On February 8, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, reported that it had an abstract accepted as a Discussed E-poster Presentation at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2023 (Press release, Sermonix Pharmaceuticals, FEB 8, 2023, View Source [SID1234626964]). The conference takes place March 3-5 in St. Louis.
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The poster, "Vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ESR1-mutated, ER+/HER2- metastatic breast cancer patients," will be presented Saturday, March 4, at the Marriott St. Louis Grand. Presentation details are as follows:
Session: E-poster Session 10 – Cancer & Chronic Medical Illness
Date/time: Saturday, March 4, 2023; 2:50 p.m. – 3:20 p.m. CST
Presenter: Shari B. Goldfarb, M.D., Assistant Attending Physician, Memorial Sloan Kettering Cancer Center
The poster shares results from the open-label randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019. Top-line data were revealed in September at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. ELAINE 1 assessed the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.
The objective of the abstract to be shared at the ISSWSH Annual Meeting was to evaluate an exploratory endpoint of patient-reported vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ELAINE 1 participants.
About Lasofoxifene
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced HR+ breast cancer.