Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today broadly shared conclusions from a review of its three EQUALS (ESR1 QUAlity of Life Survey) surveys. Findings from the surveys revealed that women being treated for ER+/HER2- mBC experienced and were greatly concerned about vaginal/sexual side effects, which negatively impacted their intimate/sexual relationships, frequency of intercourse and self-esteem.

The review was initially shared yesterday in an oral and poster presentation – titled “EQUALS: Vaginal/Sexual Health (VSH) in Patients with ER+/HER2- Metastatic Breast Cancer (mBC)” – at the RISE UP for Breast Cancer conference.

With the understanding that vaginal/sexual health (VSH) issues are common but understudied in women with breast cancer being treated with endocrine therapy, Sermonix – guided by the esteemed EQUALS Steering Committee – conducted three EQUALS surveys from June 2022 to September 2023, drawing 887 respondents. The surveys explored the following experiences of women with ER+/HER- mBC: quality of life (QoL) and symptoms, biomarker knowledge, treatment side effects and patient-medical team communication.

“We were surprised to learn from the three EQUALS surveys that urogenital symptoms were a top concern and a major issue for patients being treated for metastatic breast cancer,” said Dr. Elizabeth Attias, Sermonix chief strategy and development officer, and an author of the EQUALS surveys. “This was underscored by the fact that most patients did not feel comfortable discussing this quality-of-life issue with their medical team. As mBC, gratefully, evolves from a lethal to a chronic condition, impacts to quality of life are magnified in importance. These results clearly point to the need for FDA-approved, well-tolerated breast cancer therapies that demonstrate a positive impact on vaginal/sexual health, and the importance of fostering an environment where patients feel comfortable asking for guidance.”

Noteworthy EQUALS results:

  • Vaginal symptoms were experienced by 61% of patients and associated with BC treatment for a mean of 4.8 years (EQUALS 2)
  • In EQUALS 2, 93% of patients expressed interest in an FDA-approved, well-tolerated breast cancer treatment that also improves vaginal/sexual health
  • Common side effects impacting QoL were vaginal atrophy/dryness in 36%-56% of EQUALS 1/EQUALS 3 patients, and sexual dysfunction in 45% of EQUALS 3 patients
  • More than half (60%) of patients thought their mBC or treatment negatively impacted their intimate/sexual relationships in EQUALS 1
  • In EQUALS 1/EQUALS 2, 31%-61% of patients were uncomfortable discussing intimacy and vaginal/sexual side effects with their medical team

"As we live longer with metastatic breast cancer, and as younger and younger women are diagnosed, urogenital and sexual side effects become more of a concern,” said Dr. Kelly Shanahan, a study co-author and member of the EQUALS Steering Committee, former ob/gyn and metastatic breast cancer patient who is a director at Metavivor Research and Support, Inc. “We have a currently incurable, life-shortening illness, and we shouldn't have to give up intimate physical relationships in the time we have.”

About SermonixSermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study 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. To learn more about the ELAINE studies, visit DiscoverElaine.com.

Sermonix Contact:Elizabeth Attias, Sc.D.Chief Strategy and Development OfficerEAttias@sermonixpharma.com(973) 723-7832