Nektar Therapeutics has completed enrolment in Phase III BEACON Study of topoisomerase I inhibitor, etirinotecan pegol (NKTR-102), in women with metastatic breast cancer.
In the open-label, randomised, multicentre study, etirinotecan pegol will be evaluated against a single-agent treatment of physician’s choice for the treatment of locally recurrent or metastatic breast cancer.
Nektar senior vice-president and chief medical officer Dr Robert Medve said: "The primary endpoint in the BEACON study is survival and as we have previously announced, we plan to conduct an interim futility analysis for the BEACON study in the first quarter of next year with topline survival data to be available around the end of 2014."
Conducted at approximately 150 sites globally, including North America, Eastern and Western Europe, and certain countries in Asia/Pacific, the study will include around 840 women with locally recurrent or metastatic breast cancer and previously treated with anthracycline, taxane or capecitabine treatments.
The subjects will be randomised with 145mg/m² of single-agent etirinotecan pegol once every three weeks or a single agent of physician’s choice such as ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane in 1:1 ratio.
The study’s primary endpoint is overall survival, and secondary endpoints are progression-free survival, objective tumour response rates, clinical benefit rate, duration of response, PK data, safety profiles, quality-of-life measurements and pharmacoeconomic implications.
In addition, specific biomarker data will also be evaluated to assess correlation with objective tumour response rates, progression-free survival, overall survival and selected toxicities.
Image: Mammograph of normal (left) versus cancerous (right). Photo: courtesy of the National Cancer Institute.