Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021
PR93568
FLORENCE, Italy and BOSTON, Dec. 8, 2021 /PRNewswire=KYODO JBN/ --
- Trial met both primary endpoints demonstrating statistically significant and
clinically meaningful extension of progression free survival (PFS) as
monotherapy vs. standard of care (SoC) endocrine therapy in overall population
and estrogen receptor mutation (mESR1) population
- In the overall population, elacestrant reduced risk of progression or death
by 30% vs. SoC
- In the mESR1 population, elacestrant reduced risk of progression or death by
45% vs. SoC
- PFS rate at 12 months with elacestrant was 22.32% versus 9.42% with SoC in
the overall population, and 26.76% versus 8.19% in the mESR1 population
- Compared to fulvestrant, elacestrant demonstrated statistically significant
PFS and reduced the risk of progression or death by 32% in the overall
population and 50% in the mESR1 population
- With these results, elacestrant became the first oral SERD to demonstrate
higher efficacy than fulvestrant in a pivotal trial
- Elacestrant was well tolerated and can become standard of care in this
patient population
The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ:
RDUS) (collectively, the "Companies") provided details on the elacestrant data
from the EMERALD trial following the positive results presented today at the
San Antonio Breast Cancer Symposium (SABCS). The data was presented as a "Late
Breaker" and shared in an oral presentation by Dr. Aditya Bardia, MD.
The EMERALD trial (NCT03778931), a multicenter, international, randomized,
open-label, controlled phase 3 trial evaluated elacestrant as a monotherapy
versus SoC for the treatment of ER+/HER2- advanced or mBC. The trial enrolled
patients who had received 1 or 2 prior lines of endocrine therapy (ET). Prior
progression on an ET plus CDK4/6 inhibitors was mandated for all patients. Up
to 1 line of chemotherapy was allowed.
EMERALD met its two primary endpoints: progression-free survival in the overall
population and PFS in patients with tumors harboring Estrogen Receptor 1
mutations.
Dr. Aditya Bardia, MD, breast medical oncologist at Mass General Cancer Center,
Harvard Medical School and principal investigator of EMERALD, commented,
"Patients with pre-treated ER+/HER2- advanced or metastatic breast cancer
currently have limited treatment options due to the development of endocrine
therapy resistance from earlier treatment lines." Dr. Bardia continued,
"Elacestrant – as the first oral SERD – has the potential to become the new
standard of care given its performance vs. intramuscular fulvestrant and SoC in
the overall population and in the ESR1 patient subgroup. As an oral
monotherapy, elacestrant will offer patients, their families, and healthcare
providers an efficacious and safe treatment option going forward."
Elcin Barker Ergun, Chief Executive Officer of the Menarini Group, commented,
"We are extremely pleased with the results from the EMERALD study. The data
appears to demonstrate that elacestrant can create a well tolerated,
efficacious oral option vs. fulvestrant and SoC in 2/3 line for patients
suffering from advanced or metastatic breast cancer, including those patients
with a tumor harboring ESR1 mutations, one of the most difficult to treat
subgroups in such cancers. We plan to proceed with regulatory submissions in
the United States and European Union in 2022 given the positive safety and
efficacy results and thank all patients, their families and healthcare
professionals for participating in this important clinical trial."
Menarini plans to pursue combination studies and initiate activity in new lines
of therapy such as the adjuvant setting, enabling elacestrant to be utilized in
fully addressing the highest unmet needs for ER+/HER2-patients. In 2018,
elacestrant received fast track designation from the FDA.
Trial Results:
All patients were mandated to be treated with CDK 4/6 inhibitors. Moreover,
patient population characteristics showed that 69.4% of patients had visceral
metastasis and 22.2% received chemotherapy. EMERALD met both primary endpoints,
which measured PFS of elacestrant as a monotherapy vs. SoC in the overall and
mESR1 populations:
- Overall Population
- Reduced risk of progression or death vs. SoC by 30% (HR=0.697 [95% CI:
0.552, 0.880]; P=0.0018)
- Extended median PFS by 2.79 months versus SoC of 1.91
- At 12 months, probability of PFS was 22.3% (95% CI: 15.2%, 29.4%) with
elacestrant vs. 9.4% (95% CI: 4.0%, 14.8%) with SoC
- Compared to fulvestrant, elacestrant reduced risk of progression or death by
32% (HR=0.684 [95% CI: 0.521, 0.897]; P=0.0049)
- ESR1 Mutation Population
- Reduced risk of progression or death versus SoC by 45% (HR=0.546 [95% CI:
0.387, 0.768]; P=0.0005)
- Extended median PFS by 3.78 months versus SoC of 1.87
- At 12 months, probability of PFS was 26.8% (95% CI: 16.2%, 37.4%) with
elacestrant vs. 8.2% (95% CI: 1.3%, 15.1%) with SoC
- Compared to fulvestrant, elacestrant reduced the risk of progression or
death by 50% (HR=0.504 [95% CI: 0.341, 0.741]; P=0.0005)
- In both patient populations, results in key pre-specified subgroups,
including visceral metastases, number of prior lines, and geographical region,
were consistent with the overall outcome
A key secondary endpoint for the EMERALD trial is Overall Survival (OS). A pre
specified interim analysis indicates a trend favoring elacestrant over SoC in
both patient groups. Final analysis is expected to occur in late 2022 or early
2023.
Safety Results:
Elacestrant was well tolerated with an encouraging safety profile consistent
with other ETs:
- TEAEs leading to discontinuation: infrequent in both elacestrant and SoC arms
(6.3% and 4.4%)
- Grade 3 and higher TRAE were 7.2% for elacestrant and 3.1% for SoC
- Grade 3 and higher adverse events for elacestrant: nausea, vomiting and
diarrhea were 2.5%, 0.8% and 0%, respectively
A detailed evaluation of data is ongoing and additional results are expected to
be published in a peer-reviewed journal.
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. 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 cyclin-dependent kinase (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 is progression-free survival (PFS) in the overall patient population
and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary
endpoints include evaluation of overall survival (OS), objective response rate
(ORR), and duration of response (DOR).
About Menarini
The Menarini Group is a leading international pharmaceutical and diagnostics
company, with a turnover of $4.2 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 10
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's 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
endocrine and metabolic orphan diseases, initially targeting Prader-Willi
Syndrome.
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 timing of publication of the EMERALD Phase 3
topline results; 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, 2020 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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