Ribociclib Succinate

Encouraging safety and preliminary efficacy analysis from the elacestrant and capivasertib Phase 1b regimen of the ELEVATE study will be presented.The efficacy data highlight how the combination of elacestrant and capivasertib has the potential to address key resistance mechanisms for patients with ER+/HER2- mBC, including ESR1 and PIK3CA co-existing mutations. The company will also share updates on its elacestrant clinical development program, underscoring its potential in both mBC combination settings and as a monotherapy in early breast cancer. FLORENCE, Italy and NEW YORK, May 28, 2026 (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 safety and preliminary efficacy for the elacestrant and capivasertib combination arm of the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). Additionally, various other trial-in-progress updates will be presented, underscoring elacestrant’s potential as an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study was designed to evaluate the safety and efficacy of combination treatment options with elacestrant, to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes, irrespective of ESR1 mutation status. The study is composed 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 2026 (abstract 1098) include safety and preliminary efficacy data from the phase 1b elacestrant (258-345 mg) plus capivasertib (320-400 mg) cohorts (n=31), which demonstrate preliminary median progression-free survival (mPFS) benefit in the recommended phase 2 dose (RP2D) cohort. The RP2D was determined in cohort 2 (n=9) to be elacestrant 345 mg plus capivasertib 320 mg BID (4 days on/3 days off). In RP2D response-evaluable patients, preliminary efficacy showed an 88.9% disease control rate (DCR), a 66.7% clinical benefit rate at 24 weeks (CBR24), and a 33.3% objective response rate (ORR). All patients with ORR had co-existing ESR1 and PIK3CA mutations. The median duration of response (mDOR) has not yet been reached. The preliminary mPFS was 11.3 months in the overall RP2D population, and 10.9 months in patients with co-existing ESR1 and PIK3CA mutations. Additionally, these initial results show that the combination is consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. “The combination of elacestrant plus capivasertib is designed to address an unmet need for patients with ER+/HER2- PI3K-pathway altered metastatic breast cancer, particularly when co-existing ESR1 and PIK3CA mutations are present.” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute. “These encouraging preliminary data suggest the potential for extended clinical benefit with a manageable safety profile, as the combination regimen could simultaneously target ESR1 and PIK3CA mutations, potentially avoiding the need for sequential regimens that address each target individually.” “Building on the data we saw last year at SABCS, we continue to be encouraged by elacestrant’s potential clinical benefit observed across numerous combinations with different agents targeting ER+/HER2- metastatic breast cancer,” said Elcin Barker Ergun, CEO of the Menarini Group. “The breadth of our studies, including early breast cancer and various combinations for ER+/HER2- metastatic breast cancer, including with capivasertib, demonstrate our commitment to bringing potentially transformational therapies to cancer patients.” In addition, other elacestrant data will be presented at the ASCO congress. See below for a complete list of upcoming presentations: Presentation Title: Elacestrant in combination with capivasertib in patients with ER+/HER2- advanced breast cancer: Update from ELEVATE, a phase 1b/2 open-label, umbrella studyAbstract Number: 1098Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 212Presenting Author: Wassim McHayleh Presentation Title: ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant + everolimus versus elacestrant + placebo in ER+/HER2- advanced breast cancer patients with ESR1-mutated tumors progressing on endocrine therapy + CDK4/6i*#Abstract Number: TPS1154Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 262bPresenting Author: Antonio Llombart-Cussac Presentation Title: ELECTRA: An open-label, multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis from ER+/HER2- breast cancerAbstract Number: TPS1155Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 263aPresenting Author: Nuhad Ibrahim Presentation Title: CAPELA: A phase II multicenter open-label randomized study of capecitabine in combination with elacestrant versus capecitabine alone in advanced estrogen receptor (ER)–positive breast cancer (TBCRC 070)*Abstract Number: TPS1156Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 263bPresenting Author: Kristina Fanucci Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 studyAbstract Number: TPS1153Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 262aPresenting Author: Aditya Bardia *Denotes investigator sponsored research or collaborative research#The ADELA study is a pivotal study co-sponsored with MEDSIR About The Elacestrant Clinical Development ProgramElacestrant 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. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. 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 InformationWarning 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 $5.5 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 GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.com

32 Abstracts and Presentations Showcase Cutting-Edge Research at the 2026 ASCO® Annual Meeting 2026 ASCO® Annual Meeting abstracts featuring FCS research: 1073, 1094, 1530, 2629, 3013, 3078, 3088, 3146, 4213, 5511, 5565, 5580, 6062, 7023, 7029, 7532, 7565, 9564, e13044, e16400, TPS11202, TPS2668, TPS2680, TPS3155, TPS3160, TPS3167, TPS3179, TPS5139, TPS5628, TPS5647, TPS8134, TPS8136 FORT MYERS, Fla., May 28, 2026 /PRNewswire/ -- Findings from 32 abstracts and presentations conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) are among the groundbreaking scientific advances in cancer care that will be featured as oncology professionals from around the world gather this week at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Continue Reading Florida Cancer Specialists & Research Institute (FCS) will present findings from 32 abstracts and presentations at the 2026 ASCO® Annual Meeting, showcasing innovative clinical trials, targeted therapies and precision oncology research led by FCS physicians and researchers across Florida. Thirteen physicians and leaders from the statewide practice will present the outcomes of early and late-phase clinical trials performed at FCS Phase 1 Drug Development Units and clinics throughout Florida. Research conducted at FCS is made possible through valuable relationships with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, Paradigm Health, an AI-enabled clinical trial matching and recruitment platform, and other independent clinical trial programs. FCS Assistant Managing Physician, David Wenk, MD, said, "Our extensive research program is a defining strength of FCS and a vital part of our mission to provide patients with convenient access to world-class cancer care close to home." "The research being presented highlights both innovative treatment strategies and cutting-edge targeted therapies," said FCS Director of Drug Development Manish R. Patel, MD. "Through our ongoing clinical research efforts, we are generating new scientific insights that are advancing precision oncology for patients with a wide range of cancers, including rare and advanced disease." The following FCS principal investigators are first authors on ten abstracts that will be presented throughout the meeting: Lucio Gordan, MD, FCS president & managing physician, Ashley Hernandez, Amanda Warner and Christian Okitondo Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters. Lowell Hart, MD (Retired) (RW) post-progression outcomes after first-line (1L) treatment with ribociclib + an aromatase inhibitor (AI) vs AI alone in US patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC). Maen Hussein, MD, FCS director of value-based care and Kristin Boykin, FCS senior director, pharmacy operations Evaluating the impact of a statewide intervention on multiple myeloma bispecific T-cell engaging antibody (BsAb) therapy uptake in Florida (FL). Management of chemotherapy-induced adverse events in patients with metastatic pancreatic ductal adenocarcinoma: A US-based modified Delphi consensus. Bradley Monk, MD, FACOG, FACS A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Efficacy prediction for progression-free survival (PFS) and overall survival (OS) by genomic instability score (GIS) cutoffs in patients (pts) with advanced ovarian cancer (aOC): Post hoc results from the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial. Manish R. Patel, MD A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results. A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma (ACC) or metastatic castration-resistant prostate cancer (mCRPC). Judy Wang, MD, FCS associate director of drug development, Sarasota Drug Development Unit A first-in-human study of ATX-295, an oral inhibitor of KIF18A, in patients with advanced or metastatic solid tumors, including ovarian cancer. Judy Wang, MD and Cesar Augusto Perez, MD, FCS director of drug development, SCRI at Lake Nona Drug Development Unit Phase 1 dose escalation of CTX-8371, a novel PD-1×PD-L1 bispecific antibody, in patients with advanced malignancies post checkpoint inhibition. The following FCS principal investigators have co-authored 22 additional abstracts and publications of research results and other clinical findings featured throughout the annual meeting: Lucio N. Gordan, MD Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma (LBCL).* Lowell Hart, MD (Retired) (RW) post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) in US. Maen Hussein, MD, FCS medical director, value-based care TIGOS-LS, an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. Bradley Monk, MD TroFuse-036/GOG-3123/ENGOT-cx22: A 2-part, phase 3, randomized study of sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev) vs standard of care (SoC) as first-line maintenance therapy for PD-L1–positive cervical cancer. Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab. Puxitatug samrotecan (AZD8205) vs chemotherapy in patients with B7‑H4–selected advanced/metastatic endometrial cancer: The phase 3 randomized Bluestar‑Endometrial01 (BE01)/GOG-3110/ENGOT-EN28 trial. Manish R. Patel, MD A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results. A randomized, open-label, phase 3 study of ZL-1310, a DLL3 antibody-drug conjugate (ADC), compared to investigator's choice therapy in participants with relapsed small cell lung cancer (DLLEVATE). BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors. Farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) in combination with adagrasib in KRAS G12C mutated (mut) advanced solid tumors: Preliminary results from the FIT-001 phase 1 first-in-human trial. A phase 3 randomized, open-label study of pasritamig (JNJ-78278343), a T-cell engager targeting human kallikrein-2, with docetaxel versus docetaxel for metastatic castration-resistant prostate cancer. Intismeran autogene to induce de novo neoantigen-specific T cells as adjuvant therapy in melanoma. Shachar Peles, MD, FCS director of cell therapy Fixed-duration subcutaneous (SC) mosunetuzumab (Mosun) in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma (DLBCL): Interim analysis and patient-reported outcomes (PROs) from the phase 2 MorningSun study Ivor Percent, MD Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma. Cesar Augusto Perez, MD First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion. BMS-986504 in patients (pts) with advanced solid tumors with homozygous MTAP deletion (MTAP-del): Exploratory pharmacodynamic (PD) and biomarker analyses from CA240-0007. A phase 1/2, first-in-human, open-label, dose-escalation and -expansion study of TAK-188, a novel antibody-drug conjugate (ADC) targeting CCR8+ regulatory T cells, in adult patients with locally advanced or metastatic solid tumors. A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. First-in-human phase 1a/1b study of LB-LR1109, an anti-LILRB1 monoclonal antibody, as monotherapy in advanced solid tumors and in combination with atezolizumab in advanced NSCLC. Judy Wang, MD A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay (NMD) inhibitor in patients with advanced/metastatic solid tumors (parts 1 and 2). Syed Zafar, MD Durable clinical benefit with B-cell maturation antigen (BCMA)–directed therapy, belantamab mafodotin plus pomalidomide and dexamethasone (BPd) in relapsed/refractory multiple myeloma (RRMM): DREAMM‑8 long‑term responder (LTR) analysis. FCS Chief Executive Officer Ryan Ciarrocchi said, "The ASCO® Annual Meeting highlights the most significant cancer research from around the world, and FCS is proud to once again be recognized among the leaders helping to shape the future of cancer care." All abstracts and presentations are available to view at ASCO® 2026 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. About Florida Cancer Specialists & Research Institute, LLC: ( FLCancer.com ) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo