Exploratory Analysis Identifies Factors Influencing Vaginal/Vulvar Symptoms in Metastatic ESR1 Mutations Study
Sermonix Pharmaceuticals Inc., a biopharmaceutical company focused on developing innovative therapies for metastatic breast cancers, has revealed the findings of an exploratory analysis that examined the impact of patient characteristics on vaginal and vulvar symptoms. The analysis was conducted as part of the Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study and the results were presented at The Menopause Society’s 2023 Annual Meeting.
The analysis, which assessed a group of 72 patients with ER+/HER2- breast cancer, highlighted that certain factors may be associated with higher baseline vaginal and/or vulvar symptomatology. These factors include younger age, non-visceral disease, prior tamoxifen use (indicating pre-menopausal status at diagnosis), and a longer duration of aromatase inhibitor (AI) use in either the adjuvant or metastatic settings.
Dr. Shari B. Goldfarb, co-author of the analysis and assistant attending physician at Memorial Sloan Kettering Cancer Center, emphasized the importance of treating symptoms to improve the quality of life for women living longer with ER+ metastatic disease. She highlighted the need for further investigation into how patient characteristics impact sexual and genitourinary health, while also looking forward to the results of ELAINE-3, which will assess the impact of sexual health on quality of life and treatment effects on vaginal and sexual health.
ELAINE-3, a Phase 3 study involving 400 patients, is set to begin enrollment in the latter half of 2023. It aims to evaluate the efficacy of lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor, abemaciclib, compared to fulvestrant and abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer harboring an ESR1 mutation.
Dr. David Portman, founder and CEO of Sermonix Pharmaceuticals, expressed the company’s commitment to addressing the concerns surrounding sexual and overall urogenital health in women with metastatic breast cancer. He highlighted the potential benefit of lasofoxifene in improving vaginal and sexual health, and the company’s excitement to continue studying this aspect of disease management during the ELAINE-3 trial.
In addition to the presented analysis, Sermonix shared the results of the EQUALS 2 survey, which focused on the vaginal and sexual health of patients with metastatic breast cancer.
Lasofoxifene, Sermonix’s lead investigational drug, is a targeted oral endocrine therapy that specifically engages with estrogen receptor alpha (ESR1) in breast tissue, particularly in the presence of ESR1 mutations. Previous studies have demonstrated its anti-tumor activity and unique tissue selectivity, with positive effects seen on the vagina and bone. The investigational drug could offer promise for patients who have acquired endocrine resistance due to ESR1 mutations, which is a common occurrence in the metastatic setting.
Sermonix Pharmaceuticals is dedicated to developing female-specific oncology products, and its management team has extensive experience in all stages of drug development, regulatory processes, and commercialization.
For more information about Sermonix Pharmaceuticals and lasofoxifene, please visit their official website. Further details about the ELAINE studies can be found on the ELAINE study website.
About Sermonix Pharmaceuticals: Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on developing female-specific oncology products. Led by Dr. David Portman, the company’s management team has significant expertise in drug development, regulatory processes, and commercialization. Sermonix is currently conducting two Phase 2 clinical studies on lasofoxifene, its lead investigational drug.
