Sosman and colleagues evaluated the overall response rate, duration of response, and overall survival of vemurafenib in previously treated patients with BRAF V600 mutant-metastatic melanoma.22 In this multicenter, Phase 2 trial, 132 patients received vemurafenib 960mg orally twice daily until the development of unacceptable adverse effects or disease progression. Patients with disease progression could continue with vemurafenib if it was thought that the patient would benefit clinically. Median follow-up was 12.9 months with a range of 0.6 to 20.1 months. The confirmed overall response rate was 53%, with 6% experiencing a complete response, and 47% experiencing a partial response. The median duration of response was 6.7 months and median progression-free survival was 6.8 months. Primary disease progression was only observed in 14% of treated patients. Response was not necessarily observed right away. Some patients did not start to experience a response until 6 months after treatment started. The median overall survival was 15.9 months. Vemurafenib appeared to be well tolerated. The more commonly reported adverse effects included grade 1 or 2 arthralgia, rash, photosensitivity, fatigue, and alopecia. This clinical trial was able to demonstrate that vemurafenib can induce clinical responses in previously treated patients with BRAF V600 mutant-metastatic melanoma over an extended period of time (16 months).
The search for safe and effective advanced melanoma cancer treatment therapies has been a long and difficult struggle. The introduction of ipilimumab and vemurafenib may be the beginning of the identification of melanoma treatment options that improve survival outcomes based upon patient immune response.
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