A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.

开始日期2025-04-01

申办/合作机构

Yale University

[+2]

NCT06201234

/ Recruiting临床2期

Phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients with Hormone Receptor (HR)-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer with GBRCA1/2 Mutations

Trial design:
Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.
Trial population:
Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of > 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications.
Interventions:
Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression/end of study.

开始日期2024-12-13

申办/合作机构

GBG Forschungs GmbH

[+1]

NCT06382948

/ Recruiting临床3期

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.
The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

开始日期2024-12-05

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

100 项与艾拉司群相关的临床结果

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100 项与艾拉司群相关的专利（医药）

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103

项与艾拉司群相关的文献（医药）

2025-05-01·Molecular Diagnosis & Therapy

Clinical Actionability of Molecular Targets in Multi-Ethnic Breast Cancer Patients: A Retrospective Single-Institutional Study

Article

作者: Naghi, Leah ; Mortimer, Joanne ; Yost, Susan E ; Kang, Irene

BACKGROUND:

Precision oncology is making remarkable advancements in optimizing patient care by personalizing treatments. To date, the US Food and Drug Administration (FDA) has approved poly(ADP-ribose) polymerase inhibitors (PARPi) olaparib (Lynparza, AstraZeneca and Merck) and talazoparib (Talzenna, Pfizer Oncology Together™) for germline or somatic BRCA1/2-mutated metastatic breast cancer (BC) patients, and PI3K inhibitor alpelisib (Piqray, Novartis) plus fulvestrant for patients with hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2-) PIK3CA-mutated advanced BC. In addition, the FDA approved capivasertib (Trucap, AstraZeneca) for HR+HER2- locally advanced or metastatic BC patients with one or more AKT1, PIK3CA, or PTEN alterations. Finally, the FDA recently approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal patients with ER+ HER2- ESR1-mutated advanced or metastatic BC with disease progression following at least one line of endocrine therapy.

METHODS:

This study presents a single institutional retrospective review of genomic reports of patients with BC. Analysis of genomic reports of 1361 BC sequencing reports was performed for 1010 patients with BC from 2013 to 2023 (23% of patients had multiple reports). Eligible patients had at least one primary or metastatic tumor. Multiple sequencing platforms were used for FFPE specimens including Tempus xT targeted next-generation sequencing (NGS), Foundation One Medicine, HopeSeq, Ashion Analytics GEM ExTra, and Exact Sciences Oncomap. Liquid biopsies were performed by Guardant, Tempus, and Foundation One Medicine. Chart reviews were performed to collect patient characteristics. BRCA1/2-mutated, metastatic BC patients who initiated treatment with olaparib or talazoparib, and PIK3CA-mutated, HR+ metastatic BC patients who initiated treatment with alpelisib were reported. In addition, patients with ESR1 or AKT1/PIK3CA/PTEN mutations were identified. Clinical outcomes, including progression-free survival (PFS) and overall survival (OS) were analyzed for BRCA1/2 and PIK3CA-mutated patients who received PARPi or alpelisib. Survival curves were generated using the Kaplan Meier method.

RESULTS:

A cohort of 1010 BC patients with 1361 genomic reports was identified. A total of 935/1361 (69%) specimens were formalin-fixed paraffin-embedded (FFPE) tumor biopsies and 426/1361 (31%) were liquid biopsies. Receptor status included 65% HR+HER2-, 8% HR+HER2+, 4% HR-HER2+, and 23% TNBC. Racial and ethnic distribution of these patients included 50% non-Hispanic White, 26% Hispanic, 17% Asian, 6% African American, 1% other (Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, or unknown). Sequencing platforms included 30% Tempus xT, 31% Foundation One, 10% HopeSeq, 20% GEM ExTra, and 9% Exact Sciences. Liquid biopsies included 79% Guardant, 20% Tempus, and 1% Foundation One. Of 1010 patients, the most common mutations were TP53 (44%), PIK3CA (38%), ESR1 (14%), PTEN (12%), CCND1 (11%), FGFR1 (10%), CDH1 (10%), ERBB2 (9%), MYC (9%), FGF3 (8%), GATA3 (8%), FGF19 (8%), FGF4 (7%), ARID1A (6%), RB1 (5%), BRCA2 (5%), MAP3K1 (4%), AKT1 (4%), NF1 (4%), MLL3 (4%), ZNF703 (4%), CDKN2A (4%), BRCA1 (4%), MCL1 (3%), ATM (3%), PALB2 (1%), and CHEK2 (1%). The majority of reports with tumor mutation burden (TMB) results (97%) had low or intermediate TMB. A total of 784 actionable mutations in 1010 patients were reported, including 381/1010 (38%) PIK3CA; 144/1010 (14%) ESR1; 122/1010 (12%) PTEN; 48/1010 (5%) BRCA2; 36/1010 (4%) BRCA1; 41/1010 (4%) AKT1; and 12/1010 (1%) PALB2. Of the 96/1010 (10%) patients with BRCA1, BRCA2, or PALB2 mutations not including variants of uncertain significance (VUS), 33/96 (34.4%) received olaparib and 3/96 (3%) received talazoparib in the metastatic setting, and 28 were eligible for response (one had toxicity, two were lost to follow-up, and two went to hospice). Median PFS was 9.0 months and median OS was 21.8 months for patients receiving PARPi. Of the 381/1010 (38%) patients with PIK3CA mutations, 84/381 (22%) received alpelisib and 41 were eligible for response (22 had toxicity, 13 were discontinued, six were lost to follow-up, and two went to hospice). Median PFS was 7.9 months and median OS was 31.2 months for patients receiving alpelisib. A total of 544/1010 (54%) patients had AKT1, PIK3CA, or PTEN mutations which are now FDA approved for capivasertib in HR+HER2- metastatic BC patients. In addition, 144/1010 (14%) patients had ESR1 mutations which are FDA approved for elacestrant in HR+HER2- metastatic BC patients.

CONCLUSIONS:

In this study, a total of 784 clinically actionable mutations were reported for 1010 patients with genomic sequencing. Of these, 96/1010 (10%) patients had at least one actionable mutation in homologous recombination repair genes (BRCA1, BRCA2, PALB2) and 36/96 (37.5%) patients received PARP inhibitors (33 olaparib and three talazoparib). In addition, 381/1010 (38%) patients had at least one clinically actionable PIK3CA mutation, and 84/381 (22%) received alpelisib. Additionally, 544/1010 (54%) of patients had either AKT1 (41/1010), PIK3CA (381/1010), or PTEN (122/1010) alterations that were FDA approved in November 2023 for capivasertib in the treatment of HR+HER2- metastatic BC (MBC) patients. Furthermore, 144/1010 (14%) patients in this study had at least one ESR1 mutation, a clinically actionable mutation that was FDA approved in January 2023 for elacestrant in the treatment of ER+HER2- MBC patients (44% detected by liquid biopsy). Future studies are needed to determine the efficacy of elacestrant and capivasertib for patients with these mutations, and to tailor strategies for optimal patient quality of life and cancer outcome.

2025-04-01·CANCER TREATMENT REVIEWS

Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer

Review

作者: Sahin, Taha Koray ; Aksoy, Sercan ; Guven, Deniz Can ; Rizzo, Alessandro

The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) is the standard first-line treatment for hormone receptor-positive (HR + ) and HER2-negative metastatic breast cancer (mBC). Despite their efficacy, resistance inevitably develops, necessitating alternative therapeutic strategies post-progression. This review explores current and emerging treatment options following progression on CDK4/6i, focusing on endocrine therapies, targeted therapies, combination approaches, and the continued use of CDK4/6i. Endocrine therapies, including fulvestrant and novel oral selective estrogen receptor degraders (SERDs) like elacestrant, show promise, especially in patients with ESR1 mutations. Targeted therapies such as PI3K/AKT/mTOR inhibitors, exemplified by alpelisib and capivasertib, offer potential by addressing downstream signaling pathways involved in resistance. Additionally, FGFR inhibitors like erdafitinib are under investigation for their role in overcoming specific resistance mechanisms. Combination strategies involving CDK4/6 inhibitors with immune checkpoint inhibitors or other targeted agents are also being explored, with early trials suggesting possible synergistic effects, although further validation is required. Continuation of CDK4/6 inhibitors beyond progression has shown potential benefits in selected patients, but the data are heterogeneous, and further studies are needed to clarify their role. While chemotherapy remains a standard option for patients who progress on these treatments, the goal is to delay its use through the effective utilization of endocrine and targeted therapies. Understanding resistance mechanisms and tailoring treatment to individual patient profiles is crucial for optimizing outcomes. Ongoing clinical trials are expected to provide deeper insights, guiding the development of more effective post-progression therapeutic strategies. This evolving landscape highlights the need for continuous research and individualized patient care to improve survival and quality of life in HR + mBC patients.

2025-04-01·CLINICAL CANCER RESEARCH

Elacestrant in Women with Estrogen Receptor–Positive and HER2-Negative Early Breast Cancer: Results from the Preoperative Window-of-Opportunity ELIPSE Trial

Article

作者: Bellet, Meritxell ; Cortadellas, Tomás ; Gonzalez-Farré, Xavier ; Muñoz-Mateu, Montserrat ; Falato, Claudette ; Siso, Christian ; Pascual, Tomás ; Amillano, Kepa ; Bergamino, Milana A. ; Luna, Miguel A. ; Espinosa Guerrero, Alejandra ; Salvador, Fernando ; Cebrecos, Isaac ; Galván, Patricia ; Ferrero-Cafiero, Juan M. ; Sanfeliu, Esther ; Prat, Aleix ; Margelí Vila, Mireia ; Sanchez-Bayona, Rodrigo ; Vidal, Maria ; Pare, Laia

Abstract:

Purpose::

Elacestrant has shown significantly prolonged progression-free survival compared with standard-of-care endocrine therapy in estrogen receptor–positive (ER-positive), HER2-negative metastatic breast cancer, whereas potential benefit in early-stage disease requires further exploration. The SOLTI-ELIPSE window-of-opportunity trial investigated the biological changes induced by a short course of preoperative elacestrant in postmenopausal women with early breast cancer.

Patients and Methods::

Eligible patients with untreated T1c (≥1.5 cm)-T3, N0, ER-positive/HER2-negative breast cancer with locally assessed Ki67 ≥10% received elacestrant at a daily dose of 345 mg for 4 weeks. The primary efficacy endpoint was complete cell cycle arrest, defined as Ki67 ≤2.7%, on day 28.

Results::

Overall, 22 patients were evaluable for the primary endpoint. Elacestrant was associated with a complete cell cycle arrest rate of 27.3% and a statistically significant Ki67 geometric mean change of −52.9% (P = 0.007; 95% confidence interval, −67.4 to −32.1). Notably, the treatment with elacestrant led to a shift toward a more endocrine-sensitive and less proliferative tumor phenotype based on PAM50-based gene signatures. Elacestrant increased the expression of immune-response genes (GZMB, CD4, and CD8A) and suppressed proliferation and estrogen-signaling genes (MKI67, ESR1, and AR). These biological changes were independent of the levels of Ki67 suppression on day 28. The most common adverse events were grade 1 anemia (21.7%), hot flushes (8.7%), constipation (8.7%), and abdominal pain (8.7%). One patient experienced a grade 3 cutaneous rash, leading to treatment discontinuation. No other serious adverse events were reported.

Conclusions::

Preoperative treatment with elacestrant in early breast cancer demonstrated relevant biological and molecular responses and exhibited a manageable safety profile. These findings support further investigation of elacestrant in the early setting.

217

项与艾拉司群相关的新闻（医药）

2025-05-22

·EINPresswire

Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting

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. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果ASCO会议临床2期临床3期

2025-05-20

·氨基观察

靖因药业长效Factor XI疗法对外授权；艾加莫德皮下注射治疗CIDP的中国亚组数据公布

氨基观察-创新药组原创出品作者 | 黄恺国产分子持续出海。5月20日，靖因药业宣布，与CRISPR Therapeutics宣布双方达成战略合作伙伴关系，共同开发并商业化下一代长效Factor XI（FXI）靶向小干扰RNA（siRNA）疗法SRSD107，用于治疗血栓及血栓栓塞性疾病。再鼎医药艾加莫德皮下注射治疗CIDP的中国亚组数据公布。5月19日，在英国爱丁堡举行的国际周围神经病学会（PNS）年会上，ADHERE研究中国亚组数据以海报形式公布。研究结果显示，艾加莫德皮下注射在中国慢性炎性脱髓鞘性多发性神经根神经病（CIDP）患者中展现出具有临床意义的有效性，中国入组患者在阶段A的应答率达77.6%，而全球亚组为66%。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）靖因药业长效Factor XI小干扰RNA疗法对外授权5月20日，靖因药业宣布，与CRISPR Therapeutics宣布双方达成战略合作伙伴关系，共同开发并商业化下一代长效Factor XI（FXI）靶向小干扰RNA（siRNA）疗法SRSD107，用于治疗血栓及血栓栓塞性疾病。2）超60亿美元！三生制药PD-1/VEGF双抗授权辉瑞5月20日，三生制药发布公告，公司及附属子公司沈阳三生、三生国健与辉瑞签署协议，向辉瑞独家授予突破性PD-1/VEGF双特异性抗体SSGJ-707在全球（不包括中国大陆）的开发、生产、商业化权利。根据协议，三生制药将获得12.5亿美元不可退还且不可抵扣的首付款，以及最高可达48亿美元的开发、监管批准和销售里程碑付款。公司还将根据授权地区的产品销售额收取两位数百分比的梯度销售分成。同时，辉瑞还将于协议生效日认购三生制药价值1亿美元的普通股股份。/ 02 /资本信息1）柯君医药完成超亿元B+轮融资5月20日，上海柯君医药宣布完成全部超亿元规模B+轮融资，所得资金将主要用于推进心脑血管领域核心产品CG-0255的三期临床开发。/ 03 /医药动态1）艾加莫德皮下注射治疗CIDP的ADHERE研究中国亚组数据公布5月19日，在英国爱丁堡举行的国际周围神经病学会（PNS）年会上，ADHERE研究中国亚组数据以海报形式公布。研究结果显示，艾加莫德皮下注射在中国慢性炎性脱髓鞘性多发性神经根神经病（CIDP）患者中展现出具有临床意义的有效性，中国入组患者在阶段A的应答率达77.6%，而全球亚组为66%。2）口服SERD新药Elacestrant在中国的III期桥接临床试验完成首例受试者入组给药5与20日，金赛药业宣布，全球首款口服选择性雌激素受体降解剂（SERD）药物elacestrant（艾拉司群）在中国开展的III期桥接临床试验取得重要进展——复旦大学附属肿瘤医院邵志敏教授团队已于近日成功完成首例受试者入组给药。/ 04 /数字医疗日报1）镁信健康创始人兼CEO张小栋：未来聚焦三大方向5月20日，在镁信健康举办的生态合作大会上，公司创始人兼首席执行官张小栋表示，未来镁信健康将聚焦“商业健康险更广覆盖、创新药械多元支付新基建以及医药支付生态”三大方向。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

引进/卖出临床3期突破性疗法siRNA

2025-05-15

·carricktherapeutics.com

Carrick Therapeutics Announces New Clinical Data Supporting Biomarker-driven Patient Selection for Samuraciclib (CDK7i) in Combination with SERDs in Hormone Receptor Positive Advanced Breast Cancer

Two independent Phase 2 trials demonstrate extended progression-free survival in patients without TP53 mutations or without liver metastases Results presented at 2025 ESMO Breast Cancer Annual Congress BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Carrick Therapeutics Inc., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced results from a new analysis of two Phase 2 clinical trials of samuraciclib, a novel investigational oral and first-in-class inhibitor of CDK7, in patients with hormone receptor positive (HR+) advanced breast cancer who had received prior CDK4/6 inhibitor therapy. The MORPHEUS trial evaluated samuraciclib in combination with giredestrant and the Module 2A trial evaluated samuraciclib in combination with fulvestrant. The analysis indicated that study participants with no evidence of a deleterious mutation in the TP53 gene in circulating tumor DNA at baseline or separately, without liver metastases at baseline, experienced extended durations of progression-free survival. This further supports the Company’s biomarker-driven patient selection strategy. Results of the data analysis were presented in a poster session at the 2025 ESMO Breast Cancer Annual Congress held in Munich, Germany. "Based on the results from these two independent studies, we have identified patient populations showing improved progression-free survival, highlighting the potential of samuraciclib in combination with SERDs as an effective new treatment option for these patients. Carrick is further validating these two selection strategies in two additional Phase 2 studies reading out later this year with the intent to advance to Phase 3 in 2026, enriching for one of these two patient groups,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. Results of the data analysis indicated improved progression-free survival both for patients with no TP53 mutation, compared to those with mutation, and also for patients without liver metastases, compared to those with liver metastases. “Patients with HR positive, HER2 negative advanced breast cancer are typically treated with a CDK4/6 inhibitor in combination with an endocrine therapy, but unfortunately almost all patients eventually develop resistance to therapy,” said Dr. Stuart McIntosh, Chief Medical Officer of Carrick Therapeutics. “Those patients are in need of effective new targeted therapies that are durable and tolerable in combination with endocrine therapy, including oral SERDs. These results from two independent trials of samuraciclib in combination with a SERD are very encouraging.” Carrick is further evaluating its patient-selection strategy in two ongoing Phase 2 clinical trials. In collaboration with the Menarini Group, Carrick is executing the SUMIT-ELA trial evaluating the efficacy and safety of samuraciclib in combination with the oral SERD elacestrant in patients with HR+, human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer who were previously treated with a CDK4/6 inhibitor and aromatase therapy. The randomized SUMIT-BC trial is evaluating the efficacy and safety of samuraciclib in combination with fulvestrant vs. fulvestrant alone in patients with HR+, HER2- locally advanced or metastatic breast cancer who were previously treated with a CDK4/6 inhibitor and aromatase therapy. With the results of the multi-center international SUMIT studies, Carrick will have studied CDK7i plus SERD combination therapy in over 150 patients. About Samuraciclib (CT7001) Samuraciclib is the most advanced cyclin dependent kinase 7 (CDK7) inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer, as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression, and promotes resistance to anti-hormone therapy. Samuraciclib, an oral CDK7 inhibitor, has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in HR+ breast cancer. Because of its ability to inhibit CDK7, samuraciclib has the potential to treat prostate, pancreatic, small cell lung cancer, triple negative breast (TNBC), ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer. About Carrick Therapeutics Carrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel oral first-in-class inhibitor of CDK7 currently in multiple Phase 2 clinical trials for metastatic HR+ breast cancer. The Company is collaborating with Roche and Menarini Group to evaluate novel combinations of samuraciclib with oral SERD endocrine therapies. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is currently in a Phase 1 clinical trial. For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com Carrick Contacts Carrick Therapeutics Jenny Horsfield, Chief Business Officer jenny.horsfield@carricktherapeutics.com Investors and Media Luke Heagle, Real Chemistry lheagle@realchemistry.com Released May 15, 2025

临床2期快速通道临床结果临床1期

100 项与艾拉司群相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11671	艾拉司群	-	DB06374

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
转移性乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
ER阳性/HER2阴性/ESR1突变乳腺癌	美国	Stemline Therapeutics, Inc.	2023-01-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	申请上市	美国	Radius Pharmaceuticals, Inc.	2022-06-22
淋巴结阳性乳腺癌	临床3期	美国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	澳大利亚	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	奥地利	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	加拿大	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	捷克	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	法国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	德国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	匈牙利	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	意大利	Stemline Therapeutics, Inc.	2024-09-27

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03778931 (EMERALD, ESMO_BC2025)	临床3期	转移性乳腺癌 ESR1	966	elacestrant (ESR1 mutation testing by liquid biopsy using ddPCR)	積顧鑰選鑰衊繭夢窪膚(簾憲艱簾簾網齋糧鑰選) = 獵繭淵廠繭艱齋製醖膚鑰壓餘網醖淵襯醖艱窪 (願鏇膚築壓糧襯醖網膚, 33.2% ~ 39.4) 更多	积极	2025-05-14
NCT06492616 (ELEGANT, AACR2025)	临床3期	淋巴结阳性乳腺癌 \| ER阳性乳腺癌 ESR1	-	Elacestrant	襯淵膚選夢廠願鬱蓋鏇(築網繭範壓網鏇衊壓網): HR = 0.7 (95% CI, 0.55 ~ 0.88), P-Value = 0.0018	积极	2025-04-29
				Standard Endocrine Therapy (AI or tamoxifen)
SABCS2024 人工标引	N/A	ER阳性/HER2阴性乳腺癌 HER2 Negative	212	Elacestrant	繭餘襯蓋築鏇簾襯夢鏇(糧鬱蓋齋蓋醖鏇壓餘襯) = 夢願觸壓積構構襯淵鏇獵憲壓襯繭獵糧衊獵繭 (齋醖糧夢夢積範淵蓋鹽, 5.4 ~ NR)	积极	2024-12-10
				Elacestrant (1-2 lines of prior ET)	繭餘襯蓋築鏇簾襯夢鏇(糧鬱蓋齋蓋醖鏇壓餘襯) = 蓋鹽蓋願築鏇餘鑰餘蓋獵憲壓襯繭獵糧衊獵繭 (齋醖糧夢夢積範淵蓋鹽, 4.9 ~ NR)
NCT05563220 \| NCT05386108 (ELEVATE, SABCS2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	55	Elacestrant + Abemaciclib (all efficacy-evaluable)	夢糧壓糧範顧衊遞簾餘(鑰齋製膚衊築製網夢齋) = 遞鬱構鏇積膚鬱憲醖齋餘膚觸繭夢顧繭蓋製願 (衊鏇廠積夢蓋築選繭獵 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	夢糧壓糧範顧衊遞簾餘(鑰齋製膚衊築製網夢齋) = 觸遞簾齋構獵醖窪鹹糧餘膚觸繭夢顧繭蓋製願 (衊鏇廠積夢蓋築選繭獵 )
NCT05563220 (ELEVATE, ESMO2024)	临床1/2期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-negative \| ESR1-mut	-	Elacestrant + Everolimus	衊積範網憲衊壓獵製糧(衊簾齋膚醖鏇選鹽網網) = 10 (43) 2 (9) 製鏇衊壓獵夢範鹹鹹繭 (選鹹艱範襯糧窪憲築積 ) 更多	积极	2024-09-16
				Elacestrant + Palbociclib
NCT05386108 (ELECTRA, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌二线 ER Positive \| HER2 Negative \| ESR1 Mutation	26	Elacestrant + Abemaciclib	積繭襯製艱憲餘壓憲廠(艱積鑰襯膚蓋鹹選範壓) = 糧製憲壓壓網糧淵顧顧鬱襯構築蓋壓顧糧艱簾 (選遞製網獵襯襯鏇鹽積 ) 更多	积极	2024-05-24
NCT05563220 (ELEVATE, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Positive	20	Elacestrant + Ribociclibribociclib	襯繭夢憲鹽觸淵鬱憲積(選鏇膚鏇壓醖齋鏇淵鏇) = Most common (≥30%) all-grade (Gr) AEs were decreased neutrophils/neutropenia (n=6, 50%; Gr3+ n=4, 33%) in the elacestrant (86-172 mg) + ribociclib (400 mg) cohorts 鏇鹹製範製壓壓糧憲齋 (遞願鏇窪壓膚糧窪膚繭 ) 更多	积极	2024-05-24
				elacestrantelacestrant (258-345 mg) + palbociclib (100 mg) cohorts
EMERALD study (ASCO2024)	N/A	HR阳性/HER2阴性乳腺癌 ESR1-mutant	418	Elacestrant	鬱鑰廠網觸願窪獵觸鏇(蓋簾鑰鹽廠廠鹹壓醖淵) = 夢糧鬱鏇蓋觸憲觸憲膚簾襯範顧構膚餘蓋鏇願 (廠鹹鑰顧網窪艱衊構壓, 4.2 ~ not reached [NR]) 更多	积极	2024-05-24
NCT05386108 (ELECTRA, AACR2024)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Abemaciclib	艱製觸糧鏇觸願蓋遞觸(範憲獵蓋衊鏇積構顧鹹) = 醖鑰廠醖憲鑰膚鹽製窪衊選衊餘觸顧網選鹹願 (廠獵壓鬱壓蓋淵築窪鹹 )	-	2024-04-05
NCT03778931 (EMERALD, Pubmed \| J Clin Oncol)	临床3期	ER阳性/HER2阴性乳腺癌	478	Elacestrant 345 mg	襯膚憲醖鏇餘襯夢觸簾(遞鏇繭淵觸積壓鬱窪餘) = More patients who received elacestrant experienced dyslipidemia 糧襯鹽蓋襯窪齋淵遞餘 (觸構窪鹹鏇衊遞廠糧齋 ) 更多	积极	2024-04-01
				Investigator's choice of ET