Menarini Group and Radius Health present a subgroup analysis from the elacestrant pivotal phase 3 EMERALD clinical trial at the ASCO Annual Meeting
PR96360
Menarini Group and Radius Health, Inc. present a subgroup analysis from the elacestrant pivotal phase 3 EMERALD clinical trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting
FLORENCE, Italy and BOSTON, June 6, 2022 /PRNewswire-AsiaNet/--
Subgroup analysis of patients with no prior chemotherapy in EMERALD: A phase 3
trial evaluating elacestrant, an investigational oral selective estrogen
receptor degrader (SERD), vs. investigator’s choice of endocrine monotherapy
for ER+/HER2- advanced/metastatic breast cancer (mBC)
The Menarini Group (“Menarini”) and Radius Health, Inc. (“Radius”) (NASDAQ:
RDUS) (collectively, the “Companies”) today announced the presentation at the
2022 American Society of Clinical Oncology (ASCO) Annual Meeting of data from
the EMERALD phase 3 clinical trial (NCT03778931). In a non-pre-specified
subgroup analysis of patients with ER+/HER2- metastatic breast cancer
(mBC) without prior chemotherapy in the metastatic setting, elacestrant
significantly prolonged progression-free survival (PFS) compared to standard of
care (SOC) endocrine therapy.
• EMERALD study met both of its pre-specified primary end points of
progression-free survival (PFS) in the overall population and in patients with
ESR1 mutation (mESR1)1
• 77.8% (n=371) out of the 477 patients enrolled in the trial had not received
prior chemotherapy in the metastatic setting for ER+/HER2- mBC. Among
these patients, elacestrant showed the following results compared to SOC:
o 31% reduction in the risk of progression or death in all patients (HR=0.681
[95% CI: 0.520 – 0.891]; P=0.00388) and prolonged median PFS (3.68 vs 1.97
months).
o 46% reduction in the risk of progression or death in patients with mESR1
(HR=0.535 [95% CI: 0.356 – 0.799]; P=0.00235) and prolonged median PFS (5.32 vs
1.91 months).
• At 6 months, PFS rate with elacestrant was 38.18% vs. 23.47% with SOC in the
overall population, and 43.79% vs. 23.83% in the ESR1 mutation population.
• PFS rate at 12 months with elacestrant was 27.12% vs. 12.19% with SOC in the
overall population, and 31.48% vs. 12.36% in the ESR1 mutation population
• In exploratory subgroup analyses, elacestrant significantly reduced the risk
of progression or death and prolonged median PFS vs fulvestrant in all patients
without prior chemotherapy (HR=0.636 [95% CI: 0.465-0.868]; median PFS 3.68 vs
1.97 months; P=0.0032), and in patients with mESR1 without prior chemotherapy
(HR=0.487 (95% CI: 0.310-0.761; median PFS 5.32 vs 1.91 months; P=0.0015).
• Elacestrant had a manageable safety profile in patients without prior
chemotherapy consistent with the overall population1
Dr. Virginia Kaklamani, breast medical oncologist and professor of medicine, UT
Health San Antonio, MD Anderson Cancer Center, commented, “Elacestrant is a
potential exciting new endocrine therapy after progression on a CDK4/6
inhibitor in women with ER+ metastatic breast cancer. The EMERALD trial showed
that elacestrant is active even in patients whose tumors harbor an ESR1
mutation. This subset analysis additionally showed that patients who have not
previously been treated with chemotherapy in the metastatic setting had longer
progression free survival up to 5.32 months.”
Menarini plans to pursue combination studies and study the potential of
elacestrant to be effective in addressing the highest unmet needs for
ER+/HER2-patients.
Poster Presentation: 477
Abstract Title: Subgroup analysis of patients with no prior chemotherapy in
EMERALD: A phase 3 trial evaluating elacestrant, an oral selective estrogen
receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for
ER+/HER2- advanced/metastatic breast cancer (mBC)
Abstract Number: 1100
Poster Session: Breast Cancer – Metastatic
About Elacestrant (RAD1901) and EMERALD Phase 3 Study
Elacestrant is an investigational selective estrogen receptor degrader (SERD),
out-licensed to Menarini Group, which is being evaluated for potential use as a
once daily oral treatment in patients with ER+/ HER2- advanced breast cancer.
In 2018, elacestrant received fast track designation from the FDA. Preclinical
studies completed prior to EMERALD indicate that the compound has the potential
for use as a single agent or in combination with other therapies for the
treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open
label, active-controlled study evaluating elacestrant as second- or third-line
monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study
enrolled 477 patients who have received prior treatment with one or two lines
of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were
randomized to receive either elacestrant or the investigator’s choice of an
approved hormonal agent. The primary endpoint of the study was progression-free
survival (PFS) in the overall patient population and in patients with estrogen
receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of
overall survival (OS), objective response rate (ORR), and duration of response
(DOR).
References
1. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective
estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen
Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced
Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin
Oncol. 2022 May 18:JCO2200338. doi.org: 10.1200/JCO.22.00338. Epub ahead of
print[https://ascopubs.org/doi/full/10.1200/JCO.22.00338].
About Menarini
The Menarini Group is a leading international pharmaceutical and diagnostics
company, with a turnover of over $4 billion and over 17,000 employees. Menarini
is focused on therapeutic areas with high unmet needs with products for
cardiology, oncology, pneumology, gastroenterology, infectious diseases,
diabetology, inflammation, and analgesia. With 18 production sites and 9
Research and Development centers, Menarini’s products are available in 140
countries worldwide. For further information, please visit www.menarini.com.
About Radius
Radius is a global biopharmaceutical company focused on addressing unmet
medical needs in the areas of bone health, orphan diseases, and oncology.
Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the
U.S. Food and Drug Administration for the treatment of postmenopausal women
with osteoporosis at high risk for fracture. The Radius clinical pipeline
includes investigational abaloparatide injection for potential use in the
treatment of men with osteoporosis; an investigational abaloparatide
transdermal system for potential use in the treatment of postmenopausal women
with osteoporosis; the investigational drug, elacestrant (RAD1901), for
potential use in the treatment of hormone-receptor positive breast cancer
out-licensed to Menarini Group; and the investigational drug RAD011, a
synthetic cannabidiol oral solution with potential utilization in multiple
neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas,
initially targeting Prader-Willi syndrome, Angelman syndrome, and infantile
spasms.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical fact should
be considered forward-looking statements, including without limitation
statements regarding the expected regulatory submissions in the United States
and European Union; and ongoing clinical development activities with respect to
elacestrant.
These forward-looking statements are based on management's current
expectations. These statements are neither promises nor guarantees, but involve
known and unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not limited to, the
following: the adverse impact the ongoing COVID-19 pandemic is having and is
expected to continue to have on our business, financial condition and results
of operations, including our commercial operations and sales, clinical trials,
preclinical studies, and employees; quarterly fluctuation in our financial
results; our dependence on the success of TYMLOS, and our inability to ensure
that TYMLOS will obtain regulatory approval outside the U.S. or be successfully
commercialized in any market in which it is approved, including as a result of
risk related to coverage, pricing and reimbursement; risks related to
competitive products; risks related to our ability to successfully enter into
collaboration, partnership, license or similar agreements; risks related to
clinical trials, including our reliance on third parties to conduct key
portions of our clinical trials and uncertainty that the results of those
trials will support our product candidate claims; the risk that adverse side
effects will be identified during the development of our product candidates or
during commercialization, if approved; risks related to manufacturing, supply
and distribution; and the risk of litigation or other challenges regarding our
intellectual property rights. These and other important risks and uncertainties
discussed in our filings with the Securities and Exchange Commission, or SEC,
including under the caption “Risk Factors” in our Annual Report on Form 10-K
for the year ending December 31, 2021 and subsequent filings with the SEC,
could cause actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this press
release. While we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent to the date
of this press release.
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Source: Menarini Industrie Farmaceutiche Riunite
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