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Find Clinical Drug Pipeline Developments & Deals by Sermonix Pharmaceuticals
HLX78 (lasofoxifene) receives approval to join the ongoing global registrational ELAINE-3 trial with responsibility in China for the treatment of ER+/HER2 ESR1-mutated Breast Neoplasms.
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.
Objective response rate was 13.2% for lasofoxifene vs. 2.9% for fulvestrant, P=0.12, with 1 confirmed complete response (CR) (72-week duration) and 4 confirmed partial responses (PR) in the lasofoxifene arm vs. 1 PR in the fulvestrant arm.
The project will investigate the effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations studies within the breast cancer arena.
The open-label, multi-center study will evaluate the safety of lasofoxifene in combination with abemaciclib for the treatment of pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation.