The ELAINE Study is an open-label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor 2-negative (HER2-) breast cancer with an acquired estrogen receptor 1 (ESR1) mutation and who have disease progression on an aromatase inhibitor (Al) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor*. The primary objective is to evaluate the progression-free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.
Sermonix Pharmaceuticals Inc. announced on July 8th, 2020 a collaboration with Eli Lilly and Company to study Sermonix’s lead investigational drug, lasofoxifene, in combination with Lilly’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib.
The open-label, multi-center Phase 2 clinical trial, which is projected to begin enrollment in the third quarter of 2020, 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. It marks Sermonix’s second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and will be known as ELAINE 2.
Sermonix Non-Confidential Company Presentation