• Most patients minimized or hid side effects from their health care providers for fear of negative perceptions, reduced treatment efficacy, or being taken off a drug or out of a clinical trial
  • Sexual dysfunction was the most commonly cited side effect with a negative impact on quality of life
  • Only half (49%) of surveyed patients felt extremely or very comfortable discussing side effects with providers

COLUMBUS, Ohio, Dec. 12, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC) harboring ESR1 mutations, today broadly shared the results of its third ESR1 and Quality of Life Survey (EQUALS 3).

“While Sermonix is highly focused on extending the lives of patients confronted with metastatic breast cancer, we are also cognizant that the quality of that extended life matters,” said Elizabeth Attias, Sc.D., Sermonix chief strategy and development officer. “Lasofoxifene, our lead investigational drug, has thus far demonstrated potential efficacy in combating metastatic breast cancer and potential benefit with respect to vaginal and sexual health. The EQUALS surveys have been vitally important in helping us more fully understand the complete patient experience, and we are extremely appreciative of those who have shared their journey.”

A 55-question survey of 213 people with ER+/HER2- mBC, EQUALS 3 was developed to help inform practicing oncologists about mBC patients’ understanding of ESR1 mutations and their quality of life (QoL). Noteworthy results included:

  • The most common side effects with a negative impact on QoL were sexual dysfunction (45%), joint pain (38%), vaginal atrophy/dryness (36%), fatigue (33%), bone pain (31%) and hair loss (26%).
  • Most patients (68%) considered QoL an important/very important consideration when making a treatment decision based on risks and benefits.
  • While half (49%) of patients felt extremely/very comfortable speaking to their providers about treatment side effects, 62% reported minimizing side effects in team discussions.
    • The top reasons for minimizing side effects were concern of being seen as a complainer (70%), receiving a dose reduction (66%) and being taken off a drug (65%).
    • About one-third of patients (36%) reported being only somewhat comfortable discussing side effects with providers.
  • The toxicity concerns most frequently reported as extremely/moderately concerning were respiratory symptoms (51%), blood clots in lungs (49%) or heart/brain (47%), cognitive dysfunction (47%), infections (46%), nausea/vomiting (44%), cardiac adverse effects (44%), diarrhea (42%), gait instability (41%), fatigue (39%), joint pain (39%), hair loss (33%) and sexual dysfunction (27%).
  • Patients reported that several important topics were missing from provider conversations: which rare but serious (44%) or common (32%) side effects to expect, and how to deal with potential side effects (39%).

“Though many patients expressed feeling relatively informed, EQUALS 3 underscores the importance of patient dialogue about which side effects impact individuals the most, not just regarding treatment toxicities but also quality of life impacts such as vaginal and sexual health and functioning,” said Dr. Kelly Shanahan, an EQUALS 3 co-author, former clinician and metastatic breast cancer patient who is a director at Metavivor Research and Support, Inc. “There is more work to be done in limiting the side effects that greatly impact metastatic breast cancer patients’ lives, and in improving patient-provider communication around these all-important quality of life concerns.”

The results were initially presented last week in two poster presentations at the 2023 San Antonio Breast Cancer Symposium. One poster addressed minimizing treatment toxicity and side effects impacting QoL for ER+/HER2- mBC patients, and the other discussed patient-provider communication challenges with respect to expectations and side effects of mBC treatments.

Sermonix is currently enrolling patients in its Phase 3 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-3) clinical registrational study. ELAINE-3 will compare targeted lasofoxifene in combination with Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com. For more information about the ELAINE studies, visit https://elainestudy.com/.

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 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.

About Sermonix
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.

Sermonix Contact:
Elizabeth Attias, Sc.D.
Chief Strategy and Development Officer
(973) 723-7832