Authors' objectives: Pelareorep (Reolysin) is intended to be used as second line therapy for the treatment of metastatic or recurrent squamous cell carcinoma of the head and neck. If licensed, it would offer an additional treatment option for this patient group who currently have few well-tolerated effective therapies available. Pelareorep is a ubiquitous, non-enveloped, double-stranded RNA virus that can selectively target and replicate inside tumour cells that have an activated Ras pathway, thereby killing these cells. Pelareorep does not currently have Marketing Authorisation in the EU for any indication. Head and neck cancer can occur in over 30 specific sites including the lips, mouth, tonsils and throat. Whilst incidence is low for individual sites, collectively they pose a large healthcare burden. The annual incidence of head and neck cancer is estimated to be 0.022% and 0.009% for males and females, respectively, equating to approximately 8,000 cases in England each year. Incidence increases with age, with around 85% of head and neck cancers occurring in people over 50 years of age. Approximately 60% of patients present with locally advanced disease at diagnosis and the majority of these develop local and/or regional recurrence, with approximately 20-30% developing distant metastases. Epidermal growth factor receptor is overexpressed in approximately 80% of head and neck squamous cell carcinomas and is associated with poor survival. Treatment options for squamous cell carcinoma of the head and neck vary according to the specific sites involved, however in general treatment options include surgery, radiotherapy and chemotherapy; additionally cetuximab may be used in combination with radiotherapy for patients with locally advanced disease. Pelareorep in combination with chemotherapy has completed a phase III clinical trial comparing its effect on overall survival against treatment with chemotherapy alone.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/pelareorep-reolysin-in-combination-with-chemotherapy-for-metastatic-or-recurrent-squamous-cell-carcinoma-of-the-head-and-neck-second-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Centre (NIHR HSC)