- Randomized, Phase II study (N = 87) of 2nd-line selumetinib/docetaxel vs docetaxel
- Modest efficacy advantage observed (median OS 9.4 vs 5.2 mo [nonsignificant], median PFS 5.3 vs 2.1 mo)
- Higher rates of nonhematologic and hematologic AEs with selumetinib
Approximately 25% of all adenocarcinomas of the lung have KRAS mutations, which were previously considered difficult or impossible to treat. However, this randomized Phase II study suggests that the novel MEK inhibitor selumetinib — which inhibits MEK1/2 kinases downstream of KRAS — may have preferential activity in this subset of patients when combined with docetaxel. In the trial, progression-free survival was increased significantly, and objective partial responses were observed in more than a third of patients receiving the combination but none were observed in the docetaxel-alone arm. For that reason, this data set has generated interest in studying selumetinib in a Phase III study, but it has also raised the hope that additional targeted agents may be developed in the future with greater activity in patients with these mutations.
