Nektar Therapeutics has initiated a phase III global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON study is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting.
BEACON is a phase III, open-label, randomized, multicenter study of NKTR-102 and will be conducted in approximately 160 sites worldwide including North America, Eastern and Western Europe, and certain countries in Asia/Pacific. Patients will be 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 will include: ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane. Randomization will be stratified by geographic region, prior use of eribulin and receptor status.
The primary endpoint of the BEACON study will be overall survival, and secondary endpoints will include progression-free survival and objective tumor response rates. Secondary endpoints also include clinical benefit rate, duration of response, PK data, safety profiles, quality-of-life measurements, and pharmacoeconomic implications. Exploratory objectives of the study will include collecting specific biomarker data to correlate with objective tumor response rates, progression-free survival, overall survival and selected toxicities.
