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全球Wi-Fi HaLow解決方案領導廠商摩爾斯微電子（Morse Micro）宣布推出開創性的評估套件，透過完全整合的開發平台推進各產業物聯網解決方案。新推出的MM6108-EKH05評估套件運用Wi-Fi HaLow的優勢能力，支援從智慧家居裝置到工業自動化系統的廣泛應用。 此套件支援高達32.5 Mbps的資料傳輸速率以及低於1 GHz頻段的可程式化操作，是加速物聯網開發的必備工具。其開發板搭載摩爾斯微電子的MM6108（Wi-Fi HaLow低功耗系統單晶片）、STM32U585低功耗微控制器（MCU）以及BlueNRG-M2（Bluetooth®系統單晶片），提供穩定可靠的無線連接、先進的安全功能、低功耗特性以及豐富的可編程介面與感測器。這個完整且安全的平台是軟體工程師開發高效能物聯網解決方案的理想選擇。 MM6108-EKH05 Wi-Fi HaLow評估套件的主要特性包括：● Wi-Fi HaLow連線：支援長距離、低功耗的無線連接。● 高效能的STM32U585 MCU：專為低功耗應用設計。● 整合感測器：包括溫度、濕度、加速度計等感測器，以強化物聯網應用。● STLinkV3燒錄器：內建除錯器，可提升軟體評估效率。● 靈活的供電選項：支援USB、電池或外部電源，為開發者提供多樣化的配置選擇。● WPA3安全性：採用最先進的安全協定，確保物聯網應用的安全性與可靠性。● 快速部署：與STMCubeIDE相容的CMSIS-pack軟體可快速部署Wi-Fi HaLow解決方案，進而加速上市時程並降低開發成本。 「MM6108-EKH05評估套件體現了我們致力於為物聯網開發人員提供尖端技術的承諾，」摩爾斯微電子執行長暨共同創辦人Michael De Nil表示。「此套件結合了Wi-Fi HaLow的低功耗與長距離優勢，以及多功能編程介面和感測器，能滿足快速演進的物聯網生態需求。透過提供穩定、節能且易於使用的開發平台，並支援廣泛的連接選項，我們協助開發者在智慧城市到工業自動化等各領域開創嶄新局面。我們相信，這是讓全球產業邁向更具連接性、高效且安全之物聯網解決方案的關鍵。」 MM6108-EKH05現已在Mouser上架，為開發者提供無縫導入Wi-Fi HaLow技術的管道，從而推動各種物聯網應用的創新。此評估套件包含預先配置的硬體與軟體、SDK以及技術文件，以協助簡化原型開發流程。如需了解更多資訊， 請點此處參閱MM6108-EKH05產品簡介。 關於摩爾斯微電子的Wi-Fi HaLow產品組合摩爾斯微電子的Wi-Fi HaLow產品組合解決了物聯網應用在長距離、低功耗連接方面的挑戰，克服現有Wi-Fi版本的基本限制。摩爾斯微電子為Wi-Fi聯盟推動Wi-Fi HaLow互通性認證，做出積極貢獻，並協助開創802.11ah Wi-Fi HaLow標準，以滿足低功耗物聯網裝置的獨特需求。其產品組合包含業界體積最小、速度最快、功耗最低的Wi-Fi CERTIFIED HaLow SoC與模組。摩爾斯微電子的使用案例遍及整個物聯網生態系統，可使聯網設備的傳輸距離比傳統Wi-Fi網路長10倍，覆蓋面積達到傳統Wi-Fi網路的100倍，容量高達傳統Wi-Fi網路的1,000倍。 關於摩爾斯微電子總部位於澳洲雪梨的摩爾斯微電子是業界領先的Wi-Fi HaLow無晶圓廠半導體公司，並在全球各地設有分公司。該公司作為世界頂尖的Wi-Fi HaLow公司，引領物聯網（IoT）的次世代無線網路解決方案。摩爾斯微電子現已提供Wi-Fi CERTIFIED HaLow MM6108量產晶片樣本，這是市面上速度最快、體積最小、功耗最低且傳輸距離最長的Wi-Fi HaLow晶片。欲了解更多資訊，請至https://www.morsemicro.com/。
現實世界的證據證明 ORSERDU 對治療 ER+/HER2- ESR1 變異晚期或 mBC 病人的療效。 無論 ESR1 的突變狀況如何，elacestrant 與 abemaciclib 結合使用的更新結果顯示出正面效果，在 ER+/HER2- mBC 病人中具有可控制和可預測的安全性。 意大利佛羅倫斯和紐約2024年11月27日 /美通社/ -- 國際領先的製藥和診斷公司 Menarini Group（「Menarini」）和 Menarini Group 全資附屬公司 Stemline Therapeutics Inc.（「Stemline」），專注於為癌症病人帶來轉型腫瘤治療，將在即將於 2024 年 12 月 10 至 13 日舉行的 2024 年聖安東尼奧乳癌研討會 (SABCS) 上發表 ORSERDU® (elacestrant) 的新擴展數據。值得注意的是，此公司將為 ER+/HER2-、晚期或轉移性乳腺癌 (mBC) 的成年病人提供 ORSERDU 的實際疾病無惡化存活期 (rwPFS) 結果。此外，公司還將展示 elacestrant 加 abemaciclib 的最新療效結果，以及 ELECTRA 和 ELEVATE 試驗 1b/2 期的綜合安全性分析。 ORSERDU 的實際疾病無惡化存活期 (rwPFS) 資料 ORSERDU 是第一款也是唯一一款獲批准用於針對 ESR1 突變腫瘤的口服雌激素受體抗劑 (SERD)，這種腫瘤發生在多達 50% 的 ER+、HER2-晚期或 MBc 腫瘤中，因此在轉移環境中之前接觸內分泌治療 (ET)。自美國食品藥品監督管理局 (FDA) 於 2023 年 1 月批准以來，在目前的 mBC 治療環境中，ORSERDU 的實際使用情況已經過了足夠的時間來定性。 SABCS 2024 年會報告的結果顯示 ORSERDU 對 ER+/HER2- 晚期或 mBC 病人的實際療效。整體人口分析顯示中位 rwPFS 為 6.8 個月。已往接受過 1-2 種 ET 的 mBC 病人的中位 rwPFS 為 8 個月。在分析中，觀察到的 rwPFS 在各個副群組中為一致。來自其他病人副群組的最新結果和其他資訊，將在大會上發表。 完整摘要 (SESS-1876) 可在此處查看 (第 1748 頁)。 「這些令人興奮的數據，顯示 ORSERDU 單一療法有臨床意義的真實世界無惡化存活率。」MD Anderson Cancer Center 的 UT Health San Antonio 乳腺腫瘤內科醫生兼醫學教授 Virginia Kaklamani 博士說。「作為執業醫生，這些結果強調了在每次疾病進展時，使用液體活檢測試病人腫瘤的 ESR1 基因突變，是相當有必要的，這樣我們就可以為病人度身定制適當的治療方案，優化病人護理。」 Elacestrant 與 Abemaciclib 併用研究 (Elacestrant Plus Abemaciclib Combination Study) ELEVATE 和 ELECTRA 1b/2 期研究的設計目標，均透過克服腫瘤對 ET 的抗藥性，評估結合治療方案對病人的療效。 SABCS 2024 年會報告的結果，包括 ELECTRA 研究的最新療效結果，其無疾病存活期 (PFS) 數據相當良好。在所有有療效的中，中位疾病無惡化存活期 (mPFS) 為 8.6 個月。在有 ESR1 突變的病人中，MPF 為 8.7 個月。在沒有 ESR1 突變的病人中，MPF 為 7.2 個月。 此外，對 ELECTRA 和 ELEVATE 病人的綜合安全分析顯示，在 ER+/HER2-MBc 病人中使用 elacestrant 加 abemaciclib 治療的病人，以及先前接受過一種或多種療法者，會讓病人的安全性狀況可控制和可預測。對所有接受此複方治療的病人進行安全性評估，結果與兩種化合物的已知安全性相符。最常見的全程不良事件 (AEs) (≥ 20%) 是腹瀉、噁心、中性粒細胞減少、嘔吐、疲勞、貧血和食慾下降。沒有觀察到 4 級 AEs。 完整摘要 (SESS-1910) 可在此處瀏覽 (第 3330 頁)。 加州大學舊金山大學 (University of California San Francisco) 乳腺腫瘤學與臨床試驗教育主任醫學教授 Hope S.Rugo 表示：「Elacestrant 與 Abemaciclib 併用的最新結果，繼續顯示出令人鼓舞的疾病無惡化存活期數據，以及良好的安全性，在這些藥物併用時沒有出現任何新的毒性信號。Elacestrant 繼續顯示出有潛力成為轉移性乳癌結合療法的內分泌治療骨幹，我們很高興能隨著這些試驗的進展，進一步探索這種治療組合。」 Menarini Group行政總裁 Elcin Barker Ergun 表示：「在真實的環境中看到這些無進化的生存結果很令人興奮，這表明 ORSERDU 為腫瘤科醫生帶來了有意義的益處，可以為病人帶來實際益處。我們致力於推進我們對 elacestrant 的強大臨床研究計劃，並在單治療和組合治療環境中發揮其全部潛力，目標是將 ORSERDU 帶給新的病人群體，使其受益。」 Menarini Stemline 還將分享三期 EMERALD 試驗的其他相關數據的結果，以及進行中的幾項試驗。 Menarini Stemline 摘要完整清單： 標題：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海報編號：P3-10-08日期與時間：十二月十二日（星期四）中午 12 時至 2 時，美國標準時間地點：TBC介紹作者：Elyse Swallow 標題： Elacestrant plus abemaciclib (abema) combination in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer (mBC)海報編號：PS7-07日期與時間：十二月十二日（星期四），上午 7 時至 8 時 30 分，美國標準時間地點：TBC介紹作者：Hope Rugo 標題：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海報號碼：PS7-06日期與時間：十二月十二日（星期四）上午 7 時至 8 時 30 分，美國標準時間地點：TBC介紹作者：Hope Rugo 標題： 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海報號碼：P1-01-25日期與時間：十二月十一日（星期三）中午十二時至二時正，美國標準時間地點：TBC介紹作者：Aditya Bardia 標題： 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海報號碼：P2-08-21日期與時間：十二月十一日（星期三）下午 5 時 30 分至 7 時 30 分，美國標準時間地點：TBC介紹作者：Aditya Bardia 標題： 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海報號碼：P2-10-21日期與時間：十二月十一日（星期三）下午 5 時 30 分至 7 時 30 分，美國標準時間地點：TBC介紹作者：Antonio Llombart-Cussac 標題： 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海報號碼：第 2-08-20日期與時間:十二月十一日（星期三）下午 5 時 30 分至 7 時 30 分，美國標準時間地點：TBC介紹作者：Virginia Kaklamani Elacestrant 臨床發展計劃簡介 Elacestrant 同時正在數項公司贊助的轉移性乳癌臨床試驗中進行研究，可單獨使用或與其他療法結合使用。EMERALD (NCT03778931) 是一項隨機第 3 期臨床研究階段、開放標籤、活性對照研究，評估 elacestrant 作為 ER+、HER2- 晚期/轉移性乳癌病人的二線或三線單一療法。ELEVATE (NCT05563220) 是一項第 1b/2 期臨床研究階段，評估 elacestrant 與 alpelisib、everolimus、capivasertib、palbociclib、ribociclib 或 abemaciclib 併用的安全性和療效。ELECTRA (NCT05386108) 是一項開放式第 1b/2 期多中心臨床研究階段，評估 elacestrant 組合使用 abemaciclib 對 ER+、HER2- 乳癌病人的療效。第 2 階段亦評估給腦轉移病人使用這種治療方案的成果。ELCIN (NCT05596409) 是一項第 2 期臨床研究階段，評估此類藥物對於曾接受一或兩種荷爾蒙療法的 ER+、HER2- 末期/轉移性乳腺癌病人，且在癌症轉移情況下未曾使用過 CDK4/6 抑製劑的病人是否有效。ADELA (NCT06382948) 是一項第 3 期隨機、雙盲試驗，評估 elacestrant 組合使用 everolimus 治療患有 ESR1 突變腫瘤的 ER+、HER2- mBC 病人。ELEGANT (NCT06492616) 是一項第 3 期臨床研究，評估 Elacestrant 相較於標準內分泌療法，是否適用於罹患結節陽性、雌激素受體陽性、HER2 陰性、早期乳癌且復發風險高的女性與男性病人。Elacestrant 也正在其他研究者主導的試驗中，以及與其他公司合作進行的試驗中，針對轉移性乳癌和早期疾病進行評估。 ORSERDU (elacestrant) 簡介 U.S. Indication:ORSERDU (elacestrant)，345 毫克片劑，適用於治療雌激素受體 (ER)為陽性、人類表皮生長因子受體 2 (HER2) 為陰性、ESR1- 至少曾使用過一線內分泌治療後、疾病惡化的突變末期或轉移性乳癌病人。 適用於美國的完整處方資訊，可查閲 www.or serdu.com。 重要安全資訊 警告和注意事項 高脂血症：在接受 ORSERDU 治療的患者中，30% 出現高膽固醇血症，27% 出現高三酸甘油脂血症。3 級和 4 級高膽固醇血症和高三酸甘油脂血症的發生率分別為 0.9% 和 2.2%。在開始 ORSERDU 治療前以及治療期間須定期監測血脂情況。 胚胎-胎兒毒性：根據動物研究的發現及其作用機制，為孕婦處方 ORSERDU 可能會對腹中的胎兒造成傷害。請向孕婦和具有生育能力的女性告知可能對胎兒造成的風險。建議具有生育能力的女性在接受 ORSERDU 治療期間直至服用最後一劑後的 1 週內，使用有效的避孕方法。對於男性患者的、有生育能力的女性伴侶，建議在接受 ORSERDU 治療期間到最後一劑後的 1 週內，使用有效的避孕方法。 不良反應 有 12% 的服用 ORSERDU 患者發生嚴重不良反應。接受 ORSERDU 治療的患者中，發生嚴重不良反應的患者比例超過 1%，這些反應包括肌肉骨骼疼痛 (1.7%) 和噁心 (1.3%) 。1.7% 接受 ORSERDU 治療的患者出現致命的不良反應，包括心臟驟停、敗血性休克、憩室炎和原因不明的情況（各一例）。ORSERDU 最常見的不良反應 (≥ 10％)，包括實驗室異常，ORSERDU 有肌肉骨骼疼痛 (41%)、噁心 (35%)、膽固醇增加 (30%)、AST 增加 (29%)、三酸甘油脂增加 (27%)、疲勞 (26%)、血紅蛋白減少 (26%)、 嘔吐 (19%)、ALT 增高 (17%)、鈉降低 (16%)、肌酸酐增高 (16%)、食慾降低 (15%)、腹瀉 (13%)、頭痛 (12%)、便秘 (12%)、腹痛 (11%)、潮熱 (11%) 及消化不良 (10%)。 藥物相互作用 與 CYP3A4 誘導劑和/或抑製劑同時使用：避免與強效或中度 CYP3A4 抑制劑和 ORSERDU 一起使用。避免與強效或中度 CYP3A4 誘導劑和 ORSERDU 一起使用。 使用於特定群組的注意事項 哺乳期：建議哺乳期婦女在接受 ORSERDU 治療期間直到最後一劑後的 1 週內不要哺乳。 肝功能受損：避免給嚴重肝功能受損 (Child-Pugh C) 的患者使用 ORSERDU。中度肝功能受損 (Child-Pugh B) 的患者要減少 ORSERDU 的劑量。 ORSERDU 在兒科患者中的安全性和有效性尚未確定。 如要報告懷疑不良反應，請致電 1-877-332-7961 聯絡 Stemline Therapeutics, Inc.，或致電 1-800-FDA-1088 聯絡美國食品藥物管理局 (FDA) ，或訪問 www.fda.gov/medwatch。 The Menarini Group簡介 The Menarini Group是一家領先的國際醫藥和診斷公司，年營業額超過47億美元，擁有超過17000名員工。Menarini 專注於研發治療需求未被滿足的領域，其產品涵蓋心臟病學、腫瘤學、呼吸病學、胃腸病學、傳染病學、糖尿病學、炎症和鎮痛等領域。Menarini 擁有 18 個生產基地和 9 個研發中心，產品銷往全球 140 個國家/地區。欲了解更多相關資訊，請瀏覽 www.menarini.com。 Stemline Therapeutics Inc. 簡介 Stemline Therapeutics, Inc. (「Stemline」) 是 Menarini Group 的全資子公司，是一家商業化階段的生物製藥公司，專注於新型腫瘤學治療藥物的開發和商業化。Stemline 將於美國和歐洲商業化 ORSERDU® (elacestrant) ，這是一種口服內分泌治療藥物，適用於患有雌激素受體 (ER) 陽性、人表皮生長因子受體 2 (HER2) 陰性、ESR1 突變的末期或轉移性乳癌，且在接受至少一線內分泌治療後病情惡化的絕經後女性或成年男性。Stemline 還在美國和歐洲推出 ELZONRIS® (tagraxofusp-erzs) ，這是一種針對 CD123 的創新標靶治療，用於治療爆發性漿細胞樹突細胞腫瘤 (BPDCN)（一種侵襲性血液癌症）患者，也是美國和歐盟迄今唯一獲批的 BPDCN 治療方案。NEXPOVIO® (selinexor) 是一種用於治療多發性骨髓瘤的 XPO1 抑制劑，Stemline 亦將其於歐洲商業化 。此外，Stemline 還擁有廣泛的小分子和生物製劑臨床產品管道，這些產品處於不同的開發階段，可用於治療多種實體癌和血癌。
SINGAPORE, Nov. 27, 2024 /PRNewswire/ -- Vectra AI, Inc., the leader in AI-driven XDR (extended detection and response) today announced the extension of its long-term partnership with Globe Telecom, the largest mobile network provider in the Philippines. This collaboration aims to bolster Globe Telecom's cybersecurity operations across its network. Key improvements from this partnership have enabled Globe Telecom to reduce alert noise by 99% and significantly enhance its security posture, ensuring reliable services for over 80 million customers. Leveraging Vectra AI's solutions, Globe Telecom has cleared a fog of cyber threats across its extensive infrastructure within a year. The integration of AI-powered Attack Signal Intelligence™ provided detailed insights previously missed across its broader network, while the Network Detection and Response combined with CrowdStrike's EDR offered complete visibility across both network and end-point activities. After implementing Vectra AI's solutions, Globe's incident response time decreased to 3.5 hours, with a 99% reduction in noise and escalations. Anton Bonifacio, Chief Information Security and Chief AI Officer at Globe Telecom, explains, "With Vectra in place, the light started to turn on. Its automation and filtering capabilities allowed us to focus on the most important threats, which made our team more efficient and effective in our response." With a clearer understanding of their network activity, Globe Telecom's security team was able to maintain tighter control over their environment. Additionally, having a comprehensive view of east-west traffic and lateral movement allowed them to uncover hidden threats before any damage could occur. Aylwin Lam, Regional Director for Vectra AI Asia, comments, "Ultimately, for security decision makers today, it's about focusing on what's urgent, by having the best view possible of the entire infrastructure and subsequent threats, assessed by severity and impact." As an extra layer of defence, Vectra's MDR (Managed Detection and Response) service provided round-the-clock support, offering continuous alert management, threat hunting and expert analysis. With additional eyes on their network, Vectra MDR secured the frontline — enabling the Globe Telecom team to concentrate on high-priority alerts that demand immediate action. "The MDR aspect was a key differentiator for us. Vectra's MDR team and their threat-hunting expertise have been invaluable in helping us secure our environment," Bonifacio said. A recent Vectra AI report revealed that 73% of APAC security practitioners believe their organisations may have been compromised without their knowledge due to alert overload. Additionally, there is a growing disconnect between SOC practitioners and security vendors, with many (45%) expressing dissatisfaction with their current tools. As for Globe Telecom, Bonifacio underscores the value of this collaboration, stating, "One thing that truly stands out about Vectra AI is the strong relationship we've built. They've always been a supportive partner, even during challenging times, and we really appreciate that." Lam concludes, "Vectra AI is proud to provide real-time visibility and MDR services to Globe Telecom, helping to eliminate threats and maintain reliable services for their 80 million customers."
Real-world evidence bolsters the efficacy of ORSERDU for the treatment of patients with ER+/HER2- ESR1-mut advanced or mBC. Updated results of elacestrant in combination with abemaciclib show favorable efficacy regardless of the ESR1 mutation status, with a manageable and predictable safety profile in patients with ER+/HER2- mBC. FLORENCE, Italy and NEW YORK, Nov. 26, 2024 /PRNewswire/ -- 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. 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. 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. 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. Updated results and additional information from other patient subgroups will be presented at the congress. The full abstract (SESS-1876) can be viewed here (page 1748). "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." 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. In patients without an ESR1 mutation, mPFS was 7.2 months. 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. 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. The full abstract (SESS-1910) can be viewed here (page 3330). "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. "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." "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." Menarini Stemline will also share results of other relevant data from the Phase 3 EMERALD trial, as well as several trials in progress. Complete List of Menarini Stemline Abstracts: 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 StatesPoster Number: P3-10-08Date & Time: Thursday, December 12, 12-2 PM CSTLocation: TBCPresenting 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)Poster Number: PS7-07Date & Time: Thursday, December 12, 7-8:30 AM CSTLocation: TBCPresenting Author: 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 studyPoster Number: PS7-06Date & Time: Thursday, December 12, 7-8:30 AM CSTLocation: TBCPresenting Author: 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 trialPoster Number: P1-01-25Date & Time: Wednesday, December 11, 12-2 PM CSTLocation: TBCPresenting Author: 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 studyPoster Number: P2-08-21Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: 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 CDK4/6iPoster Number: P2-10-21Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: Antonio Llombart-Cussac 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 studyPoster Number: P2-08-20Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: Virginia Kaklamani About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer, alone or in combination with other therapies. 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. 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 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. 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 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 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. 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.
HSINCHU, Nov. 26, 2024 /PRNewswire/ -- ASPEED Technology, a leader in 360-degree immersive imaging solutions, and its subsidiary Cupola360 Inc., have collaborated with Foxconn Industrial Internet (Fii), a subsidiary of Hon Hai Technology Group (Foxconn), to successfully implement the Cupola360 smart patrol solution at its Bac Giang facility in Vietnam. This facility recently earned the prestigious designation of "Lighthouse Factory" from the World Economic Forum (WEF), making it the first facility in Vietnam to achieve this recognition. Building on ASPEED Technology's 2023 success in developing the world's first AI server Lighthouse Factory at the NanChing facility in Taoyuan, the achievement at Bac Giang underscores the transformative impact of Cupola360's panoramic remote management technology in driving smart manufacturing advancements. The Cupola360 smart patrol solution leverages ASPEED's proprietary panoramic stitching technology to provide seamless 720-degree real-time monitoring for the Bac Giang facility. Through its immersive visual management system, the operations team can perform remote patrol, anomaly detection, and virtual tours without the need for on-site visits. By integrating third-party AI analytics, the system can identify irregularities in real-time and automatically notify managers for swift resolution. This innovative approach not only reduces reliance on traditional SCADA systems but also minimizes travel-related carbon emissions, supporting corporate ESG goals for sustainability. "Vietnam, as a developing country, is free from the burden of legacy equipment often seen in advanced economies. Newly built factories can directly adopt state-of-the-art technologies, rapidly enhancing their competitive edge," said CJ Hsieh, COO of ASPEED Technology. "Our latest panoramic visual technology significantly lowers the AI computing power required by traditional cameras. Furthermore, it aligns with the sovereign AI trend, granting businesses the flexibility to independently develop and upgrade their AI systems. Without relying on conventional camera providers, companies can accelerate innovation and achieve faster progress. By implementing the sovereign AI-powered Cupola360 solution into the Bac Giang facility, we have demonstrated the immense potential of panoramic visual management while setting new benchmarks for remote AI management in the manufacturing sector." The Bac Giang facility has achieved remarkable improvements in production efficiency through the large-scale application of AI and automation. According to WEF's evaluation, labor productivity increased by 190%, on-time delivery rates reached 99.5%, and manufacturing costs were reduced by 45%. These results underscore the ability of digital management to drive sustainable development and serve as a valuable reference for other global production facilities. The Head of Development Strategy at the Bac Giang facility, Michael Wang, shared from his practical experience: "By combining Cupola360's panoramic technology with AI analytics, we have achieved transparent data management and intelligent remote monitoring across the facility. This enables our team to identify and resolve issues promptly, significantly enhancing decision-making efficiency and overall operational performance." The WEF's "Lighthouse Factory" designation represents the pinnacle of global standards in smart manufacturing and digital operations. Companies earning this title undergo rigorous evaluations, showcasing not only innovative technological integration but also a strong commitment to sustainable practices. With the success of Cupola360 at the Bac Giang facility, ASPEED Technology has set a new benchmark for remote management in manufacturing. Looking ahead, ASPEED plans to continue advancing innovation through Cupola360, empowering more manufacturing partners to achieve digital transformation and ushering in a new era of high efficiency and sustainable growth. About ASPEED Technology Inc. Founded in 2004, ASPEED Technology Inc. is a leading fabless IC design company headquartered in Hsinchu, Taiwan. As a pioneer and leader of cutting-edge SoC solutions with a focus on the niche markets, ASPEED specializes in Cloud & Enterprise Solutions, including Baseboard Management Controller (BMC) SoC, Bridge IC, and PFR SoC, and Smart AV Solutions, including AVoIP SoC, Cupola360 spherical image stitching processor and Cupola360⁺ Software Kit. ASPEED is devoted to developing innovative technologies to quickly respond to customer needs. In 2016, ASPEED acquired Broadcom's Emulex Pilot™ remote server management chip business and it's currently the world's No. 1 BMC SoC provider. To enter the market of image processing, ASPEED expanded its product portfolio by launching Cupola360 spherical image stitching processor and Cupola360⁺ software solutions in 2018. Recognized as a trusted and reliable partner for customers, ASPEED has been awarded "Forbes Asia's 200 Best Under a Billion" for ten consecutive years since 2014. The company was also recognized as "Taiwan Best-in-Class 100" by Taiwan Institute of Directors and CDRC Consulting Group in 2022-2023 and "Best Management Team in Asia" by Institutional Investor in 2023. For more information, please visit www.aspeedtech.com. About Cupola360 Inc. Cupola360 Inc., established in 2018, is a subsidiary of ASPEED Technology, a leading IC design company headquartered in Hsinchu, Taiwan. Cupola360 provides comprehensive real-time and AI-friendly 360-degree imaging turnkey solutions, creating a seamless and immersive first-person experience. By leveraging ASPEED's Cupola360 Spherical Image Processors, Cupola360 has introduced a range of panoramic cameras and deployment software. The collaboration extends to ecosystem partners, including AI service providers, system integrators, and distributors to introduce solutions for various applications such as smart patrol, smart cities, video conferencing, and more. For more information, please visit https://cupola360.com/en/.
● 透過恩智浦首款整合乙太網路時間敏感型網路（time-sensitive networking；TSN）交換器的i.MX應用處理器系列，整合實時處理與工業網路通訊協定支援，實現工業控制 ● 恩智浦首款整合後量子密碼學（post-quantum cryptography；PQC）技術的應用處理器系列，防範量子電腦攻擊 ● 運用恩智浦整合的eIQ Neutron神經處理單元（Neural Processing Unit；NPU）幫助減少意外停機的發生 【臺北訊，2024年11月26日】全球半導體領導廠商恩智浦半導體（NXP Semiconductors N.V.; NASDAQ：NXPI）宣佈推出i.MX 9系列應用處理器最新成員i.MX 94系列，該系列旨在用於工業控制、可編程邏輯控制器（programmable logic controller；PLC）、遠端資訊處理、工業和車用閘道、以及建築和能源控制。 安全的實時通訊對於工業和汽車應用至關重要，日益複雜的工業環境依賴多種通訊協定，需要智慧TSN交換器來管理實時通訊和控制需求。在汽車產業，隨著向軟體定義汽車加速轉型，使得底層車輛架構越來越依賴基於乙太網路的通訊。 透過將通訊、安全性和實時控制功能整合至單一SoC，i.MX 94系列可協助設計人員應對持續增長的複雜性，確保在協調實時通訊和操作時最佳化端到端效能。整合的2.5 Gbps乙太網路TSN交換器支援高度可配置的安全通訊，為工業和汽車應用提供豐富的協定支援。 恩智浦半導體資深副總裁暨工業與物聯網事業部總經理Charles Dachs表示：「如今的連接功能要求比以往更加複雜，i.MX 94系列目的在簡化這種複雜性。i.MX 94系列提供適用於當前工業自動化和汽車遠端資訊處理應用所需的高效能邊緣處理能力，具備未來創新所需的先進網路、安全性、可靠性和人工智慧功能。」 多核心設計提供高效能、低延遲智慧邊緣處理 i.MX 94系列64位元應用處理器採用多核心設計，配備多達四個能夠運行Linux的Arm® Cortex®-A55核心，以及兩個Cortex-M33核心和兩個Cortex-M7核心，用於增強實時處理能力。恩智浦的實時邊緣軟體框架幫助開發人員能夠實現實時和應用級任務的最佳組合設計，這些任務可以跨不同核心運行。此外，也支援QNX Neutrino和Green Hills Integrity等各種第三方廠商專用商用作業系統，以充分運用其運算能力。該系列還具備整合功能安全島（functional safety island）和可配置的安全分區，符合IEC61508 SIL2和ISO26262 ASIL-B標準。 專為複雜網路環境打造 作為i.MX應用處理器的新成員，i.MX 94系列率先整合2.5 Gbps乙太網路TSN交換器，具備快速初始化並支援低功耗模式的特性。恩智浦的實時邊緣軟體支援多種工業協定，涵蓋傳統已廣泛採用到最新開發的協議，如OPC-UA FX和OPC-UA PubSub等。憑藉硬體支援網路虛擬化，i.MX 94系列還支援軟體定義網路，對於實現基於XDP和DPDK等開放標準的複雜多核心應用場景是非常關鍵的技術。i.MX 94系列支援傳統串列現場匯流排協定，如Profibus、Modbus、CANopen和IO-Link，以及基於乙太網路的實時網路通訊協定，如Profinet、EtherCAT、Ethernet/IP和CC-Link等。此外，還支援這些協議的TSN實踐場景，包括AVB/TSN、乙太網路OPC-UA和Profinet Over TSN等。因此，i.MX 94系列非常適合當前和未來的工業自動化應用。 先進安全防護抵禦量子攻擊 i.MX 94系列是恩智浦首款支援後量子（post-quantum）公開金鑰密碼學（public key cryptography）的應用處理器，能夠抵禦量子電腦攻擊，並在長期的生命週期內管理裝置的安全性。整合的EdgeLock Secure Enclave高階版可設置裝置並隨時將其恢復至可信任的狀態，同時提供基於後量子密碼學處理器的安全啟動、安全偵錯和安全更新等高階安全功能，而且不會影響效能。此外，它還具備運行時防護功能，如驅逐攻擊者並自動恢復至可信任狀態，以及EdgeLock 2GO金鑰管理。 針對工業TSN和汽車連接應用，i.MX 94整合EdgeLock Accelerator高階版加密加速器，可實現快速啟動，以及透過5G速度進行實時高速訊息簽名、身分驗證和加密，確保通訊安全。 i.MX 94系列支援IEC 62443和ISO 21434等安全標準，以及即將實行的歐盟資安韌性法案（European Cyber Resilience Act）等法規，讓OEM廠商和資產所有者能夠應對並從現場網路事件恢復，保持裝置可用性並降低攻擊影響。 整合NPU實現人工智慧與機器學習功能 透過恩智浦eIQ機器學習軟體開發環境的支援，恩智浦eIQ Neutron NPU具備0.5 TOPS的機器學習效能，可提供實時預測性維護和操作指導以及缺陷掃描和機器診斷。NPU提供高度靈活且可擴展的安全功能，透過機器學習輔助的網路安全進行入侵偵測和保護，確保未來關鍵系統和基礎設施免受篡改。 跨系統解決方案的全面開發人員支持 i.MX 94系列提供跨i.MX產品組合的廣泛可擴展性，支援系統級設計方法。這包括支援恩智浦聯合開發的成本最佳化電源管理解決方案PF9455 PMIC。i.MX 94系列無縫整合恩智浦廣泛的無線解決方案產品組合，包括適用於工業和物聯網應用的IW612三頻無線解決方案，支援Wi-Fi 6、藍牙® 5.2和802.15.4，可輕鬆連接不同協定和生態系統的智慧裝置。此外還包括高度整合的AW693 SoC，透過雙頻併行Wi-Fi 6E和藍牙5.3提供先進的汽車安全性，可在車內實現多個安全連接功能，支持向軟體定義汽車的過渡期。 供貨情況 i.MX 94系列預計將於2025年第一季提供樣品。更多相關訊息，請參閱：NXP.com/iMX94。 ##### 關於恩智浦半導體 恩智浦半導體（NASDAQ：NXPI）身為值得信賴的合作夥伴，持續針對汽車、工業與物聯網、行動裝置與通訊基礎設施市場，提供創新解決方案。秉持「攜手共創輝煌未來」企業理念，恩智浦致力創造領先業界的尖端技術並匯聚精英才智，開發系統解決方案，讓互聯世界變得更美好、更安全、更有保障。恩智浦在全球逾30個國家設有業務機構，2023年公司全年營業額達到132.8億美元。更多恩智浦相關訊息，請參閱官方網站：https://www.nxp.com/。 恩智浦、eIQ、EdgeLock、恩智浦標誌是恩智浦公司的商標。所有其他產品或服務名稱均為其各自所有者的財產。保留所有權利。© 2024 NXP B.V Arm和Cortex是Arm Limited（或其子公司或關係企業）在美國和/或其他地區的商標和/或註冊商標。相關技術可能受到任何或所有專利、版權、設計和商業秘密的保護。保留所有權利。
A12 藝術空間
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