Menarini Group and Radius Health announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology
PR96106
Menarini Group and Radius Health, Inc. announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology
FLORENCE, Italy and BOSTON, May 20, 2022 /PRNewswire=KYODO JBN/ --
-Emerald study met both its primary end points of Progression-free survival
(PFS) in overall population and in ESR1 mutated patients
-PFS rate at 12 months with elacestrant was 22.32% vs. 9.42% with SOC in the
overall population, and 26.76% vs. 8.19% in the ESR1 mutation population
-Data demonstrated elacestrant significantly reduced the risk of disease
progression or death by 30% in all patients and by 45% in patients with ESR1
mutation
-Compared with fulvestrant, elacestrant demonstrated statistically significant
PFS and reduced the risk of progression or death by 32% in the overall
population and 50% in the ESR1 mutation population
The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ:
RDUS) (collectively, the "Companies") today announced that data from the
pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as
a monotherapy vs. standard of care (SOC; fulvestrant or aromatase inhibitor,
AI) for the treatment of ER+/HER2- advanced or metastatic breast cancer were
published in the Journal of Clinical Oncology.1 Elacestrant is the first oral
selective estrogen receptor degrader (SERD) demonstrating a significant
improvement in PFS vs. SOC with manageable safety in a phase 3 trial for
patients with ER-positive/HER2-negative advanced breast cancer.
Dr. Aditya Bardia, breast medical oncologist and director of Breast Cancer
Research at Mass General Cancer Center, Harvard Medical School and principal
investigator of the EMERALD clinical trial, commented, "There is an urgent
unmet need for oral SERDs that are safe and effective against ER-positive
metastatic breast cancer after progression on earlier lines of therapy,
including CDK4/6 inhibitors. EMERALD is the first study to demonstrate a
significant improvement in clinical outcomes with elacestrant, an oral SERD
monotherapy, versus standard of care in a randomized, global phase III study
for patients with ER-positive/HER2-negative advanced breast cancer. Further
research is needed to develop combination therapies as well as evaluate novel
endocrine therapies for patients with early breast cancer."
As reported in the Journal of Clinical Oncology:
Patients had disease progression during or within 1 month following 1 or 2
lines of endocrine therapy and a cyclin-dependent kinase (CDK) 4/6 inhibitor.
Patients could also have received 1 line of chemotherapy.
-43% received 2 prior endocrine therapies for advanced breast cancer
-22% received chemotherapy for advanced breast cancer
-48% had detectable ESR1 mutation
Patients were randomized 1:1 to elacestrant (400 mg orally daily) or SOC
choice of fulvestrant or AI; the protocol recommended that patients previously
treated with fulvestrant receive AI and patients previously treated with AI
receive fulvestrant.
Among the 477 patients enrolled in the trial, 239 received elacestrant.
Of the 165 patients who received fulvestrant all were pretreated with AI
during the treatment for metastatic disease except n=6 who received
fulvestrant. Of the 73 who received AI all were pretreated with fulvestrant
except n=4.
Primary endpoints were PFS by blinded independent central review (IRC) in
all patients and patients with detectable ESR1 mutations.
Elacestrant significantly reduced the risk of disease progression or death
by 30% in all patients and by 45% in patients with ESR1 mutation.
-PFS was prolonged in all patients (HR=0.70; 95% CI, 0.55–0.88; P=0.0018)
-PFS was prolonged in patients with ESR1 mutation (HR=0.55; 95% CI,
0.39–0.77; P=0.0005)
PFS rate at 12 months with elacestrant was 22.3% vs. 9.4% with SOC in the
overall population, and 26.8% vs. 8.2% in the ESR1 mutation population
The most common treatment emergent adverse events (AEs) in patients
receiving elacestrant were mild or moderate gastrointestinal events.
Nausea was the most common AE.
-Any severity: 35% of patients receiving elacestrant and 16% fulvestrant,
25% receiving AI
-Severe (grade 3 or 4): 2.5% of patients receiving elacestrant and 0.9%
receiving SOC
Treatment-related grade 3/4 AEs occurred in 7.2% of patients receiving
elacestrant and 3.1% receiving SOC. Treatment was discontinued due to a
treatment-related AEs in 3.4% receiving elacestrant and 0.9% receiving SOC.
A subgroup analysis of patients with no prior chemotherapy in EMERALD will
be presented at ASCO 2022 (Abstract: 1100)
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.
About Elacestrant (RAD1901) and EMERALD Phase 3 Study
Elacestrant is a 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. [
https://ascopubs.org/doi/full/10.1200/JCO.22.00338 ] J Clin Oncol. 2022 May
18:JCO2200338. doi.org: 10.1200/JCO.22.00338. Epub ahead of print.
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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