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- Menarini Group presented initial safety and efficacy data from the combined Phase 1b/2 ELEVATE and ELECTRA studies of ORSERDU® (Elacestrant) in patients with ER, HER2- metastatic breast cancer (mBC) at the Breast Cancer Symposium in San Antonio 2023
FLORENCE, Italy and NEW YORK, Dec. 12, 2023 /PRNewswire/ -- Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a subsidiary wholly owned Menarini Group, focused on providing transformational oncology treatments to cancer patients, presented results from the Phase 1b/2 ELEVATE and ELECTRA clinical studies evaluating ORSERDU® (elacestrant) in combination with other treatments. Both the ELEVATE and ELECTRA studies were designed with the goal of overcoming different mechanisms of resistance and improving patient outcomes with combined treatment options. The data were presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
The ELEVATE study is evaluating elacestrant in combination with PI3K/AKT/mTOR pathway inhibitors (everolimus and alpelisib) and cell cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib). Results reported at SABCS 2023 include all pooled data from Cohort 1 of the Phase 1b study, and the therapies show predictable safety profiles that were consistent with previous studies. Additional cohorts are currently being evaluated to evaluate pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination. The full summary (1576517) can be seen here.
"It is encouraging to see positive initial safety results in several combination studies of ORSERDU, along with promising preliminary efficacy data in these trials," said Hope Rugo, MD, professor of medicine, Division of Hematology and Oncology, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center. "We look forward to learning more about the role of ORSERDU in combination settings and its potential across the spectrum of metastatic breast cancer."
The ELECTRA study is evaluating elacestrant in combination with abemaciclib. Phase 1b of this study will also determine the recommended phase 2 dose (RP2D) of this combination in patients regardless of metastatic sites. Phase 2 will evaluate the benefit of the combination in patients with ER/HER2- advanced or metastatic breast cancer with brain metastases, as both compounds have demonstrated the ability to cross the blood-brain barrier. Results reported at SABCS 2023 include all three dose cohorts from the Phase 1b study, showing a tolerable and manageable safety profile with favorable preliminary efficacy in these patients, regardless of the site of their metastases. All three cohorts were completed without any patients experiencing dose-limiting toxicities. No discontinuations beyond the observation period due to toxicity have been observed in any patient. The most common adverse events were diarrhea, nausea, and neutropenia/decreased neutrophil count. Only neutropenia was associated with grade 3 events with the combination; managed with standard dose reduction of abemaciclib. The full summary (1576518) can be seen here.
"People living with ER metastatic breast cancer often face treatment resistance, creating a significant need for innovative new options," said Elcin Barker Ergun, CEO of Menarini Group. "While these data are preliminary, we are committed to advancing our comprehensive research into ORSERDU in combination with other treatments, to potentially help improve patient outcomes, with the goal of extending and improving the lives of people with this disease. ".
See here for details of the full range of Menarini Group/Stemline Therapeutics presentations at SABCS.
About the Elacestrant clinical development program
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer, alone or in combination with other therapies. ELEVATE ( NCT05563220) is a Phase 1b/2 clinical trial that will evaluate the safety and efficacy of elacestrant combined with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. ELECTRA (NCT05386108) is a multicenter, open-label, phase 1b/2 study evaluating elacestrant in combination with abemaciclib in patients with ER, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in these patients with brain metastases. ELCIN (NCT05596409) is a Phase 2 trial evaluating the efficacy of elacestrant in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer. received one or two prior hormonal therapies and no cyclin-dependent kinase prior targeting CDK4 enzymes and CDK6 inhibitor (CDK4/6i) in the metastatic setting. Elacestrant is also being evaluated in early breast cancer disease.
About ORSERDU (elacestrant)
Indication in the United States: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, breast cancer. advanced or metastatic ESR1 mutated breast with disease progression after at least one line of endocrine therapy.
Complete prescribing information for the United States can be found at www.orserdu.com.
Important safety information Notice 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 (3%), 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 drugs
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 lactating 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.
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 United States and Europe, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, cancer. advanced or metastatic ESR1- mutated 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 United States and the 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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