Trial underway for novel agent plus immunotherapy for HPV-related head and neck cancer

Source: www.curetoday.com Author: Brielle Benyon Results from a phase 2 clinical trial demonstrated promise for the combination of the novel agent PDS0101 plus Keytruda (pembrolizumab) in treating human papillomavirus (HPV)-associated head and neck cancer. As such, the trial will now progress to full enrollment of 54 patients who have not been previously treated with a checkpoint inhibitor. The trial, VERSATILE-002, involves two groups of HPV16-positive patients with head and neck cancer that is either metastatic or has returned after treatment. One group consists of patients who have no prior treatment with checkpoint inhibition immunotherapy, while the other group is made up of 21 patients whose disease failed checkpoint inhibition — assessment for this group is still ongoing. In the checkpoint inhibitor-naïve group, four or more of the 17 patients achieved an objective response, which was classified by a 30% or more reduction in tumor size. “The achievement of this important milestone in the VERSATILE-002 phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, the developer of PFS101, in a statement. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with Keytruda has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers.” PDS0101 works by inducing large quantities of CD4+ helper and CD8+ killer T cells, a [...]

2022-02-03T10:51:38-07:00February, 2022|Oral Cancer News|

New MSK radiation approach means fewer side effects for more patients with HPV-related head and neck cancer

Source: www.mskcc.org Author: Memorial Sloan Kettering Cancer Center Robert Rosenfeld thought the lump he felt in his neck in late 2018 was just a symptom of a cold that wouldn’t go away. He visited an ear, nose, and throat specialist who saw nothing upon first examination, but Robert knew something was wrong and asked for a CT scan. The specialist called him with the bad news: It was almost certainly cancer. A biopsy confirmed he had stage 2 cancer at the base of his tongue and 2 nearby lymph nodes. The tumor was positive for the human papillomavirus (HPV). Robert, then a 69-year-old car salesman on Long Island, met with cancer doctors near his hometown of Hauppauge, New York, to learn about treatment options. He realized he faced a tough road: Standard treatment would be 7 weeks of radiation, during which he also would receive 3 rounds of chemotherapy. The standard radiation dose would likely cause mouth sores, difficulty swallowing, dry mouth (from damage to salivary glands), loss of taste, and nausea. Robert wanted a second opinion, and his medical oncologist strongly recommended Memorial Sloan Kettering Cancer Center. When Robert called, he was able to get in to see radiation oncologist C. Jillian Tsai the very next day. “When I met Dr. Tsai, she was amazing,” Robert says. “She told me what I was up against but also that the cancer I had was curable.” There was another major plus: Dr. Tsai was able to offer a significantly reduced radiation [...]

Molecular profiling identifies potential prognostic biomarker for treatment response in HNSCC

Source: www.ajmc.com Author: Matthew Gavidia Human papillomavirus surrogate marker p16 was identified as a potential prognostic biomarker for standard-of-care immune checkpoint blockade therapy response in non-oropharyngeal head and neck squamous cell carcinoma. Real-world overall survival among patients with oropharyngeal squamous cell carcinoma (OPSCC) and non-OP head and neck squamous cell carcinoma (HNSCC) differed significantly based on the presence of the human papillomavirus (HPV) surrogate marker p16, with further implications identified regarding time on treatment with immune checkpoint blockade (ICB) therapies. Findings were published in Cancers. Identified as the sixth most common cancer worldwide with incidence expected to increase by 32% in the next 2 decades, patients with recurrent and/or metastatic HNSCC typically have a poor prognosis. Although diagnosis of HNSCC is typically related to tobacco and alcohol use, incidence of HPV-associated HNSCC has risen substantially, in which those positive for the virus whose HNSCC stems in the oropharynx have exhibited better survival outcomes. Researchers sought to further investigate the association of HPV and/or its surrogate marker p16 with response to standard-of-care ICB therapies in patients with OPSCC and non-oropharyngeal (non-OP) HNSCC. “We also investigated other potential biomarkers and mutations that may predict improved response to ICB in both HPV-positive and -negative patients with HNSCC,” they added. Patients registered in the Caris Life Sciences CODEai database with non-OP HNSCC and OPSCC were recruited and identified by comprehensive molecular profiling to be positive or negative for p16. In total, 2905 HNSCC (OPSCC, n = 948) cases were identified. Of those tested for [...]

Achieving an 80% HPV vaccination rate could eliminate nearly 1 million cases of male oropharyngeal cancer this century

Source: medicalxpress.com Author: University of Texas Health Science Center at Houston A nationwide effort to adequately vaccinate 8 in 10 adolescents against the human papillomavirus (HPV) could prevent 934,000 cases of virus-associated, male oropharyngeal cancer over this century, reported investigators at The University of Texas Health Science Center at Houston (UTHealth Houston) School of Public Health in The Lancet Regional Health—Americas. At the start of each decade, the Healthy People program of the U.S. Department of Health and Human Services establishes goals to reduce the most significant preventable threats to health, which include an 80% target for the HPV vaccination program. However, in the U.S., just 54% of adolescents and only 21% of young adults were adequately vaccinated as of 2019. To gage the effect of accomplishing an 80% target on male oropharyngeal cancer, the most common cancer caused by HPV, UTHealth Houston researchers created a simulation model to project the development of this cancer over a lifetime and to measure the impact of the HPV vaccination. "Our study is the first to develop and validate a comprehensive mathematical modeling framework of the natural history of oral HPV infection and its progression to oropharyngeal cancer," said Ashish A. Deshmukh, Ph.D., MPH, the study's senior author and an associate professor in the Department of Management, Policy and Community Health and associate director of the Center for Health Services Research at UTHealth School of Public Health. "Achievement of the 80% goal by 2025 and maintaining it could lead to the prevention of [...]

2021-12-16T08:47:19-07:00December, 2021|Oral Cancer News|

Liquid biopsy provides accurate, fast Dx of HPV-associated head and neck cancer

Source: www.medpagetoday.com Author: Mike Bassett, Staff Writer, MedPage Today The use of liquid biopsy for the diagnosis of human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) was more accurate, faster, and less expensive than standard tissue-based biopsies, according to a prospective observational study. The sensitivity and specificity of this circulating tumor HPV DNA-based approach were 98.4% and 98.6%, respectively, with positive and negative predictive values of 98.4% and 98.6%, reported Daniel L. Faden, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues. The diagnostic accuracy of this non-invasive approach was significantly higher than standard of care (Youden index 0.968 vs 0.707, P<0.0001), they noted in Clinical Cancer Research. In addition, liquid biopsy reduced the time to diagnosis from a median of 41 days to 15 days, and estimated costs associated with this method were about 36% to 38% less than the traditional biopsy approach. "Currently the way we diagnose HPV-associated cancer is either with a needle biopsy of a neck lymph node or a tissue biopsy from the oropharynx -- and these approaches have a couple of different limitations," Faden told MedPage Today. Not only are they invasive and painful for patients, but needle biopsy of a neck lymph node has high failure rates due to a lack of adequate cellular material. "So, patients might have to undergo a repeat biopsy to get the diagnosis we are waiting for," he noted. "That adds time to diagnosis, and we know that time from presentation to [...]

2021-12-03T05:54:26-07:00December, 2021|Oral Cancer News|

Treatment paradigms are shifting for locally advanced HPV-positive head and neck cancers

Source: www.onclive.com Authors: Kaveh Zakeri, MD, MAS, Nancy Y. Lee, MD The standard of care for patients with locally advanced head and neck squamous cell carcinomas does not substantially differ according to human papillomavirus (HPV) status in the National Comprehensive Cancer Network guidelines.1 Resectable tumors can be treated with surgery followed by adjuvant therapy. Alternatively, definitive chemoradiation therapy with cisplatin is the other dominant treatment paradigm. Incidence of HPV-associated oropharyngeal squamous cell carcinoma has increased rapidly and is associated with higher overall survival (OS) compared with cancers caused by smoking and alcohol.2,3 Given the unique biology of HPV-associated oropharyngeal disease, a separate staging system was developed for these tumors.4 HPV-associated oropharyngeal cancers are more radiosensitive and chemosensitive than cancers caused by smoking and alcohol, yet the traditional treatment paradigms—including high doses of radiation and chemotherapy—were developed prior to the epidemic of HPV-associated disease. De-escalation of therapy has been proposed for HPV-associated oropharyngeal cancer based on data demonstrating high OS and progression-free survival (PFS).5 De-escalation of therapy has been investigated for both definitive surgical and chemoradiation therapy paradigms. Most de-escalated approaches focus on selecting patients according to clinical features, such as disease stage and smoking status, whereas personalized de-escalation reduces treatment intensity for patients according to treatment response. Transoral Robotic Surgery Followed by Adjuvant Radiotherapy Transoral robotic surgery (TORS) is a minimally invasive approach that reduces morbidity compared with traditional, open surgery for patients with oropharyngeal cancers. TORS is a standard of care option for patients with resectable tonsil or base [...]

2021-11-23T08:16:08-07:00November, 2021|Oral Cancer News|

Most men benefit from initial and catch-up cancer prevention vaccination

Source: www.precisionvaccinations.com Author: Don Ward Hackett The Lancet Infectious Disease published the results from an extensive cancer prevention phase 3 study on November 12, 2021, supporting quadrivalent HPV vaccination in men, including catch-up vaccinations. The Gardasil quadrivalent human papillomavirus (HPV) vaccine was shown to prevent infections and lesions related to HPV6, 11, 16, and 18 in men aged 16–26 years. The researchers assessed the incidences of external genital warts related to HPV6 or 11 and external genital lesions and anal dysplasia associated with HPV6, 11, 16, or 18, over ten years of follow-up. The 3-year Base Study was an international, double-blind, randomized, placebo-controlled trial done at 71 sites in 18 countries. The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2, and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36. And the 7-year, open-label, long-term follow-up extension study was done at 46 centers in 16 countries. Between August 2010 and April 2017, 1,803 participants were enrolled in the long-term follow-up study, of whom 936 (827 heterosexual men and 109 MSM) were included in the early vaccination group and 867 (739 heterosexual men and 128 MSM) were included in the catch-up vaccination group. In early vaccine group participants during long-term follow-up compared with the placebo group in the Base Study, the incidence per 10 000 person-years of external genital warts related to HPV6 or 11 was 0·0 (95% CI 0·0–8·7) versus 137·3 [...]

2021-11-16T08:57:09-07:00November, 2021|Oral Cancer News|

HB-200 vaccines show promised in HPV16+ cancers

Source: www.targetedonc.com Author: Sara Karlovitch In an interview with Targeted Oncology, Marshall Posner, MD, discusses the use of the HB-201 and HB-202 vaccines in patients with human papillomavirus 16- positive cancers. Adding pembrolizumab (Keytruda) to the HB-200 vaccines may help to improve efficacy in patients with human papillomavirus 16- positive (HPV16+) cancers, according to data from a phase 1 study. HPV16+ cancers are caused by the expression of E7 and E6 oncoproteins, which is a source of immunogenic neoantigens. A tumor-specific T-cell response is induced by replicating arenavirus vectors HB-201 and HB-202. The study (NCT04180215) assessed HB-201 monotherapy and HB-201 and HB-202 alternating 2-vector therapy intravenously with or without 1 intratumoral dose in HPV16+ cancers. An interim analysis looked at 38 patients with confirmed HPV16+ cancers. In total, 18 patients received HB-201 monotherapy, 9 received the monotherapy intravenously with or without 1 intratumoral dose and 11 patients received HB-201/HB-202 alternating therapy. In an interview with Targeted Oncology™, Marshall Posner, MD, a professor of medicine, hematology and medical oncology at Mount Sinai, discusses the use of the HB-201 and HB-202 vaccines in patients with HPV16+ cancers. TARGETED ONCOLOGY: Can you go over the safety, efficacy, and immunogenicity of arenavirus-based vectors HB-201 and HB-202 in patients with HPV16+ cancers? POSNER: This is a first in human phase 1 trial with expansion cohorts, to occur later, of 2 vaccines. One is a lympho-choriomeningitis virus-based arenavirus vaccine and the other is a pichinde virus-based vaccine, both of which express the E6 and E7 proteins, [...]

FDA gives ISA101b fast track designation for HPV 16+ oropharyngeal cancer

Source: www.cancernetwork.com Author: Hayley Virgil The first patients with human papillomavirus 16–positive oropharyngeal cancer have been dosed with ISA101b, which was given a fast track designation by the FDA, as part of a phase 2 study. ISA101b has received a fast track designation from the FDA for the treatment of patients with recurrent and metastatic human papillomavirus (HPV) 16–positive oropharyngeal cancer, according to a press release from drug developer ISA Pharmaceuticals.1 The fast track designation is intended to facilitate the development of investigational therapies that may help to address unmet medical needs for serious or life threatening diseases. An ongoing randomized, double-blind phase 2 trial is examining cemiplimab (Libtayo) with or without ISA101b and has an estimated enrollment of 194 patients (NCT03669718). “Recurrent and metastatic HPV16-positive OPC is a form of head and neck cancer with a high unmet medical need. The Fast Track designation for ISA101b underlines the potential benefit of this immunotherapy for patients suffering from this disease,” Leon Hooftman, chief medical officer at ISA Pharmaceuticals, said in a press release. ISA101b elicits strong and specific immune responses to HPV16 virus proteins and creates a robust T-cell immune response against cancerous cells or tissues. In the ongoing trial, patients in the experimental arm will receive ISA101b 3 times over 3 weeks plus cemiplimab every 3 weeks for up to 24 months, and the control arm will receive a matched placebo plus cemiplimab at the same dose. The primary outcome measures are overall response rate and safety, with a [...]

2021-09-15T06:04:52-07:00September, 2021|Oral Cancer News|

Study: HPV vaccination will reduce throat and mouth cancers, but overall impact will take 25-plus years to see

Source: www.newswise.com Author: Johns Hopkins Bloomberg School of Public Health Vaccinations against human papillomavirus (HPV), a major cause of throat and back of mouth cancers, are expected to yield significant reductions in the rates of these cancers in the U.S., but will not do so until after 2045, according to a new modeling study from researchers at the Johns Hopkins Bloomberg School of Public Health. HPV is the most common sexually transmitted infectious virus worldwide. HPV infections are often silent, and while most infections clear, some are chronic and can trigger cancers including mouth and throat (oropharyngeal), and cervical cancer because they disrupt DNA and inhibit tumor-suppressor proteins in the cells they infect. Although there is no cure for existing HPV infections, new infections are preventable with vaccines, the first of which entered use in the U.S. in 2006. In the new study, the Bloomberg School researchers analyzed national databases on oropharyngeal cancer cases and HPV vaccinations, and projected the impact of HPV vaccination on the rates of these cancers in different age groups. They estimated that the oropharyngeal cancer rate would nearly halve between 2018 and 2045 among people ages 36–45. However, they also projected that the rate in the overall population would stay about the same from 2018-2045, due to still-rising rates of these cancers in older people, where most of these cancers occur. The study appears online September 2 in JAMA Oncology. “We estimate that most of the oropharyngeal cancers from 2018 to 2045 will occur among [...]

2021-09-03T12:26:37-07:00September, 2021|Oral Cancer News|
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