Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), and estrogen receptor 1 (ESR1) mutant locally advanced or metastatic breast cancer.
Design and Objectives of the ELAINE-3 Study
The open-label, randomized, controlled, multi-center Phase III study aims to assess the efficacy, safety, and tolerability of lasofoxifene in combination with abemaciclib compared to fulvestrant combined with abemaciclib. The study will enroll male and pre/post-menopausal female patients with ER+/HER2- locally advanced or metastatic breast cancer who have developed disease progression with ESR1 gene mutations after receiving aromatase inhibitors combined with palbociclib or ribociclib as first-line endocrine therapy for metastatic diseases. The primary endpoint of the study is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), time to cytotoxic chemotherapy, quality of life, and safety.
Global Initiatives and Partnerships
Henlius’ US partner, Sermonix Pharmaceuticals, Inc., has initiated the ELAINE-3 study abroad, with the first patient dosing occurring in January of this year. Clinical enrollment is actively underway in multiple regions, including the United States, Europe, and Canada. Henlius entered into a licensing deal with Sermonix in January, securing exclusive development, manufacturing, and commercialization rights in China for the drug, an oral selective estrogen receptor modulator (SERM). A supplementary deal in June expanded Henlius’s licensing territories to the entire Asia region.-Fineline Info & Tech
