ASCO – Oral Cancer News

FDA Grants Fast Track Designation to PDS0101 Plus Pembrolizumab in Advanced Head and Neck Cancer

Author: Ariana Pelosci Source: www.cancernetwork.com Fast track designation was granted to PDS0101 plus pembrolizumab, which is currently being assessed in the phase 2 VERSATILE study in patients with recurrent or metastatic human papillomavirus 16–positive head and neck cancer. PDS0101 plus pembrolizumab (Keytruda) has been granted fast track designation by the FDA for patients with recurrent or metastatic human papillomavirus (HPV) 16–positive head and neck cancer, according to a press release from PDS Biotechnology.1 The combination is currently being investigated in the phase 2 VERSATILE-002 study (NCT04260126) in the aforementioned patient population. PDS0101 is a subcutaneous T cell HPV-specific immunotherapeutic that can encourage high levels of CD8-positive and CD-4 positive T cells. This is achieved by activating numerous immune pathways. These T cells have been observed to target different tumors that have occurred as a result of HPV16 infection. “We are thrilled that the FDA has granted fast track designation for PDS0101 in combination with [pembrolizumab],” Frank Bedu-Addo, PhD, chief executive officer of PDS Biotech, said in the press release. “The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores the potential of the Versamune® platform and the need for a new therapy that may improve outcomes for those with this devastating disease.” At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, results from the trial were presented.2 In stage 1 of the study, 17 patients were included who were checkpoint inhibitor naïve with 4 [...]

OCF News Team - B2022-06-29T15:16:49-07:00June, 2022|Oral Cancer News|

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com Author: Laura Panjwani Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD. “Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.” The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator's choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN. The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator's choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act. Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN. OncLive: What [...]

Charlotte Parker2016-08-24T13:28:58-07:00August, 2016|Oral Cancer News|

Oral temperature changes in head and neck cancer patients predicts side effect severity

Source: American Society for Radiation Oncology The abstract, "Pilot study of functional infrared imaging for early detection of mucositis in locally advanced head and neck cancer reated with chemoradiotherapy," will be presented at the Head and neck Society Meeting in Arizona today. This is a synopsis of that presentation. Slight temperature increases of the oral mucus membranes early in a head and neck cancer patient's chemotherapy and radiation therapy (chemoradiotherapy) treatment is a predictor of severe mucositis later in treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium, sponsored by AHNS, ASCO, ASTRO and SNM. Mucositis, or mouth sores, is a common side effect of chemoradiotherapy for head and neck cancer that is painful and can be very severe. Physicians cannot predict which patients will have mild mucositis or severe mucositis that would require narcotic pain medication, nutritional support and/or feeding tubes. Researchers in this study hypothesized that using sensitive thermal imaging technology to measure temperature changes of less than one-tenth of a degree early in treatment could predict the severity of mucositis later in treatment. This knowledge could allow for early intervention and potential changes in therapy using a technology that is simple, harmless and non-invasive. Patients receiving chemoradiotherapy underwent baseline and weekly thermal imaging of their oral mucus membranes. All patients displayed an increase in temperature and severe mucositis was found in 53 percent of patients. "If we could predict which patients were going to suffer the greatest toxicity, we could proactively make changes to [...]

Charlotte Parker2012-01-26T15:32:36-07:00January, 2012|Oral Cancer News|

Researchers confirm link between HPV and head and neck cancer but survey shows public ignorance on role of oral sex

Source: Medicalnewstoday.com Author: Olwen Glynn Owen Human papillomavirus (HPV) is an important causative agent in squamous cell cancers of head and neck (HNSCC) a new meta-analysis presented at the American Society of Clinical Oncology (ASCO) confirms; but a separate European survey at the same meeting reveals the public is woefully ignorant about it and possible ways to avoid it. Lack of public awareness about the possible link between HPV-related head and neck cancer and oral sex with multiple partners presents a case for making vaccinations against HPV more widely available to boys as well as girls before they become sexually active, commented leading expert Professor Jean-Louis Lefebvre of Centre Oscar Lambret, Lille, France. Researchers led by Farshid Dayyani at the MD Anderson Cancer Center, Houston, Texas, looked at a total of almost 7000 patients who developed head and neck cancer over the past 20 years to gauge the prevalence of HPV - a possible causative agent. They included studies which had tested for the virus in serum or in tumour tissue by PCR and found almost a quarter of patients (24.2%) had HPV positive tumours. Of these the vast majority (86.8%) were positive for HPV 16, the virus also associated with cervical cancer. Overall, the researchers concluded that being HPV positive increased the risk of developing head and neck cancer by 40 per cent. But being HPV16 positive increased the risk more than fourfold (4.47 times higher) compared to HPV16 negative patients. However, people with HPV-associated head and neck cancer lived [...]

Charlotte Parker2009-06-19T07:40:26-07:00June, 2009|Oral Cancer News|