Authors' objectives: Pelareorep (Reolysin) is intended to be used as second line therapy for the treatment of metastatic malignant melanoma, with or without chemotherapy. If licensed, it would offer an additional treatment option for patients with the disease 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. Over the last thirty years, rates of malignant melanoma in the UK have risen faster than any of the current ten most common cancers. The annual incidence of malignant melanoma is estimated at 0.02% in England, equating to just over 10,000 people diagnosed each year. More than one-third of all cases of malignant melanoma occur in people aged under 55. At presentation, 10% of cutaneous melanomas will have metastasised; metastatic disease is associated with extremely poor survival with a median survival of 6-10 months. Patients with metastatic stage IV melanoma or unresectable stage III melanoma are usually offered systemic therapy if they are well enough to tolerate it. Despite recent advances in treatment, the majority of patients will die prematurely from their disease. Therefore there is an ongoing need to identify new agents which could be incorporated into the treatment pathway for these patients. Non-surgical modalities including immunotherapy, chemotherapy, radiation therapy, or a combination of these treatments may be offered for inoperable stage III and IV disease. Two phase II clinical trials evaluating the effects of pelareorep on tumour response have been completed.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/pelareorep-reolysin-with-or-without-chemotherapy-for-metastatic-malignant-melanoma-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 Research&Intelligence Centre (NIHR HSRIC)