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About half of all melanomas are driven by a mutation in the B-RAF gene, called V600 → E. So in 2009, when early small trials showed many patients with the mutation responding to a drug called PLX4032, researchers were jubilant. The drug is now in a pivotal phase III trial for metastatic melanoma; there is talk about accelerated approval; and its developers, Plexxikon and Roche, have already opened an expanded access program. The only bad news about PLX4032 so far is the duration of response: Patients are developing resistance to the small-molecule inhibitor in 2 – 18 months. Phase II trial results, announced in November, showed that 52% of patients with the mutation responded to PLX4032, but the median duration of response was 6.2 months.

Getting Around PLX4032: Studies Turn Up Unusual Mechanisms of Resistance to Melanoma Drug