Vemurafenib + fotemustin clinically active in BRAF-refractory melanoma

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  • The combination of vemurafenib plus fotemustine has clinical activity and manageable toxicity in patients with BRAF-mutated metastatic melanoma who experienced systemic progression while receiving single-agent BRAF inhibitor therapy.
Study design
  • Phase 2 single-group study conducted at 2 centers that investigated the activity of prolonged treatment with vemurafenib and the addition of fotemustine in patients with systemic progression while receiving a prior single-agent BRAF inhibitor.
  • 31 patients with BRAF-mutated unresectable stage IIIC or stage IV melanoma with systemic progressive disease while receiving single-agent vemurafenib treatment were included in the study.
Key results
  • 16 patients had brain metastases at enrollment into the trial.
  • Median PFS was 3.9 mo, and 19 patients (61.3%) achieved disease control; there was 1 complete respons...