Personalized medicine: Roche success in skin cancer clinical trial
Roches potential first-in-class drug could be a crucial milestone in personalized medicine
Roche announced that its novel personalized drug for advanced malignant melanoma, RG7204, has showed a statistically significant survival benefit over the conventional therapy in a Phase III clinical trial.
Malignant melanoma is the most deadly form of skin cancer.
It arises in the melanocytesskin cells that produce the dark pigment, melaninand when it is detected at an advanced stage fewer than 10% of patients survive five years.
The drug RG7204, which was originally developed by Berkeley, CA-based biotech company Plexxikon with the code name PLX4032, selectively inhibits the mutated and over-active form of the enzyme BRAF, which is found in about half of all melanoma patients.
This drug, which is a potential first-in-class, is being developed along with a diagnostic test to identify patients who carry this mutation.
RG7204 was tested in the BRIM3 clinical trial in comparison to the notoriously ineffective current standard of care for melanoma, the chemotherapy drug dacarbazine.
Its results so far are unambiguous: melanoma patients with BRAF mutations who received RG7204 lived longer before their cancer progressed, and lived longer altogether, than those who received the control drug.
Most side effects were mild and easily controlled.
The final results of this trial will not be presented until later this hear, but Roche has now agreed that patients on the control arm of the study may, if they wish, move over and start taking RG7204.
But this was not before the study caused controversy over the ethics of continuing the control arm of a trial once the investigational drug has showed significant benefit.
This controversy even reached the New York Times, which ran a story of two cousins randomized to different arms of the trial in September 2010.
These are complex ethical questions that will require further discussion.
In the meantime, though, Roches strategy of developing drugs to target tumors with specific mutations is paying offwhich bodes well for the future of personalized medicine.
To hear Roche discuss RG7204, and for all the latest advances in personalized medicine, join the sectors key players at Personalized Medicine & Diagnostics Europe on March 9 and 10 in London.