Vemurafenib provided meaningful clinical benefit to Spanish patients with BRAF V600 mutation-positive metastatic melanoma

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  • Vemurafenib is beneficial in patients with BRAF V600 mutation-positive metastatic melanoma, including older patients and those with comorbidities, brain involvement, and poor performance status—a population representative of patients seen in real-life clinical practice.
Study design
  • An open-label, single-group, multicenter study of 301 patients with previously treated or treatment-naive, unresectable stage IIIC or stage IV BRAF V600 mutation-positive melanoma.
  • Patients received vemurafenib, 960 mg twice daily, until disease progression, unacceptable toxicity, withdrawal of consent, or death.
  • The primary endpoint was safety; secondary endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).
Key results
  • 70% had M1c disease, 22% had brain metastases, and 51% had prior systemic therapy for metastatic disease.
  • Most frequent adverse events included fatigue (48%), arthralgia (45%), rash (41%), photosensitivity (34%), a...