Sermonix Pharmaceuticals Shares Results of EQUALS 2 Survey on Vaginal and Sexual Health in Patients with ER+/HER2- Metastatic Breast Cancer
02 10월 2023 - 10:00PM
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.
To learn more about Sermonix Pharmaceuticals and lasofoxifene,
visit https://sermonixpharma.com. To learn more about the ELAINE
studies, visit https://elainestudy.com.
About LasofoxifeneLasofoxifene 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 SermonixSermonix 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:Monica Kozlowski, MSPHSermonix
Product Managermkozlowski@sermonixpharma.com860-692-8548
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