"There are some important caveats. All these patients had failed previous therapies, either chemotherapy or treatment with Interleukin 2, as well as surgery. However, we know that only 10-30% of patients will respond to standard chemotherapy, so it's not surprising that our patients had not responded, or have responded and then the cancer has recurred. In our study 64% of patients have had a partial response, but because we are only treating patients with the BRAF mutation, we are cutting out about 40% of melanoma patients who do not have this mutation and whom we know will not respond to this treatment. That is one reason why we are seeing a much higher response than with conventional treatments.
"Also, we don't know yet how long these responses will last, and we have had patients whose cancer has progressed after initially responding; so we are putting a lot of effort in to studying the patients who do relapse, trying to understand how their tumours have become resistant.
"In addition, one of the main side effects we've seen is that some patients develop early, non-melanoma skin cancers such as squamous cell skin cancer. We are very vigilant about this and although they are very easy to cut out, it's something we are keeping a close eye on."
Dr Chapman and his colleagues are planning a phase II trial of 90 patients starting at the end of this year. In addition, a large phase III randomised controlled trial involving several hundred patients is planned to start either at the end of this year or beginning of next year involving centres in North America, Europe and Australia.
Dr Chapman said it was too early to be talking about a cure for advanced melanoma, but that this drug had potential. "Most of us think that a drug like this would ultimately be part of the regimen, but that we might need additional drugs with it to complete the cure. Right now we are seeing dramatic responses but it's too early to say whether we've actually cured people because most patients still have evidence of some level of tumour on their skin. I think this is a huge step forward; whether or not it will be sufficient by itself really remains to be seen."
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