22.07.2023 – 00:39
Menarini Pharmaceutical Industries United
FLORENCE, Italy, and New York, April 20 /PRNewswire/
More than 550,000 patients are diagnosed with breast cancer each year in Europe, 70% of whom are Estrogen Receptor (ER) positive(¹); more than 147,000 breast cancer patients in Europe die from the disease annually(²)If ORSERDU is approved by the European Commission, it would be the first and only treatment specifically indicated for patients with ER+, HER2-advanced or metastatic breast cancer tumors with ESR1 mutationsESR1 mutations occur in up to 40% of ER+, HER2-advanced or metastatic breast cancers and are a known Cause resistance to standard endocrine therapies, making these tumors difficult to treat.
Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. (“Stemline”), a wholly owned subsidiary of Menarini Group, announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the approval of ORSERDU® (elacestrant) as monotherapy. ORSERDU® (elacestrant) is indicated for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation, whose disease has progressed after at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The CHMP opinion will now be examined by the European Commission, which is responsible for granting marketing authorizations for medicines for human use throughout the European Union (EU). If approved, Stemline and its subsidiaries will commercialize the product in Europe. ORSERDU would be the first and only therapy indicated specifically for the treatment of ER+, HER2 tumors harboring ESR1 mutations. ESR1 mutations are acquired mutations that develop as a result of endocrine therapy and occur in up to 40% of patients with ER+, HER2- and mBC. ESR1 mutations are a well-known cause of resistance to standard endocrine therapies, and until now, tumors harboring these mutations have been more difficult to treat.
“Patients with metastatic breast cancer need effective and tolerable treatment options. If approved by the European Commission, ORSERDU could be the first product indicated in ER+, HER2- and advanced breast cancer with ESR1 mutations, which confer strong resistance to treatment in up to 40% of patients in second-line mBC therapy. ORSERDU, if approved, will also enable convenient daily oral treatment,” said Elcin Barker Ergun, CEO of Menarini Group. “We are proud of today’s positive CHMP opinion as it reflects our commitment to developing innovative solutions that address the greatest unmet need in cancer therapy and brings us one step closer to providing an important new option for the patients and families affected by ESR1 mutant, ER+, HER2 metastatic breast cancer are.”
The positive CHMP opinion on ORSERDU is based on data from the phase 3 EMERALD study, which showed statistically significant progression-free survival (PFS) with elacestrant compared to standard of care (SOC), ie an approved endocrine monotherapy of the investigator’s choice. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months versus 1.9 months with SOC and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) versus SOC.
A post hoc subgroup analysis of EMERALD PFS results presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) showed that duration of prior CDK4/6i treatment was positively associated with longer PFS on elacestrant but not with SOC. In patients with ESR1 mutations treated with CDK4/6i for ≥12 months prior to randomization in the EMERALD study, elacestrant achieved a median PFS of 8.6 months versus 1.9 months at SOC, with a 59% reduction in risk of progression or death (HR=0.41 95% CI: 0.26-0.63).(³)
“As an oncologist, it is remarkable that we are on the cusp of becoming the first treatment option for patients with advanced or metastatic ER+, HER2 breast cancer who have ESR1 mutations, which occur in up to 40% of patients in the metastatic setting,” said Giuseppe Curigliano, MD, PhD, Professor of Medical Oncology at the University of Milan and Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, in Italy has been shown to be effective and has a manageable safety profile, underscoring the potential benefits this therapy could soon bring to the patients we serve and to the broader oncology community.”
The safety data were consistent with previously reported results. Serious adverse reactions reported in ≥1% of patients included nausea, dyspnoea and thromboembolism (venous). The most common (≥10%) adverse reactions to ORSERDU were nausea, increased triglycerides, increased cholesterol, vomiting, fatigue, dyspepsia, diarrhea, decreased calcium, back pain, increased creatinine, arthralgia, decreased sodium, constipation, headache, flushing, abdominal pain, anemia, decreased potassium, and increased alanine aminotransferase. The most common Grade ≥3 (≥2%) adverse reactions to elacestrant were nausea (2.7%), AST increased (2.7%), ALT increased (2.3%), anemia (2%), back pain (2%), and bone pain (2%).
About the EMERALD Phase 3 Trial (NCT03778931)
The phase 3 EMERALD study is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2-advanced/metastatic breast cancer. The study enrolled 478 patients who had been previously treated with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Study participants were randomly assigned to receive either elacestrant or an approved hormonal agent of the investigator’s choice. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene mutations (ESR1). In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months versus 1.9 months with SOC and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) versus SOC.
Elacestrant is also being studied in several clinical trials for the treatment of metastatic breast cancer, alone or in combination with other therapies: ELEVATE (NCT05563220), Electra (NCT05386108), and ELCIN (NCT05596409). Elacestrant is also to be studied in early-stage breast cancer.
The Menarini Group was granted global license rights to elacestrant from Radius Health July 2020, Inc. Menarini Group is now fully responsible for global registration, commercialization and further development activities for elacestrant.
About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company with revenues of over $4.4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet needs with products in cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production sites and 9 R&D centers, Menarini products are available in 140 countries worldwide. Visit www.menarini.com for more information.
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 therapeutics. Stemline commercializes in the United States ORSERDU® (elacestrant), an oral endocrine drug for the treatment of postmenopausal women or adult men with estrogen receptor (ER) positive human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed after at least one endocrine therapy Stemline also commercializes ELZONRIS® (Tagraxofusp-Erzs), a novel targeted treatment targeting CD123 and approved for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe. ELZONRIS is the only approved treatment for BPDCN in the US and EU to date. Stemline also markets Nexpovio®, an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical pipeline of small molecule and biologics in various stages of development for a range of solid and hematologic cancers.
(¹) Decision Resource Group / Clarivate Breast Cancer Landscape / Epidemiology – 14. Juni 2023
(²) International Agency for Research on Cancer, World Health Organization – Globocan – 2020
(³) Bardia et al. EMERALD Phase 3 Trial of Elacestrant Compared to Standard Endocrine Therapy in Patients With ER+/HER2- Metastatic Breast Cancer: Updated Results by Duration of Prior CDK4/6i Treatment in Metastatic Breast Cancer. SABCS 2022. GS3-01
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