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Etirinotecan Pegol (NKTR-102) Passes Interim Efficacy Analysis for BEACON Pivotal Phase 3 Clinical Study in Patients with Metastatic Breast Cancer
Date:1/14/2014

SAN FRANCISCO, Jan. 14, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) announced today that the Independent Data Monitoring Committee (DMC) created to provide safety oversight for the Company's pivotal clinical study for etirinotecan pegol (NKTR-102) has recommended continuation of the BEACON phase 3 trial, based upon the completion of a planned interim efficacy analysis in accordance with the DMC charter.  The BEACON trial is evaluating NKTR-102 versus an agent of physician's choice for the treatment of locally recurrent or metastatic breast cancer, with a primary efficacy endpoint of overall survival. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle, and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

The independent DMC performed the pre-defined interim efficacy analysis, which consisted of a review of ongoing efficacy and safety data, including 50% of patient events necessary to evaluate the primary endpoint of overall survival.  In August 2013, the BEACON study completed enrollment of 852 patients with advanced breast cancer whose disease has progressed following treatment with anthracycline, taxane and capecitabine therapies (ATC).

"While the results of BEACON remain blinded to Nektar, we are very pleased that the NKTR-102 trial has successfully passed this important interim efficacy analysis," said Howard Robin, President and CEO of Nektar Therapeutics.  "We expect final results from the study at the end of 2014 or early 2015, and if positive, we plan to submit filings in the U.S. and Europe in the second half of 2015. There is a high unmet need for new treatment options for patients with
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SOURCE Nektar Therapeutics
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1. Nektar Completes Enrollment in Phase 3 BEACON Study of Etirinotecan Pegol in Women With Metastatic Breast Cancer
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3. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
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