Amgen cold sore virus drug shows ‘significant’ cancer benefit
pharmafile | May 27, 2015 | News story | Research and Development, Sales and Marketing | Amgen, Cancer, cold sore, t-vec
Amgen is pinning its hopes on investigational viral treatment T-VEC following promising results from a ‘landmark’ skin cancer study.
People with melanoma who were treated with its T-VEC (talimogene laherparepvec) showed an improvement after six months in a trial led by researchers at the Institute of Cancer Research (ICR) and the Royal Marsden – one of the world’s leading cancer research hospitals.
T-VEC is a modified form of the cold sore virus – herpes simplex virus type-1 – that has been genetically engineered to produce a molecule called GM-CSF. This stimulates the immune system to attack and destroy tumours.
T-VEC is the first of a new wave of virus-based drugs to show a definitive benefit in a Phase III trial, although in a previous Phase III study it had reduced the size of tumour lesions.
In the latest study comprising 436 patients with skin cancer, 16.3% of people given T-VEC showed a durable treatment response of more than six months, compared with 2.1% of those given a control treatment. Some patients had a response extending past three years – a mark oncologists often use as a proxy for cure in immunotherapy.
Median overall survival just missed the benchmark for statistical significance, at 23.3 months for the T-VEC group and 18.9 months in the control group. People who had not previously had any treatment and those with early-stage melanoma showed the best response to treatment with the drug.
This prompted researchers to speculate that T-VEC could be a future first-line treatment for melanoma. Professor Kevin Harrington, professor of biological cancer therapies at The ICR who led the analysis in the UK, says: “Our study showed that T-VEC can deliver a significant, durable benefit for people with melanoma.
“It is encouraging that the treatment had such a clear benefit for patients with less advanced cancers – ongoing studies are evaluating if it can become a first-line treatment for more aggressive melanomas and advanced disease.
Amgen has already filed an FDA application for T-VEC with a decision expected in October, and it has logged it with the EMA. Executive vice president of R&D Sean Harper says the drug could be ‘an important new treatment option’.
“The trial data provide strong evidence supporting the local and distant effects of T-VEC and its potential to stimulate a systemic anti-tumour immune response”, he adds.
The potential of viral treatments for cancer is significant, ICR chief executive Professor Paul Workman says, who adds: “There is hope that therapies like this could be even more effective when combined with targeted cancer drugs to achieve long term control and cure.”
Gillian Nuttall, of the charity Melanoma UK, says: “Patients showing responses beyond three years is something that up until now, we could only have imagined.”
Lilian Anekwe
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