Selumetinib fails Phase III trial in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic NSCLC.- AstraZeneca

AstraZeneca announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC).The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.

Comment;A randomised Phase II trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation-positive NSCLC. However these results have not been confirmed in Phase III.