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AstraZeneca's (AZN) Tagrisso Hits Phase III Primary Endpoint

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AstraZeneca plc AZN announced that its lung cancer drug, Tagrisso, met the primary endpoint in a randomized phase III study (AURA3). The study evaluated the efficacy and safety of Tagrisso as a second-line treatment of patients suffering from EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose disease had progressed following first-line EGFR tyrosine kinase inhibitor therapy.

Results showed that Tagrisso demonstrated superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy with a safety profile that was found to be consistent with previous studies. In addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy.

Meanwhile, full evaluation of AURA3 study data including an analysis of overall survival is currently ongoing and the company intends to present the data at an upcoming medical meeting.

We are encouraged by the phase III study results. We note that Tagrisso is currently approved in both the U.S. and EU for the treatment of patients with EGFR T790M mutation-positive advanced NSCLC. It is the first drug to be approved for this indication. Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumor.

Initial sales of the drug have been encouraging reflecting increased testing rates, which have been driving the number of new-patient starts.

Currently, Tagrisso is also being evaluated in the adjuvant and metastatic first-line settings, including patients with and without brain metastases, in leptomeningeal disease, and in combination with other treatments.

AstraZeneca is working on strengthening its oncology product portfolio and has several candidates in its pipeline. The company’s target is to launch at least six new medicines between 2014 and 2020.

AstraZeneca is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY, Innoviva, Inc. (INVA - Free Report) and Fibrocell Science, Inc. FCSC. All three stocks sport a Zacks Rank #1 (Strong Buy).

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