20 January 2011
A Royal Marsden NHS Foundation Trust led phase III study has met its co-primary endpoints of showing that RG7204 extends overall and progression-free survival compared to standard dacarbazine chemotherapy in patients with advanced malignant melanoma whose cancer has the BRAF genetic mutation1. This is the first time an investigational personalised medicine has been shown to extend the lives of patients with advanced melanoma – the most aggressive and deadliest form of skin cancer.
Based on the strength of trial results, Roche has amended the BRIM3 study to ensure that all trial patients who had been receiving standard chemotherapy (patients in the control arm of the study) will now be offered treatment with RG7204. The interim results will be presented at a major medical conference later this year and Roche will now begin discussing filing plans with global health authorities for licensing of RG7204.
Dr James Larkin, UK BRIM 3 lead researcher from The Royal Marsden, said: "This is an incredibly exciting breakthrough. Malignant melanoma is a very difficult disease to treat and with a growing incidence in younger people the results of this phase III trial are very encouraging."
Professor Richard Marais, whose work at The Institute of Cancer Research demonstrated the importance of BRAF in melanoma said: “These results represent a paradigm shift in melanoma treatment and will change how we approach treatment of this fatal disease.”
Over the past twenty-five years, rates of malignant melanoma in Britain have risen faster than any other common cancera. It is now the second most common cancer in young adults (aged 15-34) in the UK, affecting almost twice as many young women as young men, although men are more likely to die from it2. Approximately half of patients with advanced malignant melanoma have the BRAF genetic mutation3, which drives the cancer cells to grow and spread. The RG7204 pill targets and blocks the mutated BRAF protein, causing tumours to shrink.
In parallel with the development of RG7204, Roche and Plexxikon are developing a diagnostic test for the BRAF mutation, in order to identify patients whose cancer has the BRAF mutation and who may consequently benefit treatment with RG7204. The diagnostic test is not currently commercially available and RG7204 is not licensed for treatment of advanced melanoma.
-ENDS-
Editor’s Notes
About Advanced Melanoma and BRAF
Advanced melanoma is the deadliest and most aggressive form of skin cancer. A person with advanced melanoma typically has a short life expectancy that is measured in months. There are an estimated 2000 deaths annually in the UK from malignant melanoma, with young people disproportionately affected by the disease2. Over the last twenty-five years, rates of malignant melanoma in Britain have risen faster than any other common cancer2. If current trends continue, it is anticipated that there will be around 15,500 cases of malignant melanoma diagnosed per year within the next 15 years2. Until recently there has been no major advance in treatment for 30 years and patients with advanced melanoma have had very few treatment options.
The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Activating mutations in the BRAF gene cause this pathway to be overactive, which may lead to excessive growth and cancer. Mutations in the BRAF V600 protein are found in about 50 percent of melanomas and it is estimated that approximately eight percent of all solid tumours contain BRAF V600 mutations3.
About RG7204
RG7204 is an investigational, oral, small molecule that is designed to selectively inhibit a cancer-causing mutated form of the BRAF protein. RG7204 is being co-developed under a 2006 licence and collaboration agreement between Roche and Plexxikon. A polymerase chain reaction-based companion diagnostic, the cobas® 4800 BRAF V600 Mutation Test, is being co-developed by Roche Molecular Diagnostics and Plexxikon in parallel to identify people whose tumours carry the BRAF V600E mutation.
About Roche in the UK
Roche aims to improve people’s health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Further information at: www.rocheuk.com.
RG7204 is not licensed for the treatment of BRAF-mutated, advanced melanoma.
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For further information please contact:
Hannah Rhind
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1. Roche data on file.
2. Cancer Research UK. Skin cancer statistics – Key Facts. http://info.cancerresearchuk.org/cancerstats/types/skin/ (accessed January 2011).
3. TBC