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STATEMENT: Menarini Group announces new data on ORSERDU® (elastrant) (1)

- Menarini Group Announces New Data on ORSERDU® (elastrant) at the 2023 San Antonio Breast Cancer Symposium and on ELZONRIS® (tagraxofusp-erzs) at the 65th Annual Meeting & Exposition of the American Society of Hematology.

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STATEMENT: Menarini Group announces new data on ORSERDU® (elastrant) (1)

- Menarini Group Announces New Data on ORSERDU® (elastrant) at the 2023 San Antonio Breast Cancer Symposium and on ELZONRIS® (tagraxofusp-erzs) at the 65th Annual Meeting & Exposition of the American Society of Hematology

- Data span 11 presentations of solid tumors and hematologic malignancies, providing greater understanding of the potential benefit these therapies bring to patients.

- ORSERDU data reinforce its key role in the treatment of advanced or metastatic ER, HER2- breast cancer (mBC) tumors harboring ESR1 mutations, while also showing initial data from pooled trials.

- The ELZONRIS presentation includes updated real-world data from patients with blastic plasmacytoid dendritic cell neoplasia.

FLORENCE, Italy and NEW YORK, Nov. 21, 2023 /PRNewswire/ -- Menarini Group ("Menarini"), a leading pharmaceutical and diagnostics company in Italy, and Stemline Therapeutics, Inc. ("Stemline"), a subsidiary of wholly owned Menarini Group focused on providing transformational oncology treatments to cancer patients, announced today that they will present new data related to ORSERDU® (elacestrant) and ELZONRIS® (tagraxofusp-erzs) at two upcoming conferences.

ORSERDU, a once-daily oral endocrine monotherapy, for the treatment of postmenopausal women or adult men with advanced or metastatic breast cancer with ER, HER2-, ESR1 mutations and disease progression after at least one line of endocrine therapy, It was approved by the US Food and Drug Administration in January 2023 under its priority review and fast track designation. In September 2023, ORSERDU was approved by the European Commission.

Updated data, including a featured discussion on additional biomarkers and clinical subgroup analyzes from the Phase 3 EMERALD trial, will be presented at the San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023. along with new safety updates that evaluate elacestrant in multiple combination settings.

ELZONRIS was approved by the FDA in December 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasia (BPDCN) in adult and pediatric patients aged two years and older, in both treatment-naïve and previously treated populations. In January 2021, ELZONRIS was approved by the European Commission. Updated data will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, including an oral presentation of updated real-world results in BPDCN-naïve patients demonstrating durable results and a manageable safety profile leading to to prolonged survival, in San Diego, December 9-12, 2023.

"The breadth of data on our novel oncology therapies, spanning solid tumors and hematologic malignancies, underscores our commitment to addressing important unmet medical needs in difficult-to-treat cancers," said Elcin Barker Ergun, CEO of Menarini Group. "At Menarini Stemline, we are dedicated to driving innovation in oncology to deliver targeted therapies that bring value to people living with cancer and the healthcare providers who care for them."

See full details of upcoming Menarini Group/Stemline Therapeutics presentations below:

San Antonio Breast Cancer Symposium 2023

* Denotes research sponsored by a researcher or collaborative research.

65th Annual Meeting of the American Society of Hematology (ASH) 2023

* Denotes research sponsored by a researcher or collaborative research.

About the EMERALD Phase 3 Study (NCT03778931)

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/mBC. The study included 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Study patients were randomly assigned to receive elacestrant or an approved hormonal agent, chosen by the investigator. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with mutations in the estrogen receptor 1 (ESR1) gene. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months versus 1.9 months in SOC, and reduced the risk of progression or death by 45% (PFS HR=0 .55, 95% CI: 0.39, 0.77) vs. SOC.

About ORSERDU® (elacestrant)

US Indication: ORSERDU (elacestrant), 345 mg tablets, is approved by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women or adult men with advanced or metastatic breast cancer. with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, ESR1 mutation negative, and disease progression after at least one line of endocrine therapy.

Complete prescribing information for the US can be found at www.orserdu.com.

Important safety information, ORSERDU®

Warning and precautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU with an incidence of 30% and 27%, respectively. The incidence of grade 3 and 4 hypercholesterolemia and hypertriglyceridemia was 0.9% and 2.2%, respectively. Monitor lipid profile before starting and periodically while taking ORSERDU.

Embryo-fetal toxicity: Based on findings in animals and its mechanism of action, ORSERDU may cause fetal harm when administered to a pregnant woman. Inform pregnant women and women of reproductive age about the potential risk to the fetus. Advise women of childbearing potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of childbearing potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose.

Adverse reactions

Serious adverse reactions occurred in 12% of patients receiving ORSERDU. Serious adverse reactions in >1% of patients receiving ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients receiving ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).

The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%) , decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flashes (11%) and dyspepsia (10%).

Interactions with other medications

Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.

Use in specific populations

Breastfeeding: Advise nursing women not to breastfeed during treatment with ORSERDU and for 1 week after the last dose.

Hepatic impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).

The safety and effectiveness of ORSERDU in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Elacestrant is also being investigated in several clinical trials in metastatic breast cancer, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108), and ELCIN (NCT05596409). Elacestrant is also being evaluated in early breast cancer disease.

About ELZONRIS® (tagraxofusp-erzs)

US Indication: ELZONRIS (tagraxofusp-erzs) is a prescription medication used to treat blastic plasmacytoid dendritic cell neoplasia (BPDCN) in adults and pediatric patients aged 2 years and older.

Complete prescribing information for the US can be found at www.elzonris.com.

IMPORTANT SAFETY INFORMATION, ELZONRIS®

Boxed WARNING: HAIR LEAK SYNDROME

Capillary leak syndrome (CLS), which can be life-threatening or fatal, may occur in patients receiving ELZONRIS. Be aware of the signs and symptoms of CLS and take the recommended measures.

Notices and precautions

capillary leak syndrome

Capillary leak syndrome (CLS), including fatal and life-threatening cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8 /122) of patients, Grade 4 in 1% (1/122) of patients, and four deaths (3%). The median time to onset was 4 days (range: 1 to 46 days) and all but 5 patients experienced an event in cycle 1.

Before starting treatment with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as clinically indicated thereafter, and evaluate patients for other signs or symptoms of CLS, including weight gain, new onset or worsening of edema, including pulmonary edema, hypotension. or hemodynamic instability.

Hypersensitivity reactions

ELZONRIS may cause serious hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of ELZONRIS-treated patients and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Discontinue the ELZONRIS infusion and provide supportive care as necessary if a hypersensitivity reaction occurs.

Hepatotoxicity

Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, ALT elevations occurred in 79% (96/122) and AST elevations occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and grade 4 AST elevations in 3% (4/122) of patients. Elevations in liver enzymes occurred in the majority of patients in cycle 1 and were reversible upon dose interruption.

Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) before each infusion with ELZONRIS. Discontinue ELZONRIS temporarily if transaminases increase to more than 5 times the upper limit of normal and resume treatment when normalized or resolved.

Adverse reactions

The most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight gain. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT, and AST.

See full prescribing information, including the WARNING on the box.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Menarini Group

Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of more than $4.4 billion and more than 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information, visit www.menarini.com.

About Stemline Therapeutics Inc.

Stemline Therapeutics, Inc. ("Stemline"), a wholly owned subsidiary of Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapies. Stemline markets ORSERDU® (elacestrant) in the US and EU, an oral endocrine therapy indicated for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive postmenopausal women or adult men. negative, ESR1- mutated advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy. Stemline also markets ELZONRIS® (tagraxofusp-erzs), a novel CD123-targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasia (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also markets NEXPOVIO® (selinexor), an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical portfolio of small molecules and biologics in various stages of development for a variety of solid and hematologic cancers.

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