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AstraZeneca Initiates Phase 3 Clinical Trial For Selumetinib In Non-Small Cell Lung Cancer
Date:10/22/2013

BOULDER, Colo., Oct. 22, 2013 /PRNewswire/ -- AstraZeneca today announced the first patient randomized in a Phase 3 clinical trial 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.  

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Array BioPharma (NASDAQ:   ARRY) invented and licensed worldwide rights to develop and commercialize selumetinib to AstraZeneca in 2003.  The initiation of the Phase 3 trial triggered a $5 million milestone payment to Array.  Array retains significant economic rights to selumetinib under the agreement with AstraZeneca, including double digit royalties on global commercial sales and the potential for approximately $70 million in additional milestone payments. 

Ron Squarer, Chief Executive Officer, Array BioPharma noted, "The initiation of the Phase 3 SELECT-1 trial highlights AstraZeneca's on-going commitment to develop selumetinib broadly in areas of high unmet need.  Together with the active pivotal trial in thyroid cancer and the announced uveal melanoma trial, there are already three paths to market for selumetinib."

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) as the primary endpoint and Overall Survival (OS) as a secondary endpoint. AstraZeneca has reported that SELECT-1 will include 220 centers globally and enroll 634 patients, who will be randomized in a rati
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SOURCE Array BioPharma
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