The herpes simplex virus, known as OncoVEX and owned by BioVex Inc, had been modified so it multiplies inside cancer cells but not healthy cells. It bursts and kills tumour cells and, by expressing a human protein, it also helps stimulate patients’ immune systems.
The virus was injected into 17 patients’ cancer-affected lymph nodes in up to four doses, and the patients were also given radiotherapy and chemotherapy. Head and neck tumour shrinkage could be seen on scans for 14 patients (82.3%), while 93 per cent of patients had no trace of residual cancer in their lymph nodes during subsequent surgery to remove them. After an average follow-up time of 29 months (19 to 40 months), 82.4 per cent of patients had not succumbed to the disease. Only two of 13 patients given the virus treatment at a high dose relapsed.
“Around 35 to 55 per cent of patients given the standard chemotherapy and radiotherapy treatment typically relapse within two years, so these results compare very favourably,” Principal Investigator Dr Kevin Harrington from the ICR and The Royal Marsden says. “This was a small study so the results should be interpreted with caution; however the very high rates of tumour response have led to the decision to take this drug into a large scale Phase III trial. This will be the first ever phase III trial combining virus therapy with curative chemoradiation.”
Side-effects were generally mild to moderate, and most – except fever and fatigue – were thought to be due to the chemotherapy or radiotherapy. OncoVEX has previously shown promising results when administered on its own in early stage trials of patients with other cancer types, including a Phase II trial of metastaic melanoma patients.
“This trial showed for the first time that these oncolytic viruses can be safely used in combination with other cancer treatments given with the intention of curing patients,” Dr Harrington says.
Around 650,000 people are diagnosed with squamous cell cancer of the head and neck each year worldwide, and around 350,000 die from the disease annually.
Media Contact: ICR Science Press Officer Jane Bunce on 0207 153 5106
Notes to editors:
A Phase III trial of OncoVEX in combination with chemoradiation for newly diagnosed head and neck cancer patients – who have not yet received any treatment – is expected to begin recruitment later this year. A Phase III trial of OncoVEX for melanoma patients is currently recruiting. For more information about this and other trials please visit www.cancerhelp.org.uk or www.clinicaltrials.gov or contact The Royal Marsden’s Patient Advice and Liaison Service on 0800 783 7176.
Phase I/II Study of Oncolytic HSVGM-CSF in Combination with Radiotherapy and Cisplatin in Untreated Stage III/IV Squamous Cell Cancer of the Head and Neck will be published in Clinical Cancer Research on August 1 2010;16 4005-4015 http://clincancerres.aacrjournals.org/cgi/content/abstract/16/15/4005
The Institute of Cancer Research (ICR)
- The ICR is Europe’s leading cancer research centre
- The ICR has been ranked the UK’s top academic research centre, based on the results of the Higher Education Funding Council’s Research Assessment Exercise
- The ICR works closely with partner The Royal Marsden NHS Foundation Trust to ensure patients immediately benefit from new research. Together the two organisations form the largest comprehensive cancer centre in Europe
- The ICR has charitable status and relies on voluntary income, spending 90 pence in every pound of total income directly on research
- As a college of the University of London, the ICR also provides postgraduate higher education of international distinction
- Over its 100-year history, the ICR’s achievements include identifying the potential link between smoking and lung cancer which was subsequently confirmed, discovering that DNA damage is the basic cause of cancer and isolating more cancer-related genes than any other organisation in the world
- The ICR is home to the world’s leading academic cancer drug development team. Several important anti-cancer drugs used worldwide were synthesised at the ICR and it has discovered an average of two preclinical candidates each year over the past five years
For more information visit www.icr.ac.uk
The Royal Marsden was the first hospital in the world dedicated to cancer treatment and research into the causes of cancer. Today, as The Royal Marsden NHS Foundation Trust, together with its academic partner The Institute of Cancer Research, form the largest comprehensive cancer centre in Europe with over 40,000 patients from the UK and abroad seen each year. It is a centre of excellence, and the only NHS Trust to achieve the highest possible ranking in the Healthcare Commission’s Annual Health Check for the fourth year in a row.
For further information please contact Naomi Owen on 0207 808 2107 or email [email protected]