- More than 60% of survey respondents experienced vaginal symptoms and felt their sexual health was negatively impacted by prior endocrine therapy
- About half never or almost never felt sexual desire or interest in the previous month, particularly those whose sexual health was negatively impacted by prior endocrine therapy (61%)
- 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 EQUALS 2 (ESR1 QUAlity of Life Survey 2), a survey on the vaginal and sexual health of patients with ER+/HER2- metastatic breast cancer. The findings were shared Sept. 28 in a poster presentation at The Menopause Society (formerly North American Menopause Society, or NAMS) 2023 Annual Meeting.
Among the findings of EQUALS 2, a 50-question online survey completed by 200 patients, were:
- More than 60% experienced vaginal symptoms and felt their sexual health was negatively impacted by prior endocrine therapy.
- About half (54%) of respondents never or almost never felt sexual desire/interest in the previous month, particularly those whose sexual health was negatively impacted by prior endocrine therapy; 56% felt bothered by low sexual desire.
- About a third of respondents felt poorly informed (38%) or uncomfortable discussing these side effects (31%) with their medical team.
- The majority (93%) of respondents showed interest in trying a treatment if it was effective in treating breast cancer, FDA approved, well tolerated and could potentially improve vaginal/sexual health.
- The vaginal/sexual side effects of breast cancer treatment were a concern for most patients (80%), negatively impacting the frequency of sexual intercourse (61%) and their self-esteem (64%), and making 51% feel isolated. Most (78%) felt that breast cancer negatively impacted their body image.
“The EQUALS 2 results highlight the unmet vaginal and sexual health needs of women undergoing treatment for metastatic breast cancer, and the importance of improving communication on this topic between patients and their oncologists,” said Dr. Kelly Shanahan, an EQUALS 2 co-author, former clinician and metastatic breast cancer patient who is a director at Metavivor Research and Support, Inc. “Quality of life should not be an overlooked element of the cancer management equation, and treatments that promote sexual health should be a focus of everyone working to confront this disease.”
Sermonix in March initiated feasibility for ELAINE-3, a registrational Phase 3 study of 400 patients assessing the efficacy of its lead investigational drug, 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.
“The results of our EQUALS 2 survey demonstrate that sexual and overall urogenital health is a significant concern for women being treated for metastatic breast cancer,” said Elizabeth Attias, ScD, Sermonix chief strategy and development officer. “Sermonix looks forward to further investigating these understudied yet important elements of tolerability and quality of life during our Phase 3 ELAINE-3 study of lasofoxifene, which has demonstrated potential benefit with respect to vaginal and sexual health.”
The poster was one of two Sermonix shared at The Menopause Society 2023 Annual Meeting. The other was an exploratory analysis of baseline patient genitourinary symptoms during its Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study.
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