HPV-related carcinoma

Pictured: Merck & Co. headquarters in Silicon Valley iStock/Sundry Photography Merck has unveiled plans to ramp up its human papillomavirus portfolio with a new vaccine, starting a trial launch in the fourth quarter of this year, the company announced Wednesday at the EUROGIN 2024 HPV Congress. The new multi-valent HPV vaccine aims to give broader protection against multiple types of the viral infection. According to Merck, the company has been working to identify new candidates to protect against a more comprehensive array of HPV, with its latest addition to the pipeline using its virus-like particle technology to incorporate more particles and expand coverage. This includes several types that impact Asian and African populations and those of African and Asian descent. Merck is also planning to conduct trials in male and female patients to evaluate the safety and efficacy of a single-dose regimen of Gardasil 9 versus the approved three-dose regimen. “Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” Merck CMO Eliav Barr said in a statement. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.” Merck is planning for two separate clinical trials in males and females between 16 and 26 years of age to examine a single dose’s short- and long-term efficacy and immunogenicity. The trials are expected to enroll patients in the fourth quarter of 2024. The vaccine is currently cleared for females aged nine through 45 years to prevent several types of cancers caused by HPV types, including cervical, vulvar, oropharyngeal, and head and neck cancers. Gardasil and Gardasil 9 are key earners for Merck, as the vaccine pulled in over $8.8 billion in revenue in 2023, a 29% increase from 2022. However, Merck is not stopping with just HPV vaccines. The company is looking to challenge Pfizer in the pneumococcal vaccine arena as the FDA granted priority review for a Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine, with a PDUFA date set for June 17, 2024. Merck is also working with Moderna to create a combination of its cancer drug Keytruda and an mRNA vaccine, which has shown improvement in melanoma at the three-year mark. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Data presented showcases clinical utility of NavDx for patients with HPV-driven anal cancer WALTHAM, Mass.--(BUSINESS WIRE)-- Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16. NavDx is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer. The test provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications, leading to recent positive Medicare and commercial insurance coverage policies. "We are glad to be presenting our latest findings at EUROGIN, including the first study highlighting the utility of NavDx in the surveillance of patients, post-treatment, for recurrent anal cancer,” said Barry M. Berger, MD, Chief Medical Officer at Naveris. "The research we and our partners have the opportunity to share at this conference showcases the clinical significance of the NavDx test in the detection and surveillance of multiple types of HPV-driven cancers, building on the body of evidence supporting its use at every stage of these viral driven cancers.” "Our study marks a significant advancement in the surveillance of anal squamous cell carcinoma, demonstrating that circulating TTMV-HPV DNA significantly enhances early detection of recurrence, giving patients battling HPV-driven cancers a chance for better outcomes,” said Shane Lloyd, MD, Associate Professor of Radiation Oncology at University of Utah School of Medicine and Huntsman Cancer Institute, and the presenting author for the study. “This precision medicine approach, leveraging advanced molecular diagnostics, could enable more prompt and individualized treatments." Following are oral presentations from Naveris and its partners at EUROGIN 2024 showcasing the clinical utility of NavDx for patients with HPV-driven anal cancer: FC 07-9: Detection of patients with recurrent HPV-driven anal cancer using circulating tumor HPV DNA Presenting Author: Shane Lloyd, MD; University of Utah School of Medicine and Huntsman Cancer Institute Session, Date/Time: Anus – Free Communications | March 13, 2024 | 1:45PM – 3:25PM CET Results were presented from the first multi-institutional analysis of the NavDx test ordered during routine clinical practice for the post-treatment surveillance of patients with HPV-driven anal squamous cell carcinoma (ASCC). The test showed high positive and negative predictive values of 100% and 98.6%, respectively, when ordered through routine clinical use in this cohort of 33 patients, comparable to its use in HPV-driven oropharyngeal cancer. Positive NavDx test results successfully pinpointed patients with recurrences in all cases, highlighting the test's utility as a potent surveillance tool in daily clinical practice for early detection of recurrence. FC 07-12: Circulating tumor tissue modified viral-human papillomavirus DNA (TTMV-HPV DNA) is a biomarker of response to pembrolizumab in anal cancer Presenting Author: Brandon Huffman, MD; Dana-Farber Cancer Institute at Harvard Medical School Session, Date/Time: Anus – Free Communications| March 13, 2024 | 1:45PM – 3:25PM CET Results were presented from a phase II clinical trial involving 32 patients with advanced anal cancer treated with pembrolizumab. This study explored NavDx as a potential biomarker for monitoring disease response. Initial findings indicate baseline sensitivity and specificity of 95% and 100%, respectively. The study additionally found that pre-treatment NavDx levels were indicative of tumor burden in the recurrent and metastatic setting and that changes in these levels were significantly associated with clinical outcomes. Together this highlights the utility of NavDx as a dynamic tool for early assessment of therapeutic response. Additional updates will be presented as part of the EUROGIN 2024 HPV and Head & Neck Cancer Forum: HN05-2: DART 2.0 (Mayo) Presenting Author: Daniel Ma, MD; Mayo Clinic Session, Date/Time: HN – HPV and Head & Neck Forum, Management | March 15, 2024 | 10:00AM – 11:30AM CET Details of the trial design from the ongoing DART 2.0 trial will be shared (NCT05541016). The DART 2.0 trial evaluates the ability of NavDx to improve treatment intensity selection in patients with HPV-driven head and neck cancer to best balance the side effects of treatment with decreasing cancer recurrence. DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where post-treatment detectability of NavDx was a significant risk factor for cancer recurrence in patients with head and neck cancer. HN 07-3: TTMV-HPV DNA for surveillance in the clinic Presenting Author: Eleni Rettig, MD, FACS; Brigham and Women's Hospital and Dana-Farber Cancer Institute at Harvard Medical School Session, Date/Time: HN – HPV and Head & Neck Forum, Molecular Diagnosis and Surveillance | March 15, 2024 | 2:30PM – 4:00PM CET Early insights will be shared from the first prospective cohort study examining biomarker-led monitoring for early detection of recurrent HPV-positive oropharyngeal cancer (OPC) (NCT04965792). The study involved 150 patients, with NavDx tested pre-treatment and every three months post-treatment and patients followed for five years. 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 and . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA). View source version on businesswire.com: Contacts Megan Kernan ICR Westwicke Healthcare PR Tel: 646.677.1870 Megan.Kernan@icrinc.com Source: Naveris, Inc. View this news release online at:

March 13, 2024 3:00 am ET Company reaffirms commitment to reduce the global burden of HPV-related diseases, including certain cancers RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today, at the EUROGIN 2024 HPV Congress, announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types. Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL ® 9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen. “Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.” In the U.S., GARDASIL 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Multivalent HPV vaccine research Merck vaccine researchers continue to build on the development of GARDASIL and GARDASIL 9 to identify new candidates with the potential to extend protection against a broader array of HPV types. The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage. This includes several types known to have more impact in African and Asian populations and individuals of African and Asian descent. First-in-human studies (Phase 1) are scheduled to start in the fourth quarter of 2024. Assessing the potential efficacy and durability of a single dose regimen of GARDASIL 9 In response to calls from scientific leaders for more clinical data concerning alternative dosing regimens for GARDASIL 9, Merck, pending regulatory input, plans to conduct two prospective clinical trials, one in females (16-26 years old) and one in males (ages 16-26 years old). These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen. The goal of these large, randomized trials is to generate data that clearly determines whether or not a single dose of GARDASIL 9 provides comparable long-term protection to the approved three-dose regimen, while also satisfying the high standards required by regulatory authorities. The clinical trials are anticipated to start enrolling participants in the fourth quarter of 2024. HPV vaccine supply To address the increasing global demand for GARDASIL and GARDASIL 9 and support broader and equitable access, Merck has made significant investments in manufacturing to help increase supply. Starting in 2019, the company committed to expand manufacturing capacity by increasing production at existing plants as well as constructing new facilities. Between 2017 and 2020 this resulted in a near doubling of supply which has subsequently been doubled again between 2020 and 2024. Merck expects to supply sufficient quantities of HPV vaccines to meet anticipated demand for 2025 and will continue to expand our supply capacity in the future. Indication for GARDASIL and GARDASIL 9 GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age. GARDASIL is a vaccine indicated in females 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age. GARDASIL is indicated in males 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. The GARDASIL 9 oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Indication - Limitations of Use GARDASIL 9 and GARDASIL do not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 and GARDASIL have not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine HPV types to which a person has previously been exposed through sexual activity Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 and GARDASIL protect only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types contained in the vaccines. GARDASIL 9 and GARDASIL are not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 or GARDASIL may not result in protection in all vaccine recipients. Select Safety Information GARDASIL 9 and GARDASIL are contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 and GARDASIL have not been established in pregnant women. For GARDASIL 9, the most common (≥10%) local and systemic adverse reactions in females were: injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. For GARDASIL, the most common (≥1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. The duration of immunity for a 2-dose regimen of GARDASIL 9 is unknown. Dosage and Administration Administer either GARDASIL 9 or GARDASIL intramuscularly in the deltoid or anterolateral area of the thigh. For GARDASIL 9, a complete vaccination regimen consists of: For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months. For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months. For GARDASIL, complete vaccination regimen for individuals aged 9 through 26 years of age consists of 3 doses at the following schedule: 0, 2 months, 6 months. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf Media Contacts: Bob Josephson (203) 914-2372 Muchena Zigomo (+41) 79 7650365 Investor Contacts: Peter Dannenbaum (732) 594-1579 Damini Chokshi (732) 594-1577 Source: Merck & Co., Inc.