For more than 50 percent of patients with metastatic melanoma with V600 mutations in the serine-threonine protein kinase B-RAF (BRAF V600-mutant metastatic melanoma), treatment with vemurafenib is associated with clinical response, according to a phase 2 trial published in the Feb. 23 issue of the New England Journal of Medicine.
Jeffrey A. Sosman, M.D., from the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and colleagues investigated the efficacy of vemurafenib with respect to overall response rate, duration of response, and overall survival for 132 patients with previously treated BRAF V600-mutant metastatic melanoma. Patients were followed for a median of 12.9 months.
The researchers found that the overall response rate was 53 percent, including 6 percent with a complete response and 47 percent with a partial response. The median duration of response and median progression-free survival were 6.7 and 6.8 months, respectively, and median overall survival was 15.9 months. Only 14 percent of patients were seen to experience primary progression. Some patients had a response only after receiving vemurafenib for more than six months.
"This trial shows a high rate of response to vemurafenib in patients with metastatic melanoma and activating BRAF mutations," the authors write. "The long follow-up period in our study provides critical information on long-term overall survival, not yet shown in the phase 3 trial comparing vemurafenib with dacarbazine."
The study was funded by Hoffmann-La Roche, which manufactures vemurafenib; several authors disclosed financial relationships with pharmaceutical companies, including Hoffmann-La Roche.
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