Researchers from Belgium have reported that Sutent® (sunitinib) benefits one-third of patients with advanced malignant melanoma who have previously failed dacarbazine-based chemotherapy. The details of this Phase II study were presented at the Joint ECCO 15 – 34^th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.[1]

Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, VEGF, and PDGF receptors that is currently in clinical trials for treatment of a variety of malignancies. It produces anticancer effects through targeted mechanisms that include anti-angiogenesis, as well as direct killing of the cancer cell. In Phase I-II studies, Sutent is approved by the U.S. Food and Drug Administration for treating renal cell carcinoma and gastrointestinal stromal tumors that have progressed after Gleevec® (imatinib mesylate).  More recent studies have suggested that Sutent is active for the treatment of pancreatic islet cell cancer, breast cancer, and non–small cell lung cancer.

Another oral kinase inhibitor, Nexavar® (sorafenib), has been shown to improve progression-free survival in patients with advanced melanoma receiving dacarbazine.

The current study included 21 patients with locally advanced or metastatic melanoma whose disease had failed at least one line of dacarbazine-based chemotherapy. Three patients had Sutent discontinued due to adverse events. Two patients had a partial response that lasted 5.4 months. Five patients had stable disease (27.8%) with a mean duration of 4.4 months. The most common toxicities were asthenia, anorexia, and nausea. These authors will correlate response to kinase receptor status.

Comments: This study and the previous study of Nexavar suggest a role for targeted therapy for some patients with malignant melanoma.  This is a potentially important finding because response to traditional chemotherapy in melanoma is extremely poor.

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