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美纳里尼集团在2024年圣安东尼奥癌症乳腺癌研讨会上展示了新的和扩展的数据,加强了ORSERDU®(Elacestrent)对ER+、HER2-晚期或转移性癌症(mBC)患者的作用

Menarini Group Presents New and Expanded Data at the 2024 San Antonio Breast Cancer Symposium Reinforcing the Role of ORSERDU ® (Elacestrant) for Patients with ER+, HER2- Advanced or Metastatic Breast Cancer (mBC)

businesswire 等信源发布 2024-11-26 06:24

可切换为仅中文


FLORENCE, Italy & NEW YORK--(BUSINESS WIRE)--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 new and expanded data on ORSERDU® (elacestrant) at the upcoming 2024 San Antonio Breast Cancer Symposium (SABCS), December 10-13, 2024.

意大利佛罗伦萨和纽约——(商业新闻短讯)——领先的国际制药和诊断公司美纳里尼集团(“美纳里尼”)和美纳里尼集团全资子公司斯特姆林治疗公司(“斯特姆林”)将于2024年12月10日至13日在即将举行的2024年圣安东尼奥乳腺癌研讨会(SABCS)上提供有关ORSERDU®(elacestrant)的新数据和扩展数据。

Of note, the company will bring real-world progression-free survival (rwPFS) results of ORSERDU in adult patients with ER+/HER2-, advanced or metastatic breast cancer (mBC). Additionally, the company will present updated efficacy results of elacestrant plus abemaciclib, along with a pooled safety analysis from phase 1b/2 of both the ELECTRA and ELEVATE trials..

值得注意的是,该公司将为ER+/HER2-,晚期或转移性乳腺癌(mBC)的成年患者带来ORSERDU的现实世界无进展生存期(rwPFS)结果。此外,该公司将提供elacestrant加abemaciclib的最新疗效结果,以及ELECTRA和ELEVATE试验1b/2期的汇总安全性分析。。

ORSERDU Real-World Progression-Free Survival Data

ORSERDU is the first and only oral estrogen receptor antagonist (SERD) approved to target ESR1-mutated tumors, which occur in up to 50% of ER+, HER2- advanced or mBC tumors, as a result of prior exposure to endocrine therapy (ET) in the metastatic setting. Since its approval by the U.S. Food & Drug Administration (FDA) in January 2023, sufficient time has passed to be able to characterize the real-world use of ORSERDU in the current mBC treatment landscape..

ORSERDU是第一种也是唯一一种被批准用于靶向ESR1突变肿瘤的口服雌激素受体拮抗剂(SERD),由于先前暴露于内分泌治疗(ET),ESR1突变肿瘤发生在高达50%的ER+,HER2晚期或mBC肿瘤中转移设置。自2023年1月获得美国食品和药物管理局(FDA)批准以来,已经有足够的时间来描述ORSERDU在当前mBC治疗领域的实际使用情况。。

Results to be reported at SABCS 2024 show the efficacy of ORSERDU in the real-world setting in patients with ER+/HER2- advanced or mBC. The overall population analysis demonstrated median rwPFS of 6.8 months. Median rwPFS for patients with 1-2 lines of prior ET in mBC was 8 months. The rwPFS observed is consistent across the subgroups in the analysis.

。总体人口分析显示rwPFS中位数为6.8个月。mBC中有1-2行先前ET的患者的中位rwPFS为8个月。在分析中,观察到的rwPFS在各个亚组之间是一致的。

Updated results and additional information from other patient subgroups will be presented at the congress..

来自其他患者亚组的最新结果和其他信息将在大会上介绍。。

The full abstract (SESS-1876) can be viewed here (page 1748).

完整摘要(SESS-1876)可以在这里查看(第1748页)。

“These exciting data show clinically meaningful real-world progression-free survival with ORSERDU monotherapy,” said Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of medicine, UT Health San Antonio, MD Anderson Cancer Center. “As a practicing physician, these results underscore the need to test patients’ tumors for the ESR1 mutation at each disease progression using liquid biopsy, so that we can appropriately tailor their treatment and optimize their care.”.

“这些令人兴奋的数据显示,ORSERDU单药治疗具有临床意义的现实世界无进展生存期,”弗吉尼亚·卡克拉马尼(Virginia Kaklamani)说,她是医学博士,DSc,乳腺肿瘤学家和医学教授,UT Health San Antonio,MD安德森癌症中心。“作为执业医师,这些结果强调需要使用液体活检在每种疾病进展时测试患者肿瘤的ESR1突变,以便我们可以适当调整他们的治疗并优化他们的护理。”。

Elacestrant Plus Abemaciclib Combination Study

Both the ELEVATE and ELECTRA phase 1b/2 studies were designed with the objective to evaluate patient outcomes through combination treatment options, by overcoming a tumor’s resistance to ET.

Results to be reported at SABCS 2024 include updated efficacy results from the ELECTRA study which demonstrate favorable progression-free survival (PFS) data. In all efficacy-evaluable patients, median progression-free survival (mPFS) was 8.6 months. In patients with an ESR1 mutation, mPFS was 8.7 months.

SABCS 2024报告的结果包括ELECTRA研究的最新疗效结果,该研究显示了有利的无进展生存期(PFS)数据。在所有可评估疗效的患者中,中位无进展生存期(mPFS)为8.6个月。在ESR1突变的患者中,mPFS为8.7个月。

In patients without an ESR1 mutation, mPFS was 7.2 months..

在没有ESR1突变的患者中,mPFS为7.2个月。。

Additionally, a pooled safety analysis of patients from ELECTRA and ELEVATE show a manageable and predictable safety profile in patients with ER+/HER2- mBC that is treated with elacestrant plus abemaciclib, and who previously received one or more lines of prior therapy. Safety was evaluated in all patients who received this combination and was consistent with the known safety profiles of both compounds.

此外,对来自ELECTRA和ELEVATE的患者进行的汇总安全性分析显示,接受elacestrant加abemaciclib治疗的ER+/HER2-mBC患者以及之前接受过一种或多种治疗的患者具有可控且可预测的安全性。在所有接受这种组合的患者中评估了安全性,并且与两种化合物的已知安全性特征一致。

The most common all-grade adverse events (AEs) (≥20%) were diarrhea, nausea, neutropenia, vomiting, fatigue, anemia and decreased appetite. No Grade 4 AEs were observed..

最常见的所有级别不良事件(AE)(≥20%)是腹泻,恶心,中性粒细胞减少,呕吐,疲劳,贫血和食欲下降。没有观察到4级AE。。

The full abstract (SESS-1910) can be viewed here (page 3330).

完整摘要(SESS-1910)可以在这里查看(第3330页)。

“These updated results on the combination of elacestrant plus abemaciclib continue to show encouraging progression-free survival data, and a favorable safety profile, without any new toxicity signals when using these agents in combination,” said Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Endowed Professor in Breast Cancer, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco.

“这些关于elacestrant联合abemaciclib的最新结果继续显示出令人鼓舞的无进展生存数据和良好的安全性,当联合使用这些药物时没有任何新的毒性信号,”医学博士Hope S.Rugo说,医学教授和Winterhof Family Endowed乳腺癌教授,加利福尼亚大学旧金山分校乳腺肿瘤学和临床试验教育主任。

“Elacestrant continues to show potential to become an endocrine therapy backbone for combination regimens in metastatic breast cancer, and we are excited to explore this treatment combination further as these trials move forward.”.

“Elacestrant继续显示出成为转移性乳腺癌联合治疗方案内分泌治疗骨干的潜力,随着这些试验的进展,我们很高兴能进一步探索这种治疗组合。”。

“It is exciting to see these progression-free survival outcomes in a real-world setting, which shows ORSERDU brings a meaningful benefit for oncologists to offer their patients,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are committed to advancing our robust clinical research program on elacestrant and unlocking its full potential, both in monotherapy and combination treatment settings, with the goal of bringing ORSERDU to new patient populations which may benefit.”.

美纳里尼集团首席执行官埃尔辛·巴克·埃尔根(ElcinBarker Ergun)说:“在现实世界中看到这些无进展生存结果令人兴奋,这表明ORSERDU为肿瘤学家为患者提供了有意义的益处。”。“我们致力于推进elacestrant强大的临床研究计划,并在单一疗法和联合治疗环境中充分发挥其潜力,目标是将ORSERDU带给可能受益的新患者群体。”。

Menarini Stemline will also share results of other relevant data from the Phase 3 EMERALD trial, as well as several trials in progress.

梅纳里尼·斯特姆林(MenariniStemline)还将分享第三阶段祖母绿试验的其他相关数据以及正在进行的几项试验的结果。

Complete List of Menarini Stemline Abstracts:

梅纳里尼·斯特姆林摘要完整列表:

Title: Elacestrant real-world progression-free survival (rwPFS) of adult patients with ER+/HER2-, advanced breast cancer: a retrospective analysis using insurance claims in the United States

标题:成年ER+/HER2晚期乳腺癌患者的Elacestrant现实世界无进展生存期(rwPFS):使用美国保险索赔的回顾性分析

Poster Number: P3-10-08

海报编号:P3-10-08

Date & Time: Thursday, December 12, 12-2 PM CST

Date & Time: Thursday, December 12, 12-2 PM CST

Location: TBC

地点:待定

Presenting Author: Elyse Swallow

Title: Elacestrant plus abemaciclib (abema) combination in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer (mBC)

标题:Elacestrant联合abemaciclib(abema)治疗雌激素受体阳性(ER+),HER2阴性(HER2-)晚期或转移性乳腺癌(mBC)患者

Poster Number: PS7-07

海报编号:PS7-07

Date & Time: Thursday, December 12, 7-8:30 AM CST

Date & Time: Thursday, December 12, 7-8:30 AM CST

Location: TBC

地点:待定

Presenting Author: Hope Rugo

演示作者:Hope Rugo

Title: Elacestrant combination in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase 1b/2, open-label, umbrella study

标题:雌激素受体阳性(ER+),HER2阴性(HER2-)局部晚期或转移性乳腺癌(mBC)患者的Elacestrant联合治疗:来自ELEVATE的更新,1b/2期,开放标签,伞式研究

Poster Number: PS7-06

海报编号:PS7-06

Date & Time: Thursday, December 12, 7-8:30 AM CST

Date & Time: Thursday, December 12, 7-8:30 AM CST

Location: TBC

地点:待定

Presenting Author: Hope Rugo

演示作者:Hope Rugo

Title: Elacestrant vs SOC in ER+, HER2- advanced or metastatic breast cancer (mBC) with ESR1-mutated tumors: ESR1 allelic frequencies and clinical activity from the phase 3 EMERALD trial

标题:具有ESR1突变肿瘤的ER+,HER2晚期或转移性乳腺癌(mBC)中的Elacestrant与SOC:3期EMERALD试验的ESR1等位基因频率和临床活性

Poster Number: P1-01-25

海报编号:P1-01-25

Date & Time: Wednesday, December 11, 12-2 PM CST

Date & Time: Wednesday, December 11, 12-2 PM CST

Location: TBC

地点:待定

Presenting Author: Aditya Bardia

演示作者:Aditya Bardia

Title: ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study

标题:优雅:在一项全球性,多中心,随机,开放标签的3期研究中,Elacestrant与标准内分泌治疗在淋巴结阳性,雌激素受体阳性,HER2阴性,复发风险高的早期乳腺癌患者中的比较

Poster Number: P2-08-21

海报编号:P2-08-21

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Location: TBC

地点:待定

Presenting Author: Aditya Bardia

演示作者:Aditya Bardia

Title: ADELA: A randomized, phase 3, double-blind, placebo-controlled trial of elacestrant plus everolimus versus elacestrant in ER+/HER2-advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) plus CDK4/6i

标题:ADELA:elacestrant加依维莫司与elacestrant在ER+/HER2晚期乳腺癌(aBC)患者中进行的一项随机,3期,双盲,安慰剂对照试验,这些患者的ESR1突变肿瘤在内分泌治疗(ET)加CDK4/6i上进展

Poster Number: P2-10-21

海报编号:P2-10-21

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Location: TBC

地点:待定

Presenting Author: Antonio Llombart-Cussac

演示作者:安东尼奥·伦巴特·库萨克

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

Poster Number: P2-08-20

海报编号:P2-08-20

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Date & Time: Wednesday, December 11, 5:30-7:30 PM CST

Location: TBC

地点:待定

Presenting Author: Virginia Kaklamani

演示作者:弗吉尼亚·卡克拉马尼

About The Elacestrant Clinical Development Program

关于Elacestrant临床开发计划

Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer, alone or in combination with other therapies. EMERALD (NCT03778931) is a randomized Phase 3 trial, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients.

Elacestrant也正在接受几项由公司赞助的转移性乳腺癌临床试验的研究,这些试验单独或与其他疗法联合使用。EMERALD(NCT03778931)是一项随机3期临床试验,开放标签,主动对照研究,评估elacestrant作为ER+,HER2晚期/转移性乳腺癌患者的二线或三线单药治疗。

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.

ELEVATE(NCT05563220)是一项1b/2期临床试验,评估依来司群联合alpelisib,依维莫司,capivasertib,palbociclib,ribociclib或abemaciclib的安全性和有效性。ELECTRA(NCT05386108)是一项开放标签的1b/2期多中心研究,评估elacestrant联合abemaciclib治疗ER+,HER2乳腺癌患者。

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.

第二阶段部分评估了脑转移患者的这种治疗方案。。

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 study evaluating elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence.

ADELA(NCT06382948)是一项3期随机双盲试验,评估依拉司群联合依维莫司治疗ER+,HER2-mBC伴ESR1-mut肿瘤的患者。优雅(NCT06492616)是一项3期研究,评估elacestrant与标准内分泌治疗对淋巴结阳性,雌激素受体阳性,HER2阴性,复发风险高的早期乳腺癌患者的影响。

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..

Elacestrant也正在与其他公司合作进行的其他研究者主导的试验中进行评估,包括转移性乳腺癌和早期疾病。。

About ORSERDU (elacestrant)

关于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..

U、 适应症:ORSERDU(elacestrant),345毫克片剂,用于治疗绝经后女性或成年男性,雌激素受体(ER)阳性,人类表皮生长因子受体2(HER2)阴性,ESR1突变的晚期或转移性乳腺癌,至少接受一种内分泌治疗后疾病进展。。

Full prescribing information for the U.S. can be found at www.orserdu.com.

有关美国的完整处方信息,请访问www.orserdu.com。

Important Safety Information

重要安全信息

Warning and Precautions

警告和注意事项

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..

血脂异常:服用ORSERDU的患者发生高胆固醇血症和高甘油三酯血症的发生率分别为30%和27%。3级和4级高胆固醇血症和高甘油三酯血症的发生率分别为0.9%和2.2%。开始前和服用ORSERDU期间定期监测血脂。。

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.

胚胎-胎儿毒性:根据动物的研究结果及其作用机制,ORSERDU给孕妇服用时会导致胎儿伤害。建议孕妇和女性注意胎儿潜在风险的生殖潜力。建议有生殖潜力的女性在使用ORSERDU治疗期间和最后一剂后1周内使用有效的避孕措施。

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..

建议有生殖潜力的女性伴侣的男性患者在使用ORSERDU治疗期间和最终剂量后1周内使用有效的避孕措施。。

Adverse Reactions

不良反应

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)..

接受ORSERDU治疗的患者中有12%发生严重不良反应。接受ORSERDU治疗的患者中,>1%的严重不良反应是肌肉骨骼疼痛(1.7%)和恶心(1.3%)。接受ORSERDU治疗的患者中有1.7%发生致命不良反应,包括心脏骤停,感染性休克,憩室炎和不明原因(每位患者一名)。。

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%)..

ORSERDU最常见的不良反应(≥10%),包括实验室异常,是肌肉骨骼疼痛(41%),恶心(35%),胆固醇升高(30%),AST升高(29%),甘油三酯升高(27%),疲劳(26%),血红蛋白降低(26%),呕吐(19%),ALT升高(17%),钠降低(16%),肌酐升高(16%),食欲下降(15%),腹泻(13%),头痛(12%),便秘(12%),腹痛(11%),潮热(11%)和消化不良(10%)。。

Drug interactions

药物相互作用

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.

与CYP3A4诱导剂和/或抑制剂同时使用:避免与ORSERDU同时使用强或中度CYP3A4抑制剂。避免与ORSERDU同时使用强或中度CYP3A4诱导剂。

Use in specific populations

在特定人群中使用

Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.

哺乳期:建议哺乳期妇女在用ORSERDU治疗期间和最后一次给药后1周内不要母乳喂养。

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).

肝损伤:避免在严重肝损伤患者中使用ORSERDU(Child-Pugh C)。减少中度肝功能损害(Child-Pugh B)患者的ORSERDU剂量。

The safety and effectiveness of ORSERDU in pediatric patients have not been established.

ORSERDU在儿科患者中的安全性和有效性尚未确定。

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.

要报告疑似不良反应,请联系Stemline Therapeutics,Inc.,电话1-877-332-7961或FDA,电话1-800-FDA-1088或www.FDA.gov/medwatch。

About The Menarini Group

关于美纳里尼集团

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.

美纳里尼集团是一家领先的国际制药和诊断公司,拥有47亿美元的营业额和17000多名员工。美纳里尼专注于心脏病学、肿瘤学、肺脏学、胃肠病学、传染病、糖尿病、炎症和镇痛等需求未得到满足的治疗领域。

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..

美纳里尼拥有18个生产基地和9个研发中心,产品遍布全球140个国家。欲了解更多信息,请访问www.menarini.com。。

About Stemline Therapeutics Inc.

关于Stemline Therapeutics Inc。

Stemline Therapeutics, Inc. (“Stemline”) a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and Europe, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Stemline Therapeutics,Inc.(“Stemline”)是美纳里尼集团的全资子公司,是一家商业阶段的生物制药公司,专注于新型肿瘤治疗剂的开发和商业化。Stemline在美国和欧洲将ORSERDU®(elacestrant)商业化,这是一种口服内分泌疗法,用于治疗绝经后女性或成年男性,雌激素受体(ER)阳性,人类表皮生长因子受体2(HER2)阴性,ESR1突变的晚期或转移性乳腺癌,至少接受一种内分泌治疗后疾病进展。

Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the U.S.

Stemline还将ELZONRIS®(tagraxofusp-erzs)商业化,这是一种针对CD123的新型靶向治疗方法,用于美国和欧洲的侵袭性血液癌浆细胞样树突状细胞肿瘤(BPDCN)患者,这是美国唯一批准的BPDCN治疗方法。

and E.U. to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers..

。Stemline还在欧洲将多发性骨髓瘤的XPO1抑制剂NEXPOVIO®(selinexor)商业化。Stemline还在许多实体癌和血液癌的不同发展阶段拥有广泛的小分子和生物制剂临床渠道。。