Phase 2 Study of Selumetinib for KRAS Mutant Advanced NSCLC

Array BioPharma announced promising data from a double-blind, randomized Phase 2 study conducted by AstraZeneca comparing the efficacy of selumetinib (AZD6244/ARRY-886) in combination with Taxotere (docetaxel; Sanofi Aventis) vs. docetaxel alone in 87 second-line patients with KRAS mutation positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

The study showed statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as a trend for improvement in overall survival in favor of selumetinib in combination with docetaxel versus docetaxel alone. Overall survival was longer for selumetinib in combination with docetaxel compared to docetaxel alone (9.4 months vs 5.2 months; 56 events, median follow-up 219 days) but did not reach statistical significance. Hazards were non-proportional (HR 0.8; 80% CI 0.56, 1.14; 1-sided P=0.2069). All secondary endpoints, including response rate (selumetinib/docetaxel 37%, docetaxel 0%; P<0.0001) and progression free survival (selumetinib/docetaxel 5.3 months, docetaxel 2.1 months; 71 events; HR=0.58; 80% CI 0.42, 0.79; 1-sided P=0.0138), were significantly improved for selumetinib in combination with docetaxel vs. docetaxel alone.

Selumetinib is a small molecule mitogen-activated protein kinase (MEK) inhibitor. MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which signals cancer cell proliferation and survival. It is frequently present in advanced cancers that contain mutations in this pathway.

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