PR99053

Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant's PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting

FLORENCE, Italy, November, 30, 2022, /PRNewswire=KYODO JBN/--

•        Elacestrant demonstrated longer progression-free survival (PFS) vs SOC

endocrine therapy with medians up to 8.6 months, positively associated with the

duration of prior treatment with CDK4/6 inhibitors

•        Elacestrant side effects were manageable and consistent with previously

reported results

•        Results demonstrate that elacestrant may have the potential to become a new

standard of care as a monotherapy endocrine sequencing option in ER+, HER2-

advanced or metastatic breast cancer after progression on CDK4/6i

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

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

subsidiary of the Menarini Group, will present additional data from the Phase 3

EMERALD study (NCT03778931) of elacestrant, an investigational oral SERD,

during the upcoming San Antonio Breast Cancer Symposium (SABCS) being held from

December 6-10.

EMERALD is a Phase 3 registrational trial that demonstrated statistically

significant progression-free survival (PFS) with elacestrant vs SOC endocrine

monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both

primary endpoints in all patients and in those patients harbouring ESR1

mutations (ESR1-mut), following progression on prior CDK4/6 inhibitors

(CDK4/6i) in ER+, HER2- advanced or metastatic breast cancer.

A post-hoc analysis of the PFS results in the EMERALD trial based on the

duration of prior CDK4/6i usage shows clinically meaningful results which favor

monotherapy elacestrant, both in the total patient population as well as in

patients with ESR1-mut. Increased duration of prior CDK4/6i in metastatic

patients was positively associated with longer PFS on elacestrant but not with

SOC.

For those who were exposed to CDK4/6i >/= 12 months prior to randomization on

EMERALD, elacestrant achieved:

•        In the all-patient population, a mPFS of 3.8 months on elacestrant vs 1.9

months on SOC, a 39% reduction in the risk of progression or death (HR=0.61 95%

CI: 0.45-0.83)

•        In the ESR1-mut population, a mPFS of 8.6 months on elacestrant vs 1.9 months

on SOC, a 59% reduction in the risk of progression or death (HR=0.41 95% CI:

0.26-0.63)

For those who were exposed with CDK4/6i >/= 18 months prior to randomization

on EMERALD, elacestrant achieved:

•        In the all-patient population, a mPFS of 5.5 months on elacestrant vs 3.3

months with SOC, a 30% reduction in the risk of progression or death (HR=0.70

95% CI: 0.48-1.02)

•         In the ESR1-mut population, a mPFS of 8.6 months on elacestrant vs 2.1

months on SOC, a 53% reduction in the risk of progression or death (HR=0.47 CI:

0.20-0.79).

Updated safety data were consistent with previously reported results. Most of

the adverse events (AEs), including nausea, were grade 1 and 2, and only 3.4%

and 0.9% of the patients discontinued trial therapy because of an AE on

elacestrant and SOC, respectively. A low percentage of patients received an

antiemetic; 8.0% on elacestrant, 3.7% on fulvestrant, and 10.3% on AI,

respectively. No hematological safety signal was observed and none of the

patients in either of the two treatment arms had sinus bradycardia.

Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of

medicine, UT Health San Antonio, MD Anderson Cancer Center, commented, "These

results show that when used as a single agent, elacestrant provided mPFS up to

8.6 months, based on the duration of previous CDK4/6 inhibitor therapy, with a

manageable safety profile and the convenience of an oral tablet. This suggests

elacestrant may have the potential to become a new standard of care as a

monotherapy endocrine sequencing option in ER+, HER2- advanced breast cancer

after progression on CDK4/6i, before moving to combination therapies."

"These results further highlight elacestrant's potential to change the

treatment paradigm of ER+, HER2- advanced or metastatic breast cancer.

Elacestrant is under Priority Review with the U.S. Food and Drug Administration

(FDA) with a target PDUFA date of February 17, 2023," commented Elcin Barker

Ergun, Chief Executive Officer of the Menarini Group.

A complete list of key Menarini Group presentations at SABCS is below.

The Menarini Group obtained global licensing rights for elacestrant in July

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

EMERALD study. 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 478 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 endpoints of the study were

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 and oncology. Radius' lead product,

TYMLOS (R) (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 and the investigational drug, elacestrant (RAD1901), for potential

use in the treatment of hormone-receptor positive breast cancer out-licensed to

Menarini Group.

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SOURCE: Menarini Industrie Farmaceutiche Riunite