- Results showed that younger age, non-visceral disease, prior tamoxifen and a longer total duration of AI use may be associated with higher baseline vaginal and/or vulvar symptomatology
- Findings were presented in a poster at The Menopause Society 2023 Annual Meeting
COLUMBUS, Ohio, Oct. 02, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, today shared the results of an exploratory analysis evaluating the effects of patient characteristics on baseline vaginal/vulvar symptoms during its Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study. The findings were shared Sept. 28 in a poster presentation at The Menopause Society (formerly North American Menopause Society, or NAMS) 2023 Annual Meeting.
Assessing a limited number (72) of patients with ER+/HER2- breast cancer, results showed that younger age, non-visceral disease, prior tamoxifen (a marker of pre-menopausal status at diagnosis), and a longer total duration of aromatase inhibitor (AI) use in the adjuvant or metastatic settings may be associated with higher baseline vaginal and/or vulvar symptomatology.
- Patients had more severe vaginal/vulvar symptoms if they were under age 40 (n=3) versus patients over 40, and if they did not have visceral disease compared with those who had visceral disease.
- Prior adjuvant tamoxifen was associated with more severe vaginal/vulvar symptoms, as was a longer total duration of AI use in both adjuvant and metastatic settings. Duration of prior AI in the adjuvant setting alone did not impact baseline vaginal or vulvar symptoms.
“As women are living longer with ER+ metastatic disease, it is extremely important to treat their symptoms to improve quality of life. Understanding how patient characteristics could impact sexual and genitourinary health will go a long way toward tailoring treatment options,” said Shari B. Goldfarb, M.D., assistant attending physician at Memorial Sloan Kettering Cancer Center, who co-authored the analysis. “These results, in a limited number of patients, demonstrate the need for greater investigation of this important concern for women confronted with breast cancer. I look forward to seeing the results of ELAINE-3, which will further evaluate the impact of sexual health patient-recorded outcomes on quality of life, as well as treatment effects on vaginal and sexual health.”
ELAINE-3 is a registrational Phase 3 study of 400 patients assessing the efficacy of lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor, abemaciclib, versus fulvestrant and abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. Enrollment is expected to begin during the second half of 2023.
ELAINE-1, which began enrollment in September 2019, 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. Top-line data were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022. A secondary exploratory analysis showed numeric improvements in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant (Goldfarb et al., 2023, ISSWSH).
“Sexual and overall urogenital health is a significant concern for women confronted with metastatic breast cancer, and Sermonix is focused on contributing to the understanding of these important tolerability and quality of life concerns,” said Dr. David Portman, Sermonix founder and chief executive officer. “Lasofoxifene, Sermonix’s lead investigational drug, has demonstrated potential benefit with respect to vaginal and sexual health, and we are excited to continue studying this element of disease management, which we know is so important to patients, during our ELAINE-3 trial.”
The poster was one of two Sermonix shared at The Menopause Society 2023 Annual Meeting. The other disclosed the results of EQUALS 2 (ESR1 QUAlity of Life Survey 2), a survey on the vaginal and sexual health of patients with ER+/HER2- metastatic breast cancer.
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 a CDK4/6 inhibitor 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 ER+ breast cancer.
Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com.
Monica Kozlowski, MSPH
Sermonix Product Manager