An ESR1 evaluation
COLUMBUS, Ohio—A new collaboration is underway between Sermonix Pharmaceuticals Inc. and Eli Lilly and Co. to evaluate a combination regimen of Sermonix’s lead candidate lasofoxifene and Lilly’s abemaciclib, an FDA-approved CDK 4 and 6 inhibitor. The companies will conduct ELAINE2, an open-label, multi-center Phase 2 clinical trial to evaluate the safety of the combination in pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2-negative (HER2-) breast cancer and an ESR1 mutation.
“Endocrine therapy is the backbone of combination therapies in ER+/HER2- breast cancer, and as a well-characterized compound, lasofoxifene may offer patients a potentially well-tolerated oral option alone and in combination in an area of significant unmet need,” said Sermonix Board Chairman Dr. Anthony Wild. “We look forward to embarking on ELAINE 2 and executing on this important trial.”