New research demonstrates the emerging applications of Foundation Medicine’s liquid biopsy and monitoring portfolio

Additional research investigates new biomarkers and highlights the expanding utility of comprehensive genomic profiling (CGP), including RNA sequencing

Foundation Medicine, Inc., today announced that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.

Emerging Applications of Liquid Biopsy Using FoundationOne®Liquid CDx and FoundationOne®Tracker

  • Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer (Abstract #1042)
  • Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO (Abstract #TPS3644)
  • Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract #5020)
  • Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC) (Abstract #5085)
  • BRCA1/2 reversion mutations (BRCArev) in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy (Abstract #5056)

Utility of CGP in Earlier Stages of Disease, Rare Cancers, and Using RNA Sequencing

  • Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial (Abstract #8068)
  • Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel (Abstract #5091)
  • On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers (Abstract #3127)
  • New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction (Abstract #11545)

New CGP Biomarkers, Including Homologous Recombination Deficiency (HRD) Signature and Methyl Thioadenosine Phosphorylase (MTAP) Genomic Loss

  • Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx) (Abstract #591)
  • Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors (Abstract #3129)
  • Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors (Abstract #3067)
  • Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): Co-occurrence and prevalence along treatment course (Abstract #1060)

Impact of Ancestry on the Genomic Alteration Landscape

  • Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC) (Abstract #4138)
  • Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes (Abstract #5614)

“Our data at this year’s ASCO annual meeting reflects Foundation Medicine’s progress in making genomic profiling indispensable to cancer care and research, particularly in lung, breast and prostate cancers where there is an increasing number of targeted therapies for health care providers to consider for these patients,” says Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. “We are also excited to demonstrate our new RNA sequencing capabilities and spotlight the expanding utility of ctDNA to inform treatment decision making through a simple blood sample.”

The following is a complete list of Foundation Medicine abstracts that will be presented. To access the abstracts being presented at ASCO, please visit ASCO.org/abstracts.

Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO24 and visit us in person at Booth #22031.

Abstract #

Title

Collaborator

Products

Posters

Abstract #3127 6/1/2024 9:00 AM- 12:00 PM

On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers

TargetCancer Foundation, UC San Diego Moores Cancer Center, University of California, San Diego, Medical College of Wisconsin (MCW) Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins Hospital, The University of Texas MD Anderson Cancer Center, Department of Pharmacy, Rutgers New Jersey Medical School, Medication Acquisition, Inc., Sarah Cannon Research Institute, University of Nebraska, WIN Consortium for Precision Medicine

FoundationOne®CDx FoundationOne®Liquid CDx

Abstract #3129 6/1/2024 9:00 AM- 12:00 PM CDT

Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors

Memorial Sloan Kettering Cancer Center

FoundationOne®CDx FoundationOne®Liquid CDx

Abstract #4138 6/1/2024 1:30 PM- 4:30 PM CDT

Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC)

Yale Cancer Center, New York University Perlmutter Cancer Center

FoundationOne®CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract #TPS3644 6/1/2024 1:30 PM- 4:30 PM CDT

Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO

University of Pisa, Italy

FoundationOne®Tracker

Abstract #11545 6/1/2024 1:30 PM- 4:30 PM CDT

New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction

Universitario Lisboa Norte, Institute Portugues de Oncologia de Lisboa Francisco Gentil, Institute Superior Tecnico, Universidade de Lisboa, Institute de Medicina Molecular Joao Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, F. Hoffmann-La Roche AG, Institute Superior Tecnico (1ST), Universidade de Lisboa, Hospital CUF Descobertas

FoundationOne®RNA for research use

Abstract #3067

6/1/2024 9:00 AM- 12:00 PM CDT

Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors

San Raffaele Hospital and Scientific Institute, Italy

FoundationOne® FoundationOne®CDx

Abstract #1060 6/2/2024 9:00 AM- 12:00 PM CDT

Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): co-occurrence and prevalence along treatment course

Emory University

FoundationOne®CDx FoundationOne®Liquid CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract #591 6/2/2024 9:00 AM- 12:00 PM CDT

Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx)

Stanford University

FoundationOne®CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract #5056 6/2/2024 9:00 AM- 12:00 PM CDT

BRCA1/2 reversion mutations in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy

Cedars-Sinai Medical Center, Upstate University Medical Center, University of California - San Diego

FoundationOne®Liquid CDx

Abstract #1042 6/2/2024 9:00 AM- 12:00 PM CDT

Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer

Johns Hopkins University School of Medicine, Vanderbilt University Medical Center, Allegheny Health Network, Weill Cornell Medicine and New York-Presbyterian Hospital

FoundationOne®Liquid CDx

 

Abstract #5091 6/2/2024 9:00 AM- 12:00 PM CDT

Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel

Huntsman Cancer Institute, Masonic Cancer Center

Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB)

Abstract #5085 6/2/2024 9:00 AM- 12:00 PM CDT

Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC)

Rogel Comprehensive Cancer Center, University of Michigan, Karmanos Cancer Institute, Wayne State University

FoundationOne®Liquid CDx

 

Abstract #5020 6/2/2024 9:00 AM- 12:00 PM CDT

Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Peter MacCallum Cancer Centre, Department of Medical Oncology, Institut Gustave Roussy, University of Paris-Saclay, Pfizer Inc., National Cancer Center Hospital East, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, The Urology Center of Colorado, National Cancer Center, Tom Baker Cancer Centre, University of Calgary, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Huntsman Cancer Institute (NCI-CCC), University of Utah

FoundationOne®Liquid CDx FoundationOne®Monitor for Research Use

Abstract #3626 6/2/2024 9:00 AM- 12:00 PM CDT

Contrasting comprehensive genomic profiles of adenocarcinomas of the appendix in younger versus older patients

Upstate Medical University

FoundationOne® FoundationOne®CDx

Abstract #4588 6/2/2024 9:00 AM- 12:00 PM CDT

FGFR3-mutated urothelial carcinoma of bladder and upper tract including ureter and renal pelvis: A comparative genomic profiling study

Upstate Medical University, University of California – Los Angeles, University of Washington, Huntsman Cancer Center, Moffitt Cancer Center, MD Anderson Cancer Center, Cleveland Clinic, San Rafael University

FoundationOne® FoundationOne®CDx

 

Abstract #8032 6/2/2024 9:00 AM- 12:00 PM CDT

Retrospective analysis of change in frequency of STK11 mutation in lung adenocarcinomas over a 10-year period

Upstate Medical University

FoundationOne® FoundationOne®CDx

 

Abstract #1092 6/2/2024 9:00 AM- 12:00 PM CDT

Impact of HER2 low status on genomic signatures in triple negative breast cancer (TNBC)

Yale University

FoundationOne® FoundationOne®CDx

 

Abstract #11575 6/2/2024 9:00 AM- 12:00 PM CDT

Intimal sarcomas (ISarc) of the cardiac chambers (CC) of the heart and great vessels (GV): A comprehensive genomic profiling (CGP) study

Upstate Medical University

FoundationOne® FoundationOne®CDx

 

Abstract #6036 6/2/2024 9:00 AM- 12:00 PM CDT

Clinical, molecular, and immunologic profiling of brain metastases (BM) in head and neck squamous cell carcinoma (HNSCC)

Dana-Farber Cancer Institute, University of California – San Diego, Phase Genomics

 

Abstract #5614 6/3/2024 9:00 AM- 12:00 PM CDT

Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes

University of Colorado Health, Mount Sinai

FoundationOne®CDx

Abstract #8068 6/3/2024 1:30 PM- 4:30 PM CDT

Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial

Baylor College of Medicine, Harvard University, University of Michigan, University of Missouri, University of Washington, University of California – Los Angeles, University of Colorado, Memorial Sloan Kettering

FoundationOne®CDx FoundationOne®Liquid CDx

Abstract #8532 6/3/2024 1:30 PM- 4:30 PM CDT

Molecular profiling across histologies in lung cancer: Time to change WHO nomenclature?

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, Papardo Hospital, Roche Sequencing Solutions

FoundationOne®CDx

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

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 LinkedIn and X.

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.

About FoundationOne®Tracker

FoundationOne®Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. FoundationOne Tracker is performed exclusively as a laboratory service and has not been cleared or approved by the U.S. Food and Drug Administration. For technical specifications, please visit FoundationMedicine.com.

About FoundationOne®RNA

FoundationOne®RNA is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne RNA has not been cleared or approved by the U.S. Food and Drug Administration. FoundationOne RNA is a test for solid tumors which utilizes RNA sequencing to interrogate 318 cancer-related genes to capture gene fusions and rearrangements. A negative result does not rule out the presence of an alteration. Genomic findings are not prescriptive or conclusive for labeled use of any specific therapeutic product.

Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com