Array BioPharma Inc. (NASDAQ: ARRY) today announced results from a randomized Phase 2 placebo-controlled study conducted by AstraZeneca comparing the efficacy of selumetinib (AZD6244/ARRY-886) in combination with docetaxel with docetaxel alone in the second-line treatment of 87 patients prospectively selected with KRAS-mutant, locally advanced or metastatic non-small cell lung cancer. This was the first completed randomized combination trial with a MEK inhibitor. Selumetinib was licensed from Array to AstraZeneca.
The study's primary endpoint of overall survival demonstrated a numerically greater increase in survival in favor of selumetinib in combination with docetaxel versus docetaxel alone, but did not reach statistical significance.
The key secondary endpoints of progression-free survival, objective response rate, and alive and progression-free at 6 months were all demonstrated with statistical significance, showing improvement in favor of selumetinib in combination with docetaxel versus docetaxel alone.
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