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 [...]

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

HPV is changing the face of head and neck cancers

Source: www.healio.comAuthor: Christine Cona A drastic increase in the number of HPV-associated oropharynx cancers, particularly those of the tonsil and base of tongue, has captured the attention of head and neck oncologists worldwide. In February, at the Multidisciplinary Head and Neck Cancer Symposium in Chandler, Ariz., Maura Gillison, MD, PhD, professor and Jeg Coughlin Chair of Cancer Research at The Ohio State University in Columbus, presented data that showed that the proportion of all head and neck squamous cell cancers that were of the oropharynx — which are most commonly HPV-positive cancers — increased from 18% in 1973 to 32% in 2005. Maura Gillison, MD, PhD, Jeg Coughlin Chair of Cancer Research at The Ohio State University, said screening for HPV in the head and neck is years behind cervical screening for HPV.   In addition, studies from the United States, Europe, Denmark and Australia indicate that HPV-positive patients have a more than twofold increased cancer survival than HPV-negative patients, according to Gillison. With the rising incidence of HPV-related oropharynx cancers, it will soon be the predominant type of cancer in the oral or head and neck region, according to Andy Trotti, MD, director of radiation oncology clinical research, H. Lee Moffitt Cancer Center & Research Institute, in Tampa, Fla. “We should be focusing on HPV-related oropharyngeal cancer because it will dominate the field of head and neck cancers for many years,” he said during an interview with HemOnc Today. “It is certainly an important population for which to continue to [...]

2016-06-03T11:11:05-07:00June, 2016|Oral Cancer News|

Research Leader Discusses FDA-Funded Immunotherapy for Head and Neck Cancer

 Source: www.onclive.comAuthor: Gina Columbus  Brett Miles, MD, DDS   The investigational immunotherapy axalimogene filolisbac (ADXS11-001) has emerged as a potentially practice-changing agent in the treatment of HPV-related oropharyngeal cancer. Shown to generate T cells directed against a cancer antigen and neutralize suppressor regulatory T cells and myeloid-derived suppressor cells that protect the tumor microenvironment from an immunologic attack and contribute to tumor growth, ADXS11-001 is the first of its kind—a therapeutic vaccine for the disease. The agent is being examined in an ongoing phase II trial, which was reported as one of 18 recipients of research grants recently awarded by the FDA’s Office of Orphan Product Development. The grants, given to sites for product development in rare diseases, total more than $19 million. The ADXS11-001 grant provides collaborating researchers from Baylor College of Medicine and the Icahn School of Medicine at Mount Sinai with more than $1.1 million over 3 years. Eligible patients for the phase II study are newly diagnosed with stage II to IV HPV16-positive oropharynx squamous cell carcinoma who are scheduled to receive ablative transoral robotic surgery. In an interview with OncLive, the study’s surgical principal investigator, Brett Miles, MD, DDS, associate professor of Otolaryngology Head and Neck Surgery, co-chief, Division of Head and Neck Oncology, Icahn School of Medicine at Mount Sinai, discusses the potential of ADXS11-001 in HPV-associated head and neck cancer and other emerging therapies and treatment strategies. OncLive: Congratulations on your study being awarded a research grant from the FDA. How does it [...]

2015-09-29T11:26:02-07:00September, 2015|Oral Cancer News|

FDA Grant Forwards Listeria-Based Throat Cancer Vaccine

Source: www.targetedonc.comAuthor: Sandra Kear An experimental immunotherapy for human papillomavirus-, or HPV-, related throat cancers, which is driven by the Listeria bacteria (that wreaks havoc when ingested), may now move forward due to a $1.1 million dollar grant from the FDA to researchers at Baylor College of Medicine.   “Immunotherapy, such as axalimogene filolisbac, which targets HPV proteins expressed in cancer cells is a great example of using a cancer’s own unique biology against it.” said principal investigator Andrew Sikora, MD, PhD, leader of the head and neck cancer program in the NCI Comprehensive Designated Dan L. Duncan Cancer Center and an associate professor of otolaryngology at Baylor College, in an interview with Targeted Oncology.   "This is hopefully the first step toward development of more targeted treatment approaches that reduce side effects and cancer treatment-related morbidity by uniquely targeting only virus-infected cells.” 
The Listeria-based HPV immunotherapy, axalimogene filolisbac (ADXS11-001), is developed by Advaxis, and functions by stimulating an immune response against HPV proteins, thus killing infected cells.   The drug is currently being evaluated in phase I-II study3 alone or in combination with MedImmune’s durvalumab, in patients with cervical or HPV-positive head and neck cancer. The study has three arms: axalimogene filolisbac alone, durvalumab alone, and the two drugs combined. Primary outcomes established for the study are: number of subjects with adverse events (AEs) in each dose level, number of subjects with AEs in the combination dose, and progression-free survival.   Patients must have measurable disease by RECIST criteria, as well [...]

2015-09-17T09:22:55-07:00September, 2015|Oral Cancer News|

HPV Persistence Predicts Poor Prognosis in Head/Neck Cancer

Source: www.medscape.comAuthor: Roxanne Nelson, RN, BSN Among patients with human papillomavirus–positive oropharyngeal cancer (HPV-OPC), persistence of HPV following treatment is associated with a poorer prognosis. Results of a new study show that the persistence of HPV16 DNA, detected in oral rinses after treatment has ended, may be predictive of disease recurrence. In a cohort of 124 patients with HPV-OPC, HPV16 DNA was detected in oral rinses from 54% (n = 67) of patients at the time of their diagnosis. Following treatment, it was detected in only six patients after treatment, including five patients with persistent oral HPV16 DNA that was also detected at diagnosis. All five patients with persistent HPV16 experienced disease recurrence, with three eventually dying of their cancer. Conversely, only nine of 119 patients without persistent oral HPV16 DNA developed recurrent disease. "Our findings indicate that persistent HPV16 DNA in oral rinses may be a useful early marker of disease that has either recurred or never fully responded to treatment," said first author Eleni Rettig, MD, of the Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland. "In the clinical setting, this could one day be a part of routine surveillance after treatment for HPV-positive oropharyngeal cancers, in addition to clinical examination and imaging," she told Medscape Medical News. The study was published online July 30 in JAMA Oncology. Biomarker Potential? In an accompanying editorial, Julie E. Bauman, MD, MPH, and Robert L. Ferris, MD, PhD, both of the University of Pittsburgh, in Pennsylvania, [...]

Leaders in Dentistry: Dr. Ezra Cohen

Source: Dr. Bicuspid By: Donna Domino, Features Editor Date: July 17, 2013 May 21, 2013 — DrBicuspid.com is pleased to present the next installment of Leaders in Dentistry, a series of interviews with researchers, practitioners, and opinion leaders who are influencing the practice of dentistry. We spoke with Ezra Cohen, MD, an associate professor of medicine and the co-director of the head and neck cancer program at the University of Chicago, and the associate director for education at the university’s Comprehensive Cancer Center. Dr. Cohen specializes in head and neck, thyroid, and salivary gland cancers, and is an expert in novel cancer therapies who has conducted extensive research in molecularly targeted agents in the treatment of these cancers. His research interests include discovering how cancers become resistant to existing treatments and overcoming these mechanisms and ways to combine radiotherapy with novel agents. Here Dr. Cohen discusses trends in the incidence, detection, and treatment of oral and head and neck cancers. DrBicuspid.com: What’s the significance of your recent finding that there may be five distinct subgroups of the human papillomavirus (HPV)? Dr. Cohen: The purpose of the research was trying to define molecular subgroups of head and neck cancer (HNC) to inform therapy and outcomes a lot more than we do now as defined by stage and anatomic site. We were taking advantage of a cohort of patients that we treated in a similar fashion at the University of Chicago with a chemotherapy regimen that we commonly use here. The patients [...]

2013-07-19T07:48:02-07:00July, 2013|Oral Cancer News|

Sharp rise in HPV-related oropharyngeal carcinoma — a legacy of the “sexual revolution”?

Source: MedScape Author: Zosia Chustecka March 30, 2010 — The incidence of oropharyngeal carcinoma related to human papillomavirus (HPV) has been increasing in recent years, and there is speculation that this is the result of the "sexual revolution" of the 1960s. This increase in the incidence of HPV-related oropharyngeal cancer has important public health implications, British experts warn in an editorial published online March 25 in the British Medical Journal. HPV-related oropharyngeal carcinoma appears to be a new and distinct disease entity, with better survival than the classic non-HPV-related disease, they point out. "These patients are typically younger and employed, and — because outcomes seem to be more favorable than for patients with non-HPV-related carcinoma — they will live longer with the functional and psychological sequelae of their treatment. Consequently, they need prolonged support from health, social, and other services, and may require help returning to work," write the authors, headed by Hisham Mehanna, BMedSc, MB ChB, FRCS, director of the Institute of Head and Neck Studies and Education at University Hospital in Coventry, United Kingdom. However, currently, there is no good evidence to support managing patients with HPV-related head and neck cancer differently from those whose tumors are not HPV-related, the researchers write. Several studies are being planned to evaluate different treatment options, and Dr. Mehanna and colleagues urge clinicians to offer all patients with oropharyngeal cancer the opportunity to enroll in a clinical trial. However, until data from those trials are available, "we suggest that clinicians should not change their current [...]

2010-06-18T08:06:16-07:00June, 2010|Oral Cancer News|

Sharp rise in HPV-related oropharyngeal carcinoma — a legacy of the “sexual revolution”?

Source: MedScape Today Author: Zosia Chustecka March 30, 2010 — The incidence of oropharyngeal carcinoma related to human papillomavirus (HPV) has been increasing in recent years, and there is speculation that this is the result of the "sexual revolution" of the 1960s. This increase in the incidence of HPV-related oropharyngeal cancer has important public health implications, British experts warn in an editorial published online March 25 in the British Medical Journal. HPV-related oropharyngeal carcinoma appears to be a new and distinct disease entity, with better survival than the classic non-HPV-related disease, they point out. "These patients are typically younger and employed, and — because outcomes seem to be more favorable than for patients with non-HPV-related carcinoma — they will live longer with the functional and psychological sequelae of their treatment. Consequently, they need prolonged support from health, social, and other services, and may require help returning to work," write the authors, headed by Hisham Mehanna, BMedSc, MB ChB, FRCS, director of the Institute of Head and Neck Studies and Education at University Hospital in Coventry, United Kingdom. However, currently, there is no good evidence to support managing patients with HPV-related head and neck cancer differently from those whose tumors are not HPV-related, the researchers write. Several studies are being planned to evaluate different treatment options, and Dr. Mehanna and colleagues urge clinicians to offer all patients with oropharyngeal cancer the opportunity to enroll in a clinical trial. However, until data from those trials are available, "we suggest that clinicians should not change their [...]

2010-04-01T19:38:46-07:00April, 2010|Oral Cancer News|
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