Artificial Intelligence
Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation
Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease¹; more than 147,000 breast cancer patients in Europe die annually from the disease²If approved by the European Commission, ORSERDU would be the first and only treatment specifically indicated for patients with ER+, HER2- advanced or metastatic breast cancer tumors that harbor ESR1 mutationsESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers, and are a known driver of resistance to standard endocrine therapy, making these tumors more difficult to treatFLORENCE, Italy and NEW YORK, July 21, 2023 /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, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ORSERDU® (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)–positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, Stemline and its affiliates will commercialize the product within Europe. ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations. ESR1 mutations are acquired mutations that develop as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
“Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options. ORSERDU may become the first product, if approved by the European Commission, indicated in ER+, HER2- advanced breast cancer with ESR1 mutations, which are a strong driver of resistance to treatment in up to 40% of patients in second line mBC. ORSERDU, if approved, will also provide a convenient daily oral treatment,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of today’s positive CHMP opinion as it reflects our commitment to developing innovative solutions that address the greatest unmet needs in cancer treatment, and brings us one step closer to providing an important new option to the patients and families impacted by ESR1-mutated, ER+, HER2- metastatic breast cancer.”
The positive CHMP opinion for ORSERDU is supported by data from the Phase 3 EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with elacestrant versus standard-of-care (SOC), defined as investigator’s choice of an approved endocrine monotherapy. The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
A post hoc subgroup analysis of the EMERALD PFS results, which were presented at the San Antonio Breast Cancer Symposium (SABCS) 2022, demonstrated that the duration of prior CDK4/6i treatment was positively associated with longer PFS on elacestrant but not with SOC. For patients with ESR1 mutations who were treated with CDK4/6i for ≥12 months prior to randomization on EMERALD, elacestrant achieved a median PFS of 8.6 months versus 1.9 months on SOC, with a 59% reduction in the risk of progression or death (HR=0.41 95% CI: 0.26-0.63).³
“As an oncologist, it is remarkable that we are on the cusp of having the first treatment option for patients with advanced or metastatic ER+, HER2- breast cancer harboring ESR1 mutations, which occur in up to 40% of patients in the metastatic setting,” said Giuseppe Curigliano, MD, PhD, Professor of Medical Oncology at the University of Milano and the Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy. “Elacestrant has demonstrated efficacy and a manageable safety profile, underscoring the potential benefit this therapy may soon bring to the patients we care for, and to the broader oncology community.”
Safety data were consistent with previously reported results. Serious adverse reactions reported in ≥ 1% of patients included nausea, dyspnoea, and thromboembolism (venous). The most common (≥ 10%) adverse reactions with ORSERDU were nausea, triglycerides increased, cholesterol increased, vomiting, fatigue, dyspepsia, diarrhoea, calcium decreased, back pain, creatinine increased, arthralgia, sodium decreased, constipation, headache, hot flush, abdominal pain, anaemia, potassium decreased, and alanine aminotransferase increased. The most common Grade ≥3 (≥2%) adverse reactions of elacestrant were nausea (2.7%), AST increased (2.7%), ALT increased (2.3%), anaemia (2%), back pain (2%), and bone pain (2%).
About the EMERALD Phase 3 Study (NCT03778931)
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.
The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc. The Menarini Group is now fully responsible for global registration, commercialization, and further development activities for elacestrant.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 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 United States, 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 US and EU to date. Stemline also commercializes Nexpovio® 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.
¹ Decision Resource Group / Clarivate Breast Cancer Landscape / Epidemiology – June 14, 2023
² International Agency for Research on Cancer, World Health Organization – Globocan – 2020
³ Bardia et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022. GS3-01
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Artificial Intelligence
TeraBox Celebrates 2nd Anniversary of Its Massively Popular Referral Program
Continuously expanding webmaster signups, especially in multiple regions, along with new highs in webmaster payouts, has ensured the smooth operation and continuous development of the project.
TOKYO, Sept. 21, 2024 /PRNewswire/ — TeraBox (“TeraBox” or “the Company”), a globally trusted cloud storage service headquartered in Tokyo, recently celebrated the second anniversary of its hugely popular Referral Program, a testament to the smooth operation and continuous development of the project. The number of webmaster signups, including in multiple new regions, continued to increase steadily with webmaster payouts reaching new highs.
TeraBox reveals some of its impressive Referral Program data.
TeraBox’s total number of webmasters worldwide reached over one million.The highest daily income of webmasters reached over $10,000, with the top earner making nearly $180,000.The total number of shares by all webmasters exceeds 500 million.The network of webmasters spans across the globe, including countries such as India, Indonesia, the United States, Latin America, Middle East, and South Korea. Moreover, as TeraBox’s influence continues to grow, the platform is excited to welcome many new webmasters from an expanding range of countries and regions.
TeraBox has achieved significant milestones, demonstrating its sustainable growth and increasing user impact. The journey started with the Webmaster Center launch in August 2022. Following this, several optimizations were implemented, including a self-withdrawal feature that simplified earnings management for webmasters and increased their engagement. Additionally, the Growth Analysis tool provided webmasters with valuable insights into their operational performance, enabling more effective decision-making.
As a result of these enhancements, both the number of participating webmasters and their earnings have seen remarkable increases. Looking ahead, the upcoming launch of the Webmaster App in September 2024 is set to further elevate user engagement and convenience, solidifying TeraBox’s position as an industry leader.
About TeraBox
TeraBox, developed by Flextech Inc. in Japan, is a leading global cloud storage solution. Headquartered in Tokyo, TeraBox proudly serves over 320 million users globally, providing an easy yet powerful way to store and manage data. With its generous 1TB of free storage, TeraBox ensures that your files are safe, secure, and accessible from anywhere. As a secure, reliable, and convenient service, TeraBox is certified with ISO 27001, ISO 27701, and ISO 27018, offering individual users around the world the opportunity to register for 1TB (1024GB) of free storage.
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SHANGHAI, Sept. 20, 2024 /PRNewswire/ — During HUAWEI CONNECT 2024, Huawei Cloud hosted a Summit themed “One Step to Intelligence, One Leap to Excellence”, gathering global industry leaders to explore the intelligent transformation trend, share pioneering cases, and assist customers in their journey to cloud-based operational excellence. At the summit, Huawei Cloud and global customers, unveiled the Data Center-to-Cloud solution and the PRIME Framework white paper.
Jacqueline Shi, President of Huawei Cloud Global Marketing and Sales Service, said: “Customers’ support enables us to innovate with finance, retail, autonomous driving, the Internet and many other sectors. By combining cutting-edge technologies with industry know-how, Huawei Cloud paves your way to digital and intelligence.”
Kevin Gao, President of Huawei Cloud Public Cloud Business, presented a keynote speech “One Step to Intelligence, One Leap to Excellence”. He outlined three critical factors for accelerating cloud migration and AI use: global infrastructure, continuous technological innovation, and lean operations.
In terms of global infrastructure, Huawei Cloud’s global infrastructure, KooVerse, offers extensive coverage, exceptional experience, and excellent quality. With 33 Regions and 93 Availability Zones (AZs) worldwide, Huawei Cloud supports over 10,000 customers in achieving business globalization. Huawei Cloud has interconnected with over 2,400 peers of global carriers, ensuring one hop to cloud and global business deployment for customers. Huawei Cloud data centers achieve Tier IV reliability.
Technological innovation is at the heart of Huawei Cloud’s mission to accelerate enterprise transformation. At this summit, three key areas were highlighted: compute upgrade, data-AI convergence, and application innovation.
The Data Center-to-Cloud solution released by Gao offers data center facilities, intelligent O&M, and DCN as a service, allowing customers to easily relocate and run dedicated compute resources on Huawei Cloud.
Huawei Cloud’s Ascend AI Cloud Service enables training jobs to run non-stop up to 40 days, shortens the fault recovery time to 10 minutes, and increases the linear scalability to 90% (the industry average are 2.8 days, 60 minutes, and 80%, respectively).
Huawei Cloud’s deterministic operations system has been adopted by over 300 global customers, maintaining a strong security record with zero intrusions and zero data breaches.
DeFacto from Türkiye leverages Huawei Cloud’s cloud native solution with Cloud Container Engine (CCE) and streamlines their services.
Huawei Cloud helps Chery to deploy, use, and manage the cloud. Currently, Huawei Cloud nodes in more than 10 countries and regions are providing services for Chery.
NavInfo has adopted Huawei Cloud’s R&D expertise and CodeArts software development pipeline to establish efficient development management standards and efficiency measurement systems.
Kingsoft and Huawei Cloud have collaboratively developed an excellence framework to optimize cost management.
Tencent Music’s Tianqin Lab has developed the MUSELight AI model acceleration framework, utilizing Huawei Cloud’s Ascend AI Cloud Service.
At the end of the summit, Huawei Cloud and global customers jointly released the Enterprise Excellence PRIME Model White Paper. This white paper offers a reference framework for enterprises to leap to excellence with digital and intelligent technologies.
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Artificial Intelligence
Autonomous Mobile Robots (AMR) Market to cross $10 Billion TAM with around 500K AMRs shipment by 2030 – LogisticsIQ
NEW DELHI, Sept. 20, 2024 /PRNewswire/ — The global Autonomous Mobile Robots (AMRs) market is poised for significant growth, driven by increasing demand for automation across various sectors, including logistics, manufacturing, and healthcare. According to the latest market research by LogisticsIQ (5th Edition), Autonomous Mobile Robots (AMR) Market to cross $10 Billion TAM by 2030 with a CAGR of ~30% between 2024 and 2030. We expect the installed base of AMRs to reach 2 million units in 2030.
Download a Free Sample of our report on Autonomous Mobile Robots Market
Key Market Drivers
Increased Efficiency: Businesses are rapidly adopting AMRs to enhance operational efficiency, reduce labour costs, and streamline workflows.Labor Shortages: The ongoing labour shortages in various industries have accelerated the need for automated solutions, making AMRs a crucial investment for companies.Technological Advancements: Innovations in artificial intelligence (AI), machine learning, and sensor technology are making AMRs more capable and reliable.Growing E-Commerce: The rise of e-commerce has created a demand for efficient warehouse management solutions, further boosting the AMR market.Regional Insights
North America leads the AMR market, accounting for the largest share due to the early adoption of automation technologies. Meanwhile, the Asia-Pacific region, especially China is expected to witness the fastest growth, fuelled by rapid industrialization and increasing investments in smart factories. US and China are going to contribute ~40% of this market by 2030.
Industry Applications
Autonomous mobile robots are being utilized in various applications, including:
Warehouse Automation: AMRs enhance inventory management and order fulfillment processes. This industry is expected to lead with more than 75% share by 2030.Manufacturing: Robots facilitate material handling and assembly line operations. Traditionally, it has been dominated by AGVs but are getting replaced by AMRs due to more flexibility and scalability features.Healthcare: AMRs assist in transporting medical supplies, improving patient care and operational efficiency. It is a niche market but high growing area to focus further.Purchase the full report on the Autonomous Mobile Robots Market – Growth, Trends, and Forecast
Top Factors & Challenges in the Autonomous Mobile Robots Market
Top Factors Driving Growth
Increased Demand for Automation: Businesses across industries are increasingly seeking automation to enhance efficiency and reduce operational costs.Technological Advancements: Innovations in AI, machine learning, and sensor technologies improve the capabilities and reliability of AMRs, making them more attractive to businesses.Labor Shortages: Ongoing labour shortages, especially in sectors like logistics and manufacturing, are pushing companies to adopt AMRs to maintain productivity.Growth of E-Commerce: The surge in online shopping requires efficient warehouse and logistics solutions, driving the adoption of AMRs for inventory management and order fulfillment.Improved Safety Standards: AMRs can reduce workplace accidents by taking over hazardous tasks, leading to safer working environments.Customization and Scalability: Many AMR solutions offer customizable features that allow businesses to scale operations according to their specific needs.Top Challenges
High Initial Costs: The upfront investment for AMRs can be substantial, which may deter smaller businesses from adoption.Integration with Existing Systems: Integrating AMRs into current operational workflows and legacy systems can be complex and resource-intensive.Regulatory Compliance: Navigating regulatory requirements and safety standards can pose challenges, especially in highly regulated industries.Limited Awareness and Understanding: Some businesses may lack knowledge about AMR technology and its potential benefits, hindering adoption.Technical Limitations: While technology is advancing, AMRs may still struggle with navigating complex environments or handling unexpected obstacles.Cybersecurity Concerns: As AMRs become more connected, they may be vulnerable to cybersecurity threats, requiring robust security measures.Know more about Autonomous Mobile Robots Market – Top Players, Cost Analysis, Competition, and Customer Expectation
What will you get in this report?
500 Pages and 160+ Exhibits Market ReportRevenue and Shipment data segmented:By form factor (Deck-load, Tugger/Pull, Forklift)By Navigation (Tape/Wire/Magnet, Reflector, QR Codes, LiDAR, Camera, Sensor, Fusion)By Function (Goods to person (G2P), Person to Goods (P2G), Conveying, Piece picking, Towing, Pallet Handling)By Application (Manufacturing, Logistics and Warehousing, Shipping, Delivery, Cleaning, Security, Hospital, Retail)Detailed excel file with 150+ market tables (Revenue and Shipment) including forecast till 2030A bottom-up analysis of Autonomous Mobile Robots Market for 19 countries (United States, Canada, Germany, UK, France, Italy, Spain, Nordics, China, Japan, South Korea, Australia, India, Taiwan, Thailand, Malaysia, Singapore, Indonesia, Phillippines) in 5 regionsIn-depth analysis of 700 companies in the ecosystem with more than 160 company profiles.Focus Group Discussion with 100+ key industry stakeholders across the value chain to collect the first-hand information to validate our analysis. Stakeholders include components and technology providers, system integrators, robot manufacturers (OEM/ODM), robotic software & service providers, and end-user industry verticals. Apart this, study also focuses on different components and integral parts of Autonomous Mobile Robots like Motion Control, Batteries & Chargers, Cameras / Vision Sensor, LiDAR, Sensor Fusion, QR Code and Wireless Communication.2 Analyst Sessions to brainstorm furtherInvestment details excel file with 175+ M&A and ~1000 funding dealsLogisticsIQ™ Exclusive Market Map (700+ Players across more than 15 categories)About LogisticsIQ
LogisticsIQ is a dedicated market research and advisory firm in Logistics & Supply Chain sector, empowering decision makers from top fortune 1000 companies, financial and research institutions, private equity and high potential start-ups with market insights to make better decisions. We enable this by analysing the right mix of the best data, the best research methodologies, and the best industry panel to deliver value to our clients.
Media Contact
Name: Sunny M.Email: [email protected]: +91-952-918-4938
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