AstraZeneca Advances Selumetinib


AstraZeneca (AZN) has initiated a phase III program for its oncology candidate, selumetinib. The company is looking to get selumetinib approved as second-line treatment in patients, who suffer from advanced or metastatic non-small-cell lung cancer (:NSCLC) with KRAS mutation-positive tumors.

The SELECT-1 (SELumetinib Evaluation as Combination Therapy-1) study aims to enroll 634 NSCLC patients to compare the safety and efficacy of selumetinib in combination with Sanofi’s (SNY) Taxotere (docetaxel) to Taxotere and placebo. Results will be measured on the basis of progression free survival (PFS) and overall survival.

AstraZeneca advanced selumetinib into phase III studies on the basis of encouraging data from a randomized phase II study, Study 16, evaluating selumetinib plus Taxotere versus Taxotere alone in KRAS-mutation positive NSCLC. Statistically significant PFS was observed in the selumetinib plus Taxotere arm (5.3 months) as compared to Taxotere alone (2.1 months).

We remind investors that in 2003, AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma (ARRY).

Generic competition has been adversely impacting AstraZeneca’s revenues over the past few quarters. This has put significant pressure on the company.

In a bid to add late-stage candidates to its pipeline, AstraZeneca entered into a number of acquisition deals (Pearl Therapeutics and Omthera Pharmaceuticals) in the last few months and agreements with companies such as FibroGen, Inc.

AstraZeneca, a large-cap pharma company, presently carries a Zacks Rank #3 (Hold). Other large-cap pharma stocks such as Roche (RHHBY) looks well positioned with a Zacks Rank #1 (Strong Buy).

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