PR97492

Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer

FLORENCE, Italy and NEW YORK, Aug. 19, 2022 / PRNewswire=KYODO JBN/ --

- Elacestrant, if approved, would be the first oral selective estrogen receptor

degrader (SERD) to be available for patients suffering from second-line (2L)

and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the

European Union

- Submission supported by results from the pivotal Phase 3 EMERALD study

showing a statistically significant difference in the efficacy in favor of

elacestrant over current standard-of-care (SOC) medications for both the

overall study population and patients whose tumors harbor an ESR1 mutation

The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and

diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned

subsidiary of the Menarini Group, today announced that EMA has validated the

Marketing Authorization Application (MAA) for elacestrant, a selective estrogen

receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic

breast cancer. Validation of the application confirms the submission is

complete and begins EMA's centralized review procedure.

"There is a major unmet need in the treatment of advanced or metastatic

ER+/HER2- breast cancer after resistance builds in the earlier lines of

treatment" commented Elcin Barker Ergun, Chief Executive Officer of the

Menarini Group. "The acceptance of our application for review by the EMA

represents a significant step for our company and we look forward to working

with the agency to potentially bring elacestrant to patients suffering from

second and third line ER+/HER2- advanced or metastatic breast cancer in Europe."

The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC

endocrine monotherapy (investigators' choice of either fulvestrant or an

aromatase inhibitor) in ER+/HER2- advanced or metastatic breast cancer

patients. The study results were recently published online in the Journal of

Clinical Oncology (JCO) on May 18, 2022. Further post-hoc analysis from the

study will be presented at the European Society for Medical Oncology (ESMO)

Congress 2022 taking place September 9-13, 2022, in Paris, France.

The Menarini Group obtained global licensing rights for elacestrant in July

2020 from Radius Health, Inc, who conducted and successfully completed the

EMERALD study. Based on the positive phase 3 data, Stemline submitted a MAA to

EMA on July 27, 2022. The regulatory review for elacestrant is also underway in

the US as the Food and Drug Administration (FDA) has recently accepted a new

drug application for elacestrant designating a priority review. The Menarini

Group is now fully responsible for global registration, commercialization and

further development activities for elacestrant.

About Elacestrant (RAD1901) and the EMERALD Phase 3 Study

Elacestrant is an investigational selective estrogen receptor degrader (SERD).

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 had 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) and safety.

About The Menarini Group

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 Stemline

Stemline Therapeutics, a wholly-owned subsidiary of The Menarini Group, is a

commercial-stage biopharmaceutical company focused on the development and

commercialization of novel oncology therapeutics. Stemline commercializes a

novel targeted treatment directed to CD123 for patients with blastic

plasmacytoid dendritic cell neoplasm (BPDCN) in the United States and Europe

which is also being evaluated as monotherapy and in combination with other

agents, in additional clinical trials for a variety of other indications.

Stemline has an extensive clinical pipeline of small molecules and biologics in

various stages of development for a host of solid and hematologic cancers.

About Radius

Radius is a global biopharmaceutical company focused on addressing unmet

medical needs in the areas of bone health, neuro-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.

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SOURCE: Menarini Industrie Farmaceutiche Riunite