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Positive Results from Phase 2 Clinical Study of NKTR-102 in Metastatic Breast Cancer Presented in Oral Session at the ASCO 2011 Breast Cancer Symposium
Date:9/9/2011

, 71 percent of patients in the study had no tumor progression, defined as complete response (CR), partial response (PR) and stable disease (SD), as measured by RECIST criteria.  NKTR-102 also demonstrated a high clinical benefit (CR+PR+SD greater than six months) rate of 46 percent (30 of 66).  Six patients experienced 100 percent resolution of all target lesions, with two complete RECIST responses and four near-complete responses. Objective tumor responses were maintained in heavily pretreated and poor prognosis subsets, including patients previously treated with anthracycline/taxane/capecitabine, patients with metastatic triple-negative breast cancer and patients with visceral disease.  

NKTR-102 exhibited minimal alopecia, neuropathy and neutropenia, which are significant adverse events associated with existing and recently-approved breast cancer therapies.  Side effects were generally manageable; most common Grade 3 toxicity was diarrhea (17-23%) typically occurring after three months of therapy for both schedules.  

Eighty-nine percent (62/70) of patients in the study received a prior anthracycline/taxane with or without capecitabine.  A total of 66 of the 70 patients treated with single-agent NKTR-102 in the Phase 2 clinical study were assessable for the primary endpoint of objective tumor response rate (ORR).  

The slide presentation from today's oral session at the ASCO 2011 Breast Cancer Symposium is available on Nektar's website at http://www.nektar.com/product_pipeline/oncology_nktr-102.html.BEACON Study DesignThe company also announced today the design of the planned Phase 3 clinical trial of NKTR-102 in metastatic breast cancer patients.  The BEACON study (BrEAst Cancer Outcomes with NKTR-102) plans to enroll approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane
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SOURCE Nektar Therapeutics
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