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Early-phase melanoma study adds to "Melanoma" ASCO

BY ELIZABETH WHITTINGTON
PUBLISHED SUNDAY, JUNE 5, 2011
To add to what appears will be a melanoma-focused ASCO meeting (American Society of Clinical Oncology) this year, a phase 1/2 trial of a combination of experimental targeted agents looks to be generating interest as well.

On Saturday, researchers revealed that two targeted therapies, still going by their compound names of GSK212 and GSK436 (both are developed by the same company, GSK), worked synergistically together against metastatic melanoma.

GSK436 works against the same mutated BRAF gene that vemurafenib does (which you will hear about later in the meeting and the summer issue of CURE). The other agent works against MEK.

While BRAF inhibitors appear to have success against melanoma, the researcher presenting the data, Jeffrey Infante, MD, says the effects isn't durable, which is where the MEK inhibitor comes in. The combination had a high response rate (81 percent), either reducing tumor size or preventing future tumor growth in many patients.

Another interesting aspect of the trial is that when combined, the two drugs seem to have fewer side effects, including reduced incidence of squamous cell carcinoma and an acne-like rash. Infante said they weren't quite sure why the combination produced less side effects, but it could be because BRAF and MEK are on the same signaling pathway.

The next step of the trial is to continue accruing patients in the phase 2 portion of the study to continue looking at the best possible dose, including different doses for GSK436 with GSK212 and GSK212 alone. Infante says the trial is accruing quickly and he expects to finish enrollment of 150 patients in just a couple of months.

The study highlights that combinations could be key to melanoma progress. Add to it the recent news of two major drug companies' unique collaboration on a study combining newly approved Yervoy and experimental drug, vemurafenib, the field of melanoma is receiving the attention so many melanoma patients desperately need.

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