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