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Menarini Group Presents Updated Data from the ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU) in Patients With ER, HER2- Metastatic Breast Cancer (mBC) at ASCO 2024 Annual Meeting
FLORENCE, Italy and NEW YORK, May 24, 2024/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, will present updated results from the Phase 1b/2 ELECTRA and ELEVATE clinical studies evaluating elacestrant (ORSERDU) in combination with other treatments. Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor (ER)-positive, HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through new combined oral-oral treatment options. The data will be presented at the American Society of Clinical Oncology (ASCO) 2024, June 2 from 9 a.m. to 12 p.m. CT.
The ELECTRA study is evaluating elacestrant in combination with abemaciclib in patients with ER, HER2- metastatic breast cancer with brain metastases; however, the phase 1b portion of this study was performed on all metastatic sites, including brain metastases. Updated Phase 1b results continue to show a satisfactory safety profile, consistent with previous findings, and promising activity in patients with ER, HER2- advanced, or mBC, regardless of metastatic site. Based on the results of this part of the study, the recommended phase 2 dose (RP2D) will be reported as part of the data presentation. Phase 2 of ELECTRA is currently ongoing in the RP2D to better characterize the efficacy and safety in patients with ER, HER2- metastatic breast cancer with brain metastases, as both elacestrant and abemaciclib cross the blood-brain barrier.
“It is encouraging to see that, even in the early stages of the trial, the combination of elacestrant plus abemaciclib indicates a tolerable and manageable safety profile for patients in the clinical trial,” explained Erika Hamilton, MD, director of Breast Cancer Research and executive chair of the Sarah Cannon Research Institute Breast Cancer Research Executive Committee. “The study continues to demonstrate the potential of elacestrant in combination with other therapies and we look forward to analyzing more data from this combination for this patient population in need of new options.”
The ELEVATE study evaluates elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with PI3K/AKT/mTOR pathway inhibitors (everolimus, alpelisib and capivasertib). Updated Phase 1b results show that the combinations evaluated are consistent with the known safety profiles of each targeted therapy plus standard-of-care endocrine therapy. Based on the results of this part of the study, the RP2D for elacestrant in combination with everolimus will be reported. Additional cohorts, including elacestrant plus capivasertib, are currently being evaluated to better characterize safety, evaluate efficacy, and determine RP2D for each combination group. Phase 2 for the combination of elacestrant and abemaciclib in ER, HER2- metastatic breast cancer, regardless of metastatic site, is now underway.
“As we evaluate the various combinations of elacestrant plus CDK4/6 and PI3K/AKT/mTOR inhibitors, we continue to see consistent and manageable safety findings across all arms of the trial and, so far, elacestrant does not appear to add any incremental toxicity to combination regimens that are being studied,” said Hope S. Rugo, MD, professor of medicine and Winterhof Family Professor of Breast Cancer, director of breast oncology education and clinical trials at the University of California, San Francisco. . “These data build on our understanding of elacestrant’s role in metastatic breast cancer and reinforce its potential as a backbone of endocrine therapy in combination regimens.”
“Since its approval in 2023, ORSERDU has had a significant impact as an endocrine therapy for people living with ER, HER2- metastatic breast cancer harboring ESR1 mutations,” said Elcin Barker Ergun, CEO of Menarini Group. “The data we are presenting at ASCO highlight the potential for elacestrant to further improve patient outcomes when combined with other compounds.”
About Elacestrant’s clinical development program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer, alone or in combination with other therapies. ELEVATE ( NCT05563220) is a Phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib, or abemaciclib. 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 patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3, randomized, double-blind trial evaluating elacestrant in combination with everolimus in patients with mBC ER, HER2- with ESR1-mut tumors. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer and in early disease.
About ORSERDU (elacestrant) Indication for the United States: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with advanced or metastatic breast cancer with a mutation in the epidermal growth factor receptor ESR1. human 2 (HER2) positive, estrogen receptor (ER) positive, with disease progression after at least one line of endocrine therapy.
Complete prescribing information for the United States is available at www.orserdu.com.
Important Safety InformationWarnings 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%).
Drug interactions
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 on the website at www.fda.gov/medwatch.
About Menarini GroupMenarini Group is a leading international pharmaceutical and diagnostics company with revenue of $4.7 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 who are estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, ESR1- Advanced or metastatic 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 the United States. 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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