Phase 3 study of PLX4032 for the treatment of metastatic melanoma

Plexxikon announced positive data from its Phase 3 study of PLX4032 (RG7204) in patients with previously untreated metastatic melanoma with the BRAF mutation. This trial (known as the BRIM3 trial) is a global, randomized, open-label, controlled, multicenter study evaluating PLX4032 compared to dacarbazine (the current chemotherapy standard of care). In over 100 sites worldwide, 675 patients were randomized to receive either: PLX4032 960mg orally twice daily, or dacarbazine 1000mg/m2 intravenously every 3 weeks. Patients continue dosing until their disease progresses or there is unacceptable toxicity. Patients treated with PLX4032 had an improved overall survival (OS) compared to patients treated with dacarbazine. In addition, these patients lived longer on average without their disease getting worse, as measured by progression-free survival (PFS).

PLX4032 is an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation.

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