Abemaciclib

Preliminary efficacy analysis from the elacestrant plus everolimus and ribociclib cohorts of the ELEVATE study, along with updated safety data from additional cohorts of elacestrant plus targeted therapy combination arms, will be presented. These data highlight elacestrant’s potential role as an endocrine therapy backbone in combination with various targeted agents for patients with ER+/HER2- mBC. The robust elacestrant clinical development program across wide-ranging studies further solidifies its potential in monotherapy and combination settings, in mBC and in early breast cancer. FLORENCE, Italy and NEW YORK, May 22, 2025 (GLOBE NEWSWIRE) -- The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present updated preliminary efficacy and safety results from the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes. Additionally, various other trial-in-progress updates will be presented, investigating elacestrant’s potential to become an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study is comprised of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. A recommended phase 2 dose (RP2D) was determined to be elacestrant 345 mg plus ribociclib 400 mg. The RP2D of elacestrant 345 mg plus everolimus 7.5 mg was previously reported. “It is encouraging to see the positive preliminary efficacy and safety results when everolimus and ribocilib, respectively, are combined with elacestrant. These findings are consistent with the promising elacestrant plus abemaciclib cohort data from the same study that was presented last December, which also demonstrated favorable preliminary efficacy and safety in this setting,” said Hope S. Rugo, MD, Director, Women's Cancers Program and Division Chief, Breast Medical Oncology, City of Hope Comprehensive Cancer Center. “As the progression-free survival data and safety data continue to mature across the various cohorts of the ELEVATE study, we are encouraged by elacestrant’s potential to become an endocrine therapy backbone in combination regimens for the treatment of metastatic breast cancer.” Additional data reported separately (abstract 1079/58) provided updated Phase 1b/2 safety results from four cohorts of the ELEVATE study, including elacestrant plus ribociclib, everolimus, alpelisib, and capivasertib. These updated preliminary results show that the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. “These data continue to underscore the potential value of elacestrant as a combination partner in the ER+/HER2- metastatic breast cancer treatment landscape,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are also exploring the potential of elacestrant in other patient populations, including our currently enrolling ELEGANT study, which is designed to assess its potential benefit in early breast cancer patients with high risk of recurrence.” In addition, the company will be presenting other data at the ASCO Annual Meeting. See below for a complete list of Menarini Stemline abstracts. Menarini Stemline Abstracts: Presentation Title: Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1070 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 49 Presenting Author: Hope S. Rugo Presentation Title: Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. Abstract Number: 1079 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 58 Presenting Author: Nancy Chan Presentation Title: ADELA: a double-blind, placebo-controlled, randomized phase 3 trial of Elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. Abstract Number: TPS1129 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 103b Presenting Author: Antonio Llombart-Cussac Presentation Title: ELCIN: Elacestrant in women and men with CDK4/6 Inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): an open-label multicenter phase 2 study. Abstract Number: TPS1127 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 102b Presenting Author: Virginia G. Kaklamani Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen Receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. Abstract Number: TPS619 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210a Presenting Author: Aditya Bardia Presentation Title: EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA) Abstract Number: TPS620 Presentation Date & Time: Monday, June 2, 9:00 AM – 12:00 PM CT Location: Poster Bd 210b Presenting Author: Michail Ignatiadis About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, 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 an open-label phase 1b/2, multicenter 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-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC 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 as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: 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, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Full prescribing information for the U.S. can be found at www.orserdu.com . Important Safety Information Warning and Precautions Dyslipidemia : Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity : Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive 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 who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received 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 flush (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 Lactation : Advise lactating women to not 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, 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, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Media Contacts The Menarini Group Valeria Speroni Cardi Email: pressoffice@menarini.com Stemline Therapeutics, Inc. Cheya Pope Email: media@menarinistemline.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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Caris Life Sciences and the Caris POA collaborators will collectively present 37 abstracts IRVING, Texas, May 22, 2025 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (Caris POA) will collectively present 37 abstracts across 16 tumor types at the upcoming 2025 American Society of Clinical Oncology Annual Meeting, from May 30 – June 3, in Chicago, IL. Continue Reading "This year's ASCO abstracts highlight the growing clinical value of integrated molecular profiling and real world data, particularly as AI tools transform how we diagnose and treat cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The data from our internal and collaborative studies show that we are entering a new era of precision oncology, where every data point can support smarter, more personalized decision-making." Caris Life Sciences and the Caris POA collaborators will collectively present 37 abstracts across 16 tumor types Post this "Caris' strong presence at ASCO demonstrates our ongoing commitment to revolutionizing healthcare and improving patient outcomes," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance. "Caris' comprehensive clinicogenomic database helps enable novel insights into cancer and, together with our network of Caris POA researchers, is truly making an impact on patients' diagnosis, prognosis, care plans and responses to treatment." Oral presentation: CLONEVO: Preoperative abemaciclib for cisplatin-ineligible muscle-invasive bladder cancer (MIBC) with molecular response assessment. (Abstract 4520) May 31, 2:15 – 2:21 PM CDT: Arie Crown Theater Poster presentations: Assessment of age in the clinical risk stratification of patients with IDH-mutant gliomas. Abstract: 2058 Poster Board: 104 May 31, 9:00 AM CDT: Hall A Comparing ERK signaling and tumor microenvironment in BRAF-altered gliomas. Abstract: 2063 Poster Board: 109 May 31, 9:00 AM CDT: Hall A Association of MGMT status with survival in low and high-grade IDH-mutant astrocytomas. Abstract: 2065 Poster Board: 111 May 31, 9:00 AM CDT: Hall A Prognostic impact of DDR mutations (mt) in IDH mutant high-grade gliomas (HGG). Abstract: 2066 Poster Board: 112 May 31, 9:00 AM CDT: Hall A Immune checkpoint inhibition in EBV-associated gastric cancer: A multi-center international retrospective analysis. Abstract: 4043 Poster Board: 333 May 31, 9:00 AM CDT: Hall A Molecular profile of hepatocellular carcinoma (HCC) in older (OA) versus younger adults (YA) receiving tyrosine kinase inhibitors: Does age matter? Abstract: 4124 Poster Board: 414 May 31, 9:00 AM CDT: Hall A The differential effect of stromal genes on gemcitabine/nab-paclitaxel (GN) and GN/cisplatin (GCN) outcomes in advanced pancreatic adenocarcinoma (aPDAC). Abstract: 4166 Poster Board: 456 May 31, 9:00 AM CDT: Hall A Biomarkers of response to immunotherapy in pancreatic ductal adenocarcinoma (PDAC) with homologous recombination deficiency (HRD). Abstract: 4176 Poster Board: 466 May 31, 9:00 AM CDT: Hall A Gamma secretase inhibitors and desmoid fibromatosis: Lessons from a real world, comprehensive genomic study of desmoids and CTNNB1/APC mutated soft tissue tumors. Abstract: 11547 Poster Board: 30 May 31, 9:00 AM CDT: Hall A Unveiling drivers of MHC repression and therapeutic strategies to counter immune evasion in small cell lung cancer. Abstract: 8091 Poster Board: 212 May 31, 1:30 PM CDT: Hall A Clinical outcomes and characterization of HER2 alterations in non-small cell lung cancer (NSCLC). Abstract: 8538 Poster Board: 18 May 31, 1:30 PM CDT: Hall A PRESCIENTai, an AI-based digital histopathological image signature for risk of late distant recurrence and extended endocrine therapy (EET) benefit in hormone-receptor-positive breast cancer. Abstract: 1556 Poster Board: 322 June 1, 9:00 AM CDT: Hall A Interferon signaling and outcomes in triple-negative breast cancer (TNBC) in FinXX, CALGB 40603 (Alliance) and real-world clinico-genomic data. Abstract: 569 Poster Board: 162 June 2, 9:00 AM CDT: Hall A MHC class I expression and outcomes in breast cancer in the real-world clinico-genomic data and the FinXX trial. Abstract: 570 Poster Board: 163 June 2, 9:00 AM CDT: Hall A Evaluation of tumor immune microenvironment in Hispanic and African American breast cancer. Abstract: 1051 Poster Board: 30 June 2, 9:00 AM CDT: Hall A Comparing clinical benefit of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in a large cohort of HER2-negative metastatic breast cancer (MBC). Abstract: 1076 Poster Board: 55 June 2, 9:00 AM CDT: Hall A Steroid receptor expression and overall survival in breast cancer patients with ER+ bone metastasis: A retrospective review. Abstract: 1077 Poster Board: 56 June 2, 9:00 AM CDT: Hall A Multiomic Profiling of LRRC15 in Triple Negative Breast Cancer (TNBC). Abstract: 1098 Poster Board: 77 June 2, 9:00 AM CDT: Hall A Chemokines as predictive biomarkers for immune checkpoint inhibitor (ICI) benefit in triple negative breast cancer (TNBC). Abstract: 1106 Poster Board: 85 June 2, 9:00 AM CDT: Hall A Comprehensive molecular and immune characterization of adrenergic stress-signaling receptor ADRB2 in triple negative breast cancer (TNBC). Abstract: 1107 Poster Board: 86 June 2, 9:00 AM CDT: Hall A Comprehensive characterization of interleukin-enhanced factor 2 (ILF2) in triple-negative breast cancer (TNBC). Abstract: 1114 Poster Board: 93 June 2, 9:00 AM CDT: Hall A HIF family transcription factor expression in a cohort of 4362 patients with renal cell carcinoma (RCC). Abstract: 4543 Poster Board: 343 June 2, 9:00 AM CDT: Hall A Real-world analysis of 2IR immune response score in histologic subtype urothelial carcinoma (hsUC). Abstract: 4568 Poster Board: 368 June 2, 9:00 AM CDT: Hall A Prevalence of histology-agnostic biomarkers in pure squamous cell carcinomas of the genitourinary tract. Abstract: 4609 Poster Board: 409 June 2, 9:00 AM CDT: Hall A Comprehensive genomic profiling of Black and non-Hispanic White (NHW) men with prostate cancer (PCa). Abstract: 5022 Poster Board: 221 June 2, 9:00 AM CDT: Hall A Effect of HLA class I expression on the tumor immune microenvironment and prognosis in prostate cancer. Abstract: 5044 Poster Board: 243 June 2, 9:00 AM CDT: Hall A Molecular and clinical characterization of KLK2 mRNA expression in prostate cancer (PC). Abstract: 5050 Poster Board: 249 June 2, 9:00 AM CDT: Hall A Prognostic relevance of Aurora kinase A (AURKA) expression in prostate cancer (PCa). Abstract: 5061 Poster Board: 260 June 2, 9:00 AM CDT: Hall A Molecular characterization of STEAP1 and -2 in advanced prostate cancer. Abstract: 5072 Poster Board: 271 June 2, 9:00 AM CDT: Hall A Characterization and impact of B7-H3 (CD276) expression across disease states and racial groups in prostate cancer. Abstract: 5073 Poster Board: 272 June 2, 9:00 AM CDT: Hall A Survival association of PIK3CA in HPV-driven head and neck squamous cell carcinoma (HNSCC). Abstract: 6056 Poster Board: 464 June 2, 9:00 AM CDT: Hall A Comparative transcriptomic analysis to identify similarities and therapeutic vulnerabilities in olfactory neuroblastoma (ONB), sinonasal neuroendocrine carcinoma (SNEC) and sinonasal undifferentiated carcinoma (SNUC). Abstract: 6095 Poster Board: 503 June 2, 9:00 AM CDT: Hall A BRAF -V600E papillary thyroid cancer: Updated analysis of real-world patient data. Abstract: 6099 Poster Board: 507 June 2, 9:00 AM CDT: Hall A Clinical significance of the CGRP pathway gene expression in advanced solid tumors: A sub-analysis of MONSTAR-SCREEN-2. Abstract: 2629 Poster Board: 276 June 2, 1:30 PM CDT: Hall A Effect of elevated expression of LILRB4 and TSC22D3 on survival in lung cancer. Abstract: 2633 Poster Board: 280 June 2, 1:30 PM CDT: Hall A Regorafenib response prediction in metastatic colorectal cancer by a novel genomic and transcriptomic model. Abstract: 3135 Poster Board: 450 June 2, 1:30 PM CDT: Hall A Poster and abstract summaries highlighting this research will be available onsite at Caris' booth #23093. The full abstracts will be available on the Caris website following the presentation. The Caris POA, a community of investigators, includes 97 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED