Fast Track Designation to Etirinotecan Pegol (NKTR-102) for Metastatic Breast Cancer

Nektar Therapeutics announced that the FDA has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC) (Xeloda; Roche).  Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed using proprietary polymer conjugate technology. .

The drug candidate is being evaluated in a Phase 3 study in women with metastatic breast cancer. The BEACON Study ( B r EA st C ancer O utcomes with N KTR-102) will enroll approximately 840 metastatic breast cancer patients who have had prior treatment with ATC in either the adjuvant or metastatic setting. The primary endpoint of the BEACON study is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective tumor response rates (ORR), clinical benefit rate, duration of response, pharmacokinetic (PK) data, safety, quality-of-life measurements, and measurement of healthcare resource utilization for the two study arms. Exploratory objectives of the study include collecting specific biomarker data which will be correlated with efficacy outcome measures. Enrollment in the BEACON study began in December 2011 and is expected to be completed by the end of 2013.