Late breaking results from the CUPISCO study demonstrate how molecularly guided treatment using Foundation Medicine testing positively impacted survival in patients with cancer of unknown primary origin (CUP)

New research reinforces the unique capabilities of FoundationOne®Liquid CDx’s ctDNA tumor fraction algorithm to further validate confidence in liquid biopsy

Study reveals genetic differences between ancestries in patients with biliary tract cancer (BTC)

Foundation Medicine, Inc., today announced that the company will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting from October 20-24 in Madrid, Spain.

Late Breaking Results from the CUPISCO Study

In a late-breaking abstract, Foundation Medicine and Roche share results from the randomized precision oncology study, CUPISCO, designed to prospectively assess the efficacy of molecularly guided therapy for patients with unfavorable subset cancer of unknown primary (CUP). In patients with CUP, the tumor of origin is unknown, which has historically made targeted treatment challenging. As a result, there has been little progress in improving the poor outcomes for these patients. The study demonstrates how genomic profiling using Foundation Medicine’s FDA-approved FoundationOne®CDx and FoundationOne®Liquid CDx diagnostic tests positively impacted progression-free survival and overall survival in patients with CUP.

• Primary analysis of efficacy and safety in CUPISCO: A randomised, global study of targeted therapy or cancer immunotherapy guided by genomic profiling vs platinum-based chemotherapy (CTX) in patients (pts) with treatment-naive, unfavourable carcinoma-of-unknown-primary-origin (CUP) (Proffered Paper Session 1, LBA16)

Highlighting Expanded Capabilities of ctDNA Tumor Fraction

Research continues to validate the power of circulating tumor DNA (ctDNA) tumor fraction, which is a measurement of the level of ctDNA within a liquid biopsy sample, to support the interpretation of liquid biopsy test results. Two new studies being presented by Foundation Medicine and its collaborators at ESMO highlight the differentiated ctDNA tumor fraction reporting capabilities of the company’s FoundationOne®Liquid CDx test. The research explores ctDNA tumor fraction’s correlation with metabolic tumor volume on with a PET scan, and its prognostic use in bladder cancer, respectively.

• Clinical and genomic correlates of plasma circulating tumor DNA (ctDNA) tumor fraction (TF) in patients with advanced NSCLC (Presentation Number 2339P)
• Relationship of Tumor Fraction in Circulating Tumor DNA (ctDNA) with Prognosis in Patients with Advanced Urothelial Cancer (Presentation Number 2396P)

Demonstrating Differences in Genetic Ancestry in Biliary Tract Cancer

Molecular differences between genetic ancestries in patients with biliary tract cancer (BTC) and the impact of those differences on prognosis and treatment response are largely unknown. In a study conducted with The University of Texas MD Anderson Cancer Center, researchers looked at over 10,000 cases of BTC in patients of African and European descent and identified key clinical and genomic differences.

• Molecular Profiling of Biliary Tract Cancer (BTCs) in Patients of African and European ancestries​ (Presentation Number 113P)
  
  

“The research we are presenting at this year’s ESMO reinforces the ever-expanding clinical utility across disease types of our high-quality tissue and blood-based tests,” says Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “Alongside our collaborators, we’re proud to share our continued progress in bringing more knowledge and cancer treatment options to the cancer community.”

The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at ESMO, please visit ESMO.org.

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ESMO23 and visit us in person at Booths 727 and 728.

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.

Source: Foundation Medicine

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