HPV positive oropharyngeal squamous cell carcinoma

WALTHAM, Mass.--( BUSINESS WIRE )-- Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today announced the presentation of new data at the 2024 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) , taking place September 28 – October 1, 2024 in Miami Beach, Florida. These presentations highlight the continued innovation of the NavDx ® test , the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV ® )-HPV DNA blood test, which aids in the detection and management of HPV-driven oropharyngeal cancers. “The AAO-HNS meeting provides a critical platform to share our latest advancements in the detection and management of HPV-associated oropharyngeal cancer,” said Barry M. Berger, M.D., Chief Medical Officer at Naveris. “The NavDx test continues to prove its value as a leading tool in detecting molecular residual disease, allowing clinicians to monitor patients post-treatment with precision and make informed decisions that can directly impact patient care.” Oral Presentations: The following three oral presentations will be part of the Scientific Oral Presentations 1 - Head and Neck Surgery session, which will be held on Saturday, September 28, 2024, from 9:30 AM – 10:30 AM EDT at the Miami Beach Convention Center (MBCC), Room 208. Saturday, September 28, 2024 | 9:42 AM – 9:48 AM EDT Circulating Tumor Tissue-Modified-Viral-HPV DNA and Correlation With Disease Burden in Oropharyngeal Cancer Presenting Author: Jaclyn Lee, M.D. | Senior Author: Michael C. Topf, M.D., MSCI Vanderbilt University Medical Center, Nashville, TN This study evaluates the association between pre-treatment TTMV-HPV DNA and clinical tumor staging, nodal staging, and imaging results in patients with HPV+ oropharyngeal squamous cell carcinoma (OPSCC), reporting an independent association between pretreatment TTMV-HPV DNA and clinical nodal staging. Saturday, September 28, 2024 | 9:54 AM – 10:00 AM EDT Association of Circulating Tumor HPV DNA Score and Clinicopathologic Characteristics in HPV-Associated Oropharyngeal Cancer Presenting Author: Shimrit Sharav, M.D. | Senior Author: Terry Day, M.D. Sarah Cannon Cancer Institute, Charleston, SC This study explores the relationship between TTMV-HPV DNA and clinicopathological factors, showing significant correlations between the TTMV-HPV DNA and nodal disease burden in HPV+ OPSCC patients. Saturday, September 28, 2024 | 10:12 AM – 10:18 AM EDT Liquid Biopsy in Diagnosis and Surveillance of HPV-Associated Oropharyngeal Cancer: A Systematic Review Presenting Author: Susmita Chennareddy, B.A. | Senior Author: Scott A. Roof, M.D. Icahn School of Medicine at Mount Sinai, New York, NY This systematic review assesses the diagnostic accuracy and clinical utility of circulating tumor DNA (ctDNA) technologies in HPV-associated OPSCC, including the NavDx assay, concluding that ctDNA demonstrates high sensitivity and specificity for disease detection, treatment monitoring, and recurrence surveillance. The following presentation will be part of Scientific Oral Presentations 3 - Head and Neck Surgery on Sunday, September 29, 2024, from 9:30 AM – 10:30 AM EDT at MBCC, Room 208. Sunday, September 29, 2024 | 9:54 AM – 10:00 AM EDT Examining Patients’ Opinions on NavDx During Head and Neck Cancer Surveillance: An Exploratory Study Presenting Author: Amanda Joy Bastien, M.D. | Senior Author: Allen S. Ho, M.D. Cedars Sinai, Los Angeles, CA This study evaluates patient opinions on NavDx as a molecular surveillance tool, highlighting themes such as convenience, cost, and perceived test validity. The following panel presentations will also incorporate a discussion of the NavDx test: Monday, September 30, 2024 | 8:00 AM – 9:00 AM EDT | MBCC, Room 207 HPV: Is It in Your DNA Moderator: Marianne Abouyared, M.D. | Panelists: Eleni Rettig, M.D., Rusha J. Patel, M.D., Antoine Eskander, M.D., Sc.M. University of California Davis Medical Center, Brigham and Women’s Hospital, The University of Oklahoma Health Sciences Center, Sunnybrook Health Sciences Centre This panel will discuss the role of HPV in oropharyngeal cancers, including the use of circulating HPV DNA (HPV ctDNA) as a surveillance tool, presenting evidence for its integration into clinical practice and how to navigate patient-provider conversations around HPV-related malignancies. Poster Presentations: Monday, September 30, 2024 | 12:00 PM – 1:00 PM EDT | Exhibit Hall A-D (0610) Association Between Routine Laboratory Inflammatory Indicators and Circulating Tumor DNA Levels in HPV-Positive Oropharyngeal Carcinoma Presenting Author: Ryan S. Ziltzer, M.D., MPH | Senior Author: Meghan T. Turner, M.D. West Virginia University, Morgantown, WV This pilot study suggests that certain inflammatory indices are significantly associated with higher TTMV-HPV DNA Scores in OPSCC, indicating their potential utility as surrogate markers for disease monitoring. Naveris will be exhibiting at the conference at Booth #718, where attendees can learn more about NavDx and its impact on optimizing surveillance of oropharyngeal cancer recurrence and informing the care of patients with HPV-driven cancers. For more information about Naveris and NavDx, please visit www.naveris.com and www.NavDx.com . About Naveris Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).

Adela's tissue-agnostic MRD test has been clinically validated to predict and surveil for recurrence in patients with head & neck cancer, regardless of HPV status The test identified recurrences in head & neck cancer up to 14.9 months before standard of care clinical exam and imaging FOSTER CITY, Calif., Sept. 14, 2024 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, has successfully completed clinical validation of its MRD test to predict and surveil for recurrence in head & neck cancer. Results have been published in Annals of Oncology1 and are being presented during an Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2024. "Blood-based MRD testing has the potential to transform recurrence monitoring for patients with head & neck cancer. Currently, the majority of recurrences are not detected until symptoms or physical findings are reported by the patient2. By identifying signals of disease prior to clinical presentation or routine imaging with MRD testing, recurrences can be treated earlier and more effectively," said Geoffrey Liu, MSc, MD, Medical Oncologist and Senior Scientist, Princess Margaret Cancer Centre, University Health Network (UHN). "The clinical validation results from Adela's MRD test demonstrate that the test identified recurrences up to 14.9 months earlier than standard of care clinical exam and imaging." The ability of Adela's test to quantify cfDNA cancer signal and predict and surveil for recurrence was evaluated in individuals diagnosed with stage I-IVB human papillomavirus (HPV)-positive oropharyngeal and HPV-negative head and neck cancer treated at Princess Margaret Cancer Centre, University Health Network. This comprehensive patient cohort, based on rigorous data collection, provided a strong foundation for evaluating the test's performance. The full study cohort included >1,100 plasma samples collected from >300 patients. 484 plasma samples from 149 patients were included in the validation analysis. In the study, blood draws occurred before and after curative intent treatment, and in a subset of patients, at mean 12 and 24 months post-curative intent treatment. In the validation analysis, Adela's MRD test demonstrated the ability to identify recurrences up to 14.9 months before standard of care clinical exam and imaging, with a mean lead time of 4.1 months. Sensitivity for recurrence in the surveillance setting was 91% at 88% specificity. Significant differences in recurrence-free survival (RFS) were observed when patients were stratified by MRD positivity (HR of 35.7 (P<0.001)). MRD status showed significant association with RFS in both HPV-positive and HPV-negative disease. "We are highly encouraged by the validation results of Adela's MRD test, demonstrating strong test performance without the added complexity of obtaining a patient's tumor tissue sample or building an individualized panel," said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. "For patients with head and neck cancer, in particular, tumor tissue samples are often not available. A blood-only, tissue-agnostic offering such as Adela's is the only way to make MRD testing universally accessible to those who will benefit." "These strong validation results exemplify the ability of Adela's genome-wide methylome enrichment platform to maximize detection of cancer signal in the blood by efficiently capturing and preserving the information-rich methylated regions of the genome. This single liquid biopsy platform can be applied across cancer types, and we look forward to replicating these promising results in additional cancer types in the near future," said Dr. Daniel De Carvalho, Chief Scientific Officer of Adela and Senior Scientist at Princess Margaret Cancer Centre, University Health Network. A Research Use Only (RUO) version of Adela's MRD test is currently available to biopharmaceutical companies and other investigators for use in biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making. Presentation Details Presentation Number 64O - Clinical validation of a tissue-agnostic genome-wide methylome enrichment MRD assay for head and neck cancers Shao Hui Huang, MD, MSc, MRT(T) 3 Saturday September 14, 2024 15:35 PM CEST Salamanca Auditorium, Hall 5 About Adela Adela is developing best-in-class technology to accelerate the diagnosis and improve the management of cancer through blood tests for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Adela's genome-wide methylome enrichment platform, which utilizes the company's patented cfMeDIP-seq platform, efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. The company's platform specifically isolates the information-rich (methylated) regions of the genome through a high-affinity enrichment process, enabling it to capture and preserve more genomic material for sequencing compared to other platforms that use enzymatic or chemical treatment (bisulfite conversion). This comprehensive view of the methylome significantly increases the opportunities for Adela's products to detect cancer signals in the blood compared to approaches that target a smaller set of genomic regions. It also enables enhanced prognostic and predictive abilities, as well as dynamic monitoring in patients over time. Adela's approach to MRD testing is tissue agnostic, eliminating the burden of acquiring a tumor sample. Adela's investors are F-Prime Capital, OrbiMed, Deerfield Management, Decheng Capital, RA Capital Management, and Labcorp. Find more information at adelabio.com. About UHN UHN is Canada's No. 1 hospital and the world's No. 1 publicly funded hospital. With 10 sites and more than 20,000 members of TeamUHN, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education at UHN and West Park Healthcare Centre. As Canada's top research hospital, the scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. 1 Liu G et al., Clinical validation of a tissue-agnostic genome-wide methylome enrichment MRD assay for head and neck malignancies. Annals of Oncology. 2024. 2 Agrawal A et al., Role of the physician versus the patient in the detection of recurrent disease following treatment for head and neck cancer. Laryngoscope. 2004 Feb;114(2):232-5. doi: 10.1097/00005537-200402000-00011. 3 Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada SOURCE Adela WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FRIDAY, June 28, 2024 -- In a clinical practice guideline issued by the American Society for Radiation Oncology and published online June 18 in Practical Radiation Oncology , recommendations are presented for the use of radiation therapy (RT) for management of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). Danielle N. Margalit, M.D., M.P.H., from Brigham and Women's/Dana-Farber Cancer Center in Boston, and colleagues addressed five key questions on the use of RT for management of HPV-associated OPSCC. Recommendations were based on a systematic review of the literature and predefined consensus-building methodology. The researchers recommended concurrent cisplatin for patients receiving definitive RT with T3 to 4 disease and/or one node >3 cm, or multiple nodes. Concurrent cetuximab, carboplatin/5-fluorouracil, or taxane-based systemic therapy are conditionally recommended for similar patients ineligible for cisplatin. RT with concurrent cisplatin is recommended for positive surgical margins or extranodal extension in the postoperative setting. For pT1 to 2 disease and a single node ≤3 cm, without other risk factors, observation is conditionally recommended. For patients treated with definitive RT with concurrent systemic therapy, 7,000 cGy in 33 to 35 fractions is recommended; 5,600 to 6,000 cGy is recommended for patients receiving postoperative RT without positive surgical margins and extranodal extension. Intensity modulated RT is recommended over three-dimensional techniques for all patients receiving RT, with reduction in dose to critical organs-at-risk. About three months after definitive RT/chemoradiation, reassessment with positron emission tomography-computed tomography is recommended. "This updated guideline underscores the importance of tailored radiation strategies that maximize patient survival while minimizing side effects," Margalit said in a statement. Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.