
FoundationOne®Liquid 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
FoundationOne®CDx
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
FoundationOne®CDx
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.
About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
__________________________
1 FoundationOne®Liquid CDx is not FDA-approved as a companion diagnostic for talazoparib.
Source: Foundation Medicine
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