- Results from the Phase III OASIS 3 study further support
efficacy data and sustained safety data of elinzanetant over 52
weeks, adding to the positive results of the OASIS 1 and 2
studies
- The long-term safety was consistent with previous findings,
further confirming the favorable safety profile; no incidences of
endometrial hyperplasia or endometrial malignant neoplasms; no
signal of hepatotoxicity was observed
- These late-breaking data will be presented for the first time
at the 2024 annual meeting of The Menopause Society (TMS)
- Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3)
receptor antagonist, in late-stage clinical development for the
non-hormonal treatment of moderate to severe VMS associated with
menopause, administered orally once daily
Bayer will present detailed results from the Phase III study
OASIS 3, providing supporting efficacy data and sustained safety
data over 52 weeks for the investigational compound elinzanetant,
adding to the positive results of the OASIS 1 and 2 studies. These
data will be presented at the 2024 annual meeting of The Menopause
Society (TMS) taking place from September 10-14, in Chicago, IL,
USA.
OASIS 3 is a Phase III efficacy and long-term safety study of
elinzanetant for the treatment of vasomotor symptoms (VMS, also
known as hot flashes) associated with menopause.
The data to be presented shows that elinzanetant successfully
met the primary endpoint demonstrating a statistically significant
reduction in the frequency of moderate to severe vasomotor symptoms
from baseline to week 12 compared to placebo. Improvements in the
elinzanetant arm were also seen in key secondary endpoints with a
mean change from baseline in sleep disturbances and menopause
related quality of life as shown by the total score over time.
There was no minimum threshold of moderate to severe VMS for
inclusion in the study, and at baseline women had a mean of 6.7 VMS
(square difference, SD 7.2) in the elinzanetant group and 6.8 in
the placebo group (SD 6.2). After 12 weeks of treatment, the number
of VMS was reduced to 1.6 (SD 2.5) in the elinzanetant group and
3.4 (SD 4.2) in the placebo group. The VMS reductions were
maintained throughout the study duration. In addition, improvements
were seen in measures of sleep disturbances and menopause-related
quality of life with elinzanetant use over 52 weeks, based on
descriptive analyses.
“To see the tolerability of elinzanetant in OASIS 3 remain
consistent with earlier studies is very promising,” said James A.
Simon, M.D., clinical professor of obstetrics and gynecology at The
George Washington University School of Medicine, Founder of
IntimMedicine Specialists. “With a longer study duration and in a
population with a VMS profile potentially more representative of
that seen in clinical practice suggests, if approved, elinzanetant
may be another option for women suffering from moderate to severe
VMS.”
The safety profile of elinzanetant over 52 weeks was favorable
and consistent with findings from the 26-week OASIS 1 and OASIS 2
studies, which were recently published in the Journal of the
American Medical Association (JAMA).1 In OASIS 3, headache and
COVID-19 were the most frequently reported treatment emergent
adverse events (TEAEs) within the elinzanetant group. No incidences
of endometrial hyperplasia, endometrial malignant neoplasms, and no
liver toxicity signal were observed with elinzanetant.
“The detailed results of OASIS 3 are complementing the positive
results of OASIS 1 and 2, addressing the question on its long-term
profile and indicating the potential of elinzanetant to treat
moderate to severe VMS associated with menopause,” said Dr.
Christian Rommel, Global Head of Research and Development at Bayer
AG’s Pharmaceuticals Division. “We look forward to continuing our
discussions with health authorities around the world regarding
marketing authorizations for this compound.”
Elinzanetant is the first dual neurokinin-1 and -3 (NK-1 and 3)
receptor antagonist, in late-stage clinical development for the
non-hormonal treatment of moderate to severe VMS associated with
menopause, administered orally once daily.
OASIS 3 (NCT05030584) is the third Phase III study in the OASIS
clinical development program with positive results. Results from
the first two Phase III studies OASIS 1 and 2 (NCT05042362 and
NCT05099159) were recently published in The Journal of the American
Medical Association (JAMA). Based on positive results from OASIS 1,
2 and 3, Bayer has submitted a New Drug Application to the U.S. FDA
for elinzanetant for the treatment of moderate to severe VMS
associated with menopause. Bayer is continuing to submit
applications for marketing authorizations of elinzanetant to
further health authorities as well.
About the OASIS 1, 2 and 3 studies
OASIS 1 and 2 (NCT05042362 and NCT05099159) are double-blind,
randomized, placebo-controlled multicenter studies investigating
the efficacy and safety of elinzanetant administered orally once
daily in women with moderate to severe VMS associated with
menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400
postmenopausal women between 40 and 65 years across 184 sites in 15
countries. Patients in the elinzanetant arm received a 120 mg dose
of elinzanetant once daily for 26 weeks and patients in the control
arm received a matching placebo once daily for 12 weeks, followed
by elinzanetant 120 mg dose for 14 weeks. OASIS 3 (NCT05030584) is
a double-blind, randomized, placebo-controlled multicenter study to
investigate the efficacy and safety of elinzanetant for the
treatment of vasomotor symptoms over 52 weeks in postmenopausal
women. OASIS 3 randomized 628 postmenopausal women between 40 and
65 years across 83 sites in 9 countries.
About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant,
OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3
and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and
safety of elinzanetant 120 mg in women with moderate to severe VMS
associated with menopause. The OASIS 4 study is an expansion of the
clinical Phase III program and investigates the efficacy and safety
of elinzanetant in women with moderate to severe VMS caused by
endocrine therapy for treatment or prevention of breast cancer.
The design and dosing of the Phase III clinical development
program is based on the positive data from two Phase II studies
(RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study
investigating the safety, pharmacokinetics and preliminary efficacy
of elinzanetant. SWITCH-1 was a Phase IIb study investigating the
efficacy and safety of four different doses of elinzanetant
compared to placebo in women with VMS.
In addition to the OASIS program, Bayer is conducting NIRVANA
(NCT06112756), an exploratory Phase II randomized, parallel-group
treatment, double-blind study. The primary objective is to explore
the efficacy of elinzanetant on sleep disturbances associated with
menopause (SDM) as determined by polysomnography (PSG). PSG is a
validated method to study sleep and underlying causes of sleep
disturbances. Additional objectives include exploring the efficacy
of elinzanetant on SDM as determined by patient-reported outcomes
and further evaluating the safety of elinzanetant.
About Elinzanetant
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3)
receptor antagonist, in late-stage clinical development for the
non-hormonal treatment of moderate to severe VMS associated with
menopause, administered orally once daily. Elinzanetant may address
moderate to severe VMS by modulating a group of estrogen sensitive
neurons in the hypothalamus region of the brain (the KNDy neurons)
which, with the decrease of estrogen, become hypertrophic and lead
to a hyperactivation of the thermoregulatory pathway, consequently
disrupting body heat control mechanisms resulting in VMS. Based on
key secondary endpoints of Oasis 1 and 2, Elinzanetant may also
decrease sleep disturbances associated with menopause.
About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result
from hyperactivation of the thermoregulatory pathway mediated by
hypertrophy of the KNDy neurons. This is due to a decrease of
estrogen, which can result from the progressive reduction of
ovarian function due to natural menopause or medical intervention
by bilateral oophorectomy or endocrine therapy.
VMS are reported by up to 80% of women at some point during the
menopausal transition and are one of the leading causes for seeking
medical attention during this phase of a woman’s life. Over
one-third of menopausal women report severe symptoms, which can
last 10 years or more after the last menstrual period, with
relevant impact on quality of life.
VMS may also be caused by endocrine therapy, for the treatment
or prevention of breast cancer, impacting quality of life and
treatment adherence. For these women, there are currently no
approved treatment options.
About Menopause
By 2030, the global population of women experiencing menopause
is projected to increase to 1.2 billion, with 47 million women
entering this phase each year. Menopause is a transitional phase in
women’s lives, related to the progressive decline of ovarian
function. It usually occurs in women during their 40s or early 50s.
It can also be the result of surgical or medical treatment such as
breast cancer treatment. The hormonal decline can lead to various
symptoms which can substantially affect a woman’s health, quality
of life, healthcare utilization and work productivity. The most
frequently reported and disruptive symptoms during the menopausal
transition are VMS, sleep disturbances and mood changes. Addressing
these symptoms is key to maintaining functional ability and quality
of life in menopause which is highly relevant from both a
healthcare and socio-economic perspective.
About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s
healthcare Bayer has a long-standing commitment to delivering
science for a better life by advancing a portfolio of innovative
treatments. Bayer offers a wide range of effective short- and
long-acting birth control methods as well as therapies for
menopause management and gynecological diseases. Bayer is also
focusing on innovative options to address the unmet medical needs
of women worldwide and to broadening treatment choices such as in
menopause. Additionally, Bayer intends to provide 100 million women
per year in low-and-middle income countries by 2030 with access to
family planning by funding multi-stakeholder aid programs for
capacity building and by ensuring the supply of affordable modern
contraceptives. This is part of the comprehensive sustainability
measures and commitments from 2020 onwards and in line with the
Sustainable Development Goals of the United Nations.
About Bayer
Bayer is a global enterprise with core competencies in the life
science fields of health care and nutrition. In line with its
mission, “Health for all, Hunger for none,” the company’s products
and services are designed to help people and the planet thrive by
supporting efforts to master the major challenges presented by a
growing and aging global population. Bayer is committed to driving
sustainable development and generating a positive impact with its
businesses. At the same time, the Group aims to increase its
earning power and create value through innovation and growth. The
Bayer brand stands for trust, reliability and quality throughout
the world. In fiscal 2023, the Group employed around 100,000 people
and had sales of 47.6 billion euros. R&D expenses before
special items amounted to 5.8 billion euros. For more information,
go to www.bayer.com.
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kw (2024-0121E)
Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer management. Various
known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results,
financial situation, development or performance of the company and
the estimates given here. These factors include those discussed in
Bayer’s public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
References
1 https://jamanetwork.com/journals/jama/fullarticle/2822766
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