RELEASE: Menarini Group Presents Updated Results from the EMERALD Phase 3 Pivotal Trial at SABCS (1)

(Information sent by the signatory company).

RELEASE: Menarini Group Presents Updated Results from the EMERALD Phase 3 Pivotal Trial at SABCS (1)

(Information sent by the signatory company)

-Menarini Group presents updated results from the pivotal Phase 3 EMERALD trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) demonstrating that Elacestrant PFS increases with duration of prior CDK4/6i in ER , HER2- in the metastatic environment

FLORENCE, Italy, Dec. 3, 2022 /PRNewswire/ -- Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly owned subsidiary of Menarini Group , will present additional data from the Phase 3 EMERALD (NCT03778931) study of elacestrant, an investigational oral SERD, during the upcoming San Antonio Breast Cancer Symposium (SABCS) to be held December 6-10.

EMERALD is a Phase 3 registration trial that demonstrated statistically significant progression-free survival (PFS) with elacestrant versus SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both primary endpoints across all trials. patients and those harboring ESR1 mutations (ESR1-mut), after progression with prior CDK4/6 inhibitors (CDK4/6i) in ER , HER2-advanced or metastatic breast cancer.

A post-hoc analysis of PFS results in the EMERALD trial based on duration of prior CDK4/6i use shows clinically significant results favoring elacestrant monotherapy, both in the total patient population and in ESR1 patients. -mut. Longer duration of prior CDK4/6i use in metastatic patients was positively associated with longer PFS with elacestrant, but not with SOC.

For patients exposed to CDK4/6i ≥12 months prior to randomization into EMERALD, elacestrant achieved:

For those who were challenged with CDK4/6i ≥18 months prior to randomization into EMERALD, elacestrant achieved:

Across the entire patient population, an mPFS of 5.5 months with elacestrant vs. 3.3 months with SOC, a 30% reduction in risk of progression or death (HR=0.70 95% CI: 0.48 -1.02)

· In the ESR1-mut population, an mPFS of 8.6 months with elacestrant vs. 2.1 months with SOC, a 53% reduction in the risk of progression or death (HR=0.47 CI: 0.20- 0.79).

The updated safety data was consistent with previously reported results. Most adverse events (AEs), including nausea, were grade 1 and 2, with only 3.4% and 0.9% of patients discontinuing trial treatment due to an AE with elacestrant and SOC , respectively. A low percentage of patients received an antiemetic; 8.0% with elacestrant, 3.7% with fulvestrant, and 10.3% with IA, respectively. No haematological safety signal was observed and none of the patients in either of the two treatment arms developed sinus bradycardia.

Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of medicine at UT Health San Antonio MD Anderson Cancer Center, commented: "These results show that when used as a single agent, elacestrant provided mPFS of up to 8.6 months, based on the duration of prior CDK4/6 inhibitor treatment, with a manageable safety profile and the convenience of an oral tablet, suggesting that elacestrant may have the potential to become a new standard of care as a monotherapy option for Endocrine sequencing in ER, HER2- advanced breast cancer after progression to CDK4/6i, before moving to combination therapies."

"These results highlight the potential of elacestrant to change the paradigm of treatment of ER , HER2-advanced or metastatic breast cancer. Elacestrant is currently undergoing priority review by the US Food and Drug Administration ( FDA), with an expected PDUFA date of February 17, 2023," said Elcin Barker Ergun, CEO of the Menarini Group.

Below is a full list of the Menarini Group's top presentations at SABCS.

The Menarini Group obtained the worldwide license rights to elacestrant in July 2020 from Radius Health, Inc. which conducted and successfully completed the EMERALD study. The Menarini Group is now fully responsible for the global registration, commercialization and further development activities of elacestrant.

About Elacestrant (RAD1901) and the Phase 3 EMERALD 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 Phase 3 EMERALD trial is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in patients with ER , HER2- advanced/metastatic breast cancer. The study included 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 randomly assigned to receive elacestrant or the approved hormonal agent chosen by the investigator. The primary endpoints of the study were progression-free survival (PFS) in the general patient population and in patients with estrogen receptor 1 (ESR1) gene mutations. Secondary endpoints included assessment of overall survival (OS), objective response rate (ORR), and duration of response (DOR), and safety.

About Menarini Group Menarini Group is a leading international pharmaceutical and diagnostics company with revenues of more than $4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production plants and 9 research and development centers, Menarini products are available in 140 countries around the world. For more information, visit www.menarini.com.

About Stemline

Stemline Therapeutics, a subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer therapies. Stemline markets a novel CD123-targeted therapy for patients with 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 a broad portfolio of small molecules and biologics in various stages of development for a range of solid and hematologic cancers.

About Radius

Radius is a global biopharmaceutical company focused on meeting unmet medical needs in bone health and oncology. Radius' lead product, TYMLOS® (abaloparatide) injection, has been approved by the US Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk of fracture. Radius' clinical product portfolio includes investigational abaloparatide injection for possible use in the treatment of men with osteoporosis and investigational drug, elacestrant (RAD1901), for possible use in the treatment of hormone receptor-positive breast cancer. positives licensed to the Menarini Group.

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