AstraZeneca initiates Phase III lung cancer trial after positive PII results

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has initiated its Phase III clinical program for selumetinib, an oral, potent, selective MEK inhibitor, being investigated as second-line therapy in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors are KRAS mutation-positive.

The SELumetinib Evaluation as Combination Therapy-1 (SELECT-1) study is a randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of selumetinib plus docetaxel as a second line therapy in locally advanced or metastatic KRAS mutation-positive NSCLC. The study is designed to evaluate progression free survival (PFS) and overall survival (OS). SELECT-1 will be the largest prospective study ever conducted in this patient population, a genetic sub-type of lung cancer associated with poor prognosis and limited treatment options.

The decision to progress selumetinib to Phase III studies in NSCLC followed the results from Study 16, a randomized Phase II study evaluating the combination of selumetinib with standard of care docetaxel against docetaxel alone in KRAS-mutation positive NSCLC. AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma (Nasdaq: ARRY) in 2003.