On October 19, 2023 Foundation Medicine, Inc., reported 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) (Free ESMO Whitepaper) Annual Meeting from October 20-24 in Madrid, Spain (Press release, Foundation Medicine, OCT 19, 2023, View Source [SID1234636164]).

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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 FoundationOneCDx and FoundationOneLiquid 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 (Free ESMO Whitepaper) highlight the differentiated ctDNA tumor fraction reporting capabilities of the company’s FoundationOneLiquid 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 (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper), please visit ESMO (Free ESMO Whitepaper).org.

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

Abstract #

Title

Collaborators

Product

Proffered Paper (Oral)

LBA16

Saturday, October 21

10:35-10:45 a.m.

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)

Oncologists from Europe, Asia and Oceania, Central lab at University Hospital of Zurich

FoundationOneCDx

FoundationOneLiquid CDx

1182O

Sunday, October 22

9:20-9:30 a.m.

Temozolomide treatment induces an MMR-dependent hypermutator phenotype in well differentiated pancreatic neuroendocrine tumors

Hôpital Saint-Louis AP-HP

FoundationOneCDx

Posters

2352P

Sunday, October 22

Sex-Based Difference in Gene Alterations and Biomarkers in Anal Squamous Cell Carcinoma

IRCCS San Raffaele Scientific Institute

FoundationOneCDx

771P

Sunday, October 22

Genomic Characterization of Advanced Endometrial Carcinosarcoma: Identification of Potentially Actionable Targets

IRCCS Istituto Romagnolo per lo Studio dei Tumori, IRCCS San Raffaele Scientific Institute, IRCCS Istituto Nazionale Tumori

FoundationOneCDx

2339P

Sunday, October 22

Clinical and genomic correlates of plasma circulating tumor DNA (ctDNA) tumor fraction (TF) in patients with advanced NSCLC

Institut Gustave Roussy

FoundationOneLiquid CDx

113P

Monday, October 23

Molecular Profiling of Biliary Tract Cancer (BTCs) in Patients of African and European ancestries

MD Anderson

FoundationOneCDx

738P

Monday, October 23

Penile squamous cell carcinoma with high and very high tumor mutational burden: A genomic landscape and real-world clinical outcome study

Upstate Medical University, University of Washington, Moffit Cancer Center,

MD Anderson Cancer Center, San Rafael University

FoundationOneCDx

2396P

Monday, October 23

Relationship of Tumor Fraction in Circulating Tumor DNA (ctDNA) with Prognosis in Patients with Advanced Urothelial Cancer

Fox Chase Cancer Center, Temple University

FoundationOneLiquid CDx

1946P

Monday, October 23

Primary Sarcomas of the Urinary Bladder (BSar): A Genomic Landscape and Clinical Outcome Study

Upstate Medical University, University of Washington, Moffit Cancer Center, MD Anderson Cancer Center, San Rafael University

FoundationOneCDx

2395P

Monday, October 23

Micropapillary Histology (MPUC) and Extra-cellular Domain ERBB2 (ERBB2 ECD+) Mutations in Urothelial Bladder Cancer (UBC)

Upstate Medical University, University of Washington, Moffit Cancer Center, MD Anderson Cancer Center, San Rafael University

FoundationOneCDx

2400P

Monday, October 23

Frequency and Nature of Genomic Alterations (GA) in ERBB2-altered Urothelial Bladder Cancer (UBC)

Upstate Medical University, University of Washington, Moffit Cancer Center, MD Anderson Cancer Center, San Rafael University

On October 19, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in precision oncology, reported that a late-breaking abstract featuring data for the company’s NeXT Personal whole genome-based, tumor-informed assay for ultra-sensitive ctDNA detection, has been accepted and selected for a proffered paper presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, on October 21 in Madrid, Spain (Press release, Personalis, OCT 19, 2023, View Source [SID1234636163]).

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Presentation #LBA55

Title: "An ultra-sensitive and specific ctDNA assay provides novel pre-operative disease stratification in early stage lung cancer"
Location: Salamanca Auditorium – Hall 3
Date: October 21, 2023
Time: 10:15 – 10:25 CEST
Presenter: Dr. James R. Black MD, PhD, Francis Crick Institute

Late-breaking abstracts are typically reserved for high-quality, new research findings from randomized phase II or phase III trials with implications for clinical practice or understanding of disease processes. Proffered papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives.

On October 19, 2023 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that it will present data from DRAGON, a Phase 1 study of SRK-181 in patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego on November 1-5 (Press release, Scholar Rock, OCT 19, 2023, View Source [SID1234636162]). In one poster presentation, Scholar Rock will share preliminary biomarker data from Part B of the trial, and in a second poster presentation, provide safety, efficacy, and biomarker results of SRK-181 in anti-PD-1 resistant metastatic clear cell renal cell carcinoma (ccRCC) patients from both Parts A and B.

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"We are excited to present clinical and biomarker updates on the DRAGON study, which build upon the safety and efficacy data to date in the ccRCC cohort of the trial and support our goal of establishing the proof of mechanism of SRK-181," said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. "As a selective latent TGFβ1 inhibitor, SRK-181 has the potential to transform cancer immunotherapy by helping to overcome resistance to checkpoint inhibitor therapy. This investigational medicine demonstrates the promise of Scholar Rock’s unique discovery platform."

Details of the presentations are as follows:

Title: Establishing Proof of Mechanism in Patients: Preliminary Biomarker Data of SRK-181 (a latent TGFβ1 inhibitor) from DRAGON Study
Presentation Type: Poster 726
Presenter: Susan Henry, PhD, Senior Director, Translational Sciences, Scholar Rock, Inc.
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PDT and 7 – 8:30 PM PDT

Title: Safety, efficacy, and biomarker results of SRK-181, a latent TGFβ1 inhibitor, in anti-PD-1 resistant metastatic ccRCC patients
Presentation Type: Poster 666
Presenter: Timothy Yap, MBBS, PhD, FRCP, Medical Oncologist and Physician-Scientist; and Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PDT and 7 – 8:30 PM PDT

The abstracts for these presentations will be available on SITC (Free SITC Whitepaper)’s website on Oct 31, 2023: View Source

The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

For conference information, visit View Source

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (1) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The trial is currently enrolling and dosing patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On October 19, 2023 To support emerging precision therapies and improve patient outcomes by increasing access to reliable genomic testing needed to match patients with targeted cancer treatments, Thermo Fisher Scientific reported a companion diagnostic (CDx) partnership with Boehringer Ingelheim (Press release, Thermo Fisher Scientific, OCT 19, 2023, View Source [SID1234636161]). Through this collaboration, the companies will work to develop CDx tests to help identify patients with non-small cell lung cancer (NSCLC) with specific genomic mutations.

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Lung cancer is one of the most common cancers, with 2.2 million cases worldwide in 2020 and is the leading cause of cancer death in both Japani and the U.S.ii The collaboration will leverage the Oncomine Dx Express Test* on the Ion Torrent Genexus Dx System* as well as the Oncomine Dx Target Test.**

"Our proven track record of co-developing CDx tests reinforces our commitment to working with leading pharma companies to ensure patients may have immediate access to these targeted therapies once approved," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Boehringer Ingelheim has made a generational commitment to transforming cancer care, and we’re excited to be supporting their pipeline as they work to ensure the appropriate tests are available to match eligible patients with emerging targeted therapies."

Boehringer Ingelheim has the aspiration to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. By partnering with Thermo Fisher, Boehringer Ingelheim aims to develop multiple companion diagnostic tests to ensure that labs using a variety of testing technologies will have the ability to match eligible patients with emerging NSCLC treatments as they become available.

A recently published, real-world study in stage 4 NSCLC found that patients whose treatments were initiated before genomic insights were available experienced inferior outcomes, supporting the need for more rapid molecular testing.iii Thermo Fisher’s Oncomine Dx Express Test in combination with the Genexus Dx System offers a fully integrated, NGS platform that can test a patient’s tumor biopsy or blood specimen, returning actionable results in as little as 24 hours. The Genexus Dx System delivers a turnkey, end-to-end NGS system that requires as little as 10 minutes of hands-on time, simplifying the testing workflow and making this technology feasible for more labs.

The Oncomine Dx Target Test remains the only distributed NGS CDx kit that has received regulatory approval and is available in 18 countries worldwide for 17 targeted therapies.

*The Genexus Dx instrument and the Oncomine Dx Express Test are currently CE-IVD and only available to those countries who accept the CE-IVD mark.

**The Oncomine Dx Target Test is for In Vitro Diagnostic use

On October 19, 2023 Biological Dynamics, Inc., a leader in exosome-isolation technology for early disease detection, reported a newly published study in Nature’s Communications Medicine titled "Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma (Press release, Biological Dynamics, OCT 19, 2023, View Source [SID1234636160])." The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort.

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"Pancreatic cancer is one of the deadliest cancers and is often detected at a late stage, limiting treatment options and reducing survival rates–the 5-year survival rate is just 12.5%," said Juan Pablo Hinestrosa, Ph.D., V.P. of Research at Biological Dynamics. "The results of this study show that by analyzing the critical information provided by exosomes and employing machine learning to develop a classifier, our technology platform can detect early-stage pancreatic cancer with high sensitivity and specificity."

Exosomes are tiny circulating particles naturally released from cells into the bloodstream. Historically, isolating these nanoparticles has been challenging due to their low levels, small sizes, and low buoyant density. Biological Dynamics’ ExoVita Pancreas assay, powered by the ExoVerita platform, uses the AC Electrokinetics method for exosome isolation. The proprietary technology is proving to be a precise, automated, and cost-effective method for capturing these particles and analyzing the biomarkers they carry to provide useful information about tumors.

The study, led by Dr. Hinestrosa in collaboration with Rosalie Sears, Ph.D., Oregon Health & Science University (OHSU), used the ExoVerita platform to isolate exosomes from blood samples collected from individuals with pancreatic cancer along with healthy donors and donors at high-risk for pancreatic cancer. A training set of samples was used to develop the ExoVita Pancreas assay, which assesses cancer risk based on a multi-biomarker signature and a machine learning-based classifier scoring. The assay was subsequently validated on an independent cohort of 113 subjects (30 PDAC cases stages I and II, 83 controls), with a performance of 90.0% sensitivity and 92.8% specificity.

"Now that we are beginning to understand the important story that exosomes tell when it comes to human health and disease, novel tools and biomarker approaches are opening new frontiers for early disease detection," said Paul R. Billings, M.D., Ph.D., CEO and Director of Biological Dynamics. "Driven by our Verita technology, the ExoVita test can detect challenging diseases like pancreatic cancer earlier than ever. With further testing in real-world settings, we are confident our exosome enabled test will be useful for high-risk surveillance and early detection of pancreatic cancer, resulting in improved patient outcomes."