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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

advanced breast cancer, particularly for patients with HER2-negative breast cancer and triple-negative breast cancer." 

Positive Phase 2 data for NKTR-102 were recently published in Lancet Oncology in November 2013. (1)  Etirinotecan pegol achieved a confirmed objective response rate by RECIST of 29 percent. NKTR-102 demonstrated a high clinical benefit rate (CR+PR+SD greater than six months) of 37 percent (13/35) in the 14-day group and 49 percent (17/35) in the 21-day group. Six patients experienced 100 percent resolution of all target lesions, with two complete RECIST responses and four near-complete responses.
Patients treated exhibited low rates of alopecia, neuropathy and neutropenia, which are significant adverse events associated with existing breast cancer therapies. Side effects were generally manageable; the most common Grade 3 toxicity was diarrhea (17-23%) typically occurring after three months of therapy.

About the BEACON StudyBEACON is a Phase 3, open-label, randomized, multicenter study of NKTR-102 which enrolled 852 women with locally recurrent or metastatic breast cancer, who have previously been treated with ATC. The trial is being conducted at approximately 150 sites worldwide including North America, Western Europe, Russia and the Republic of Korea.  Nearly half of the patients enrolled in BEACON were located in North America.  Patients were randomized on a 1:1 basis to receive 145 mg/m2 of single-agent NKTR-102 once every three weeks or a single agent of physician's choice.  The physician's choice agents include: ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane.  Randomization was stratified by geographic region, prior use of eribulin and receptor status. 

The primary endpoint of the BEACON study is overall survival; secondary endpoints include progression-free survival, objective tumor response
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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
2. Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3 BEACON Study of Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer at the 2013 American Society of Clinical Oncology Annual Meeting
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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