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

Published

10 months ago

July 23, 2023

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

Compact Solutions, Mighty Results: Cervoz Unleashes the Power of Edge Computing

Published

21 mins ago

May 20, 2024

CISION (PR Newswire)

compact-solutions,-mighty-results:-cervoz-unleashes-the-power-of-edge-computing

TAIPEI, May 20, 2024 /PRNewswire/ — Cervoz Technology, a leader in industrial-grade storage, memory, and expansion solutions, is powering the evolution of edge computing with its innovative solutions.

In today’s data-rich landscape, businesses rely on insights from IoT devices. With advancements in AI and 5G, data volumes surge, straining traditional cloud computing with bandwidth and latency issues. Edge Computing emerges as a solution, processing data at its source for real-time insights crucial for applications like digital twins, autonomous vehicles, and smart healthcare.
What is Edge Computing?
Edge Computing is a decentralized IT architecture that processes data near its origin, often at the network’s edge. This approach divides tasks from central data centers to edge devices and nodes. It enables faster, deeper insights and enhances responsiveness, improving speed and reducing latency compared to centralized clouds. Typically, an Edge Computing system comprises three layers: device, edge, and cloud.
The Device Layer
The device layer, situated closest to the physical world, comprises endpoint devices such as sensors, controllers, and cameras, among others. The layer prioritizes data collection and initial processing for real-time response and efficiency. It requires highly reliable, compact, and energy-efficient components. Cervoz’s M.2 2230 (A+E key /B+M key) NVMe SSDs and DDR4 SO-DIMM modules optimize this setup with fast data access and efficient storage in space-saving designs. They operate reliably across a wide temperature range (-40°C to 85°C) and feature additional conformal coating and anti-vibration filling for enhanced performance in harsh environments.
The Edge Layer
The edge layer, composed of edge servers and gateways, serves as a crucial link between device-layer data sources and cloud-based operations. It is designed for extensive data handling, filtering, and analytics, emphasizing quick operations and real-time responses to minimize reliance on remote data centers. For optimal performance, components must manage high processing loads with minimal latency and maximum stability. NVMe SSDs boasting PCIe Gen3 or higher, such as the Cervoz NVMe PCIe Gen3x4 SSD, with compact M.2 form factors, advanced DRAM cache buffer, and LDPC ECC technology, are perfectly suited for the edge layer. These SSDs enable efficient directory and error correction during high-speed data transfers, thus enhancing data accuracy and reliability.
The Cloud Layer
The cloud layer requires intensive processing and long-term storage, performing analytics, operating AI and machine learning, and managing extensive data systems across various edge locations. It demands high-performing and reliable components. Cervoz NVMe PCIe Gen4x4 SSDs excel with Read/Write speeds of up to 7,100/6,190 MB/s and 4K random IOPS up to 1,000K, with aluminum heatsinks and thermal throttling for overheating issues. DDR5-5600 DRAM boosts this setup with high data throughput and efficient power use, satisfying rigorous computational needs.
Interlayer Connectivity
Reliable, low-latency network connectivity is crucial as data flows between the device layer, edge, and cloud. Cervoz 10GbE Low-Profile Ethernet Card provides high-speed, stable wired connections in high-bandwidth, low-latency environments. Additionally, the new PCIe Compact Low-Profile Ethernet Card is ideal for narrow edge device enclosures. For areas where wiring is impractical, M.2 Wi-Fi cards offer essential wireless flexibility. These connectivity options ensure a solid foundation for seamless data management across all layers.
Cervoz offers comprehensive solutions to enhance edge computing capabilities. From compact NVMe SSDs and DRAM modules, to advanced modular expansion cards, enabling seamless integration, optimized performance, and unmatched reliability in edge computing deployments.
About Cervoz
Based in Taiwan, Cervoz Technology boasts almost twenty years of expertise in developing and providing industrial-grade storage, memory, and expansion solutions across a myriad of global industrial sectors.
ContactsSales: [email protected]
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Artificial Intelligence

Team Exponentia.ai UK attended the AWS summit in London

Published

21 mins ago

May 20, 2024

CISION (PR Newswire)

Team Exponentia.ai UK celebrates Sanjay Kumar’s insightful session at the AWS summit in London
LONDON, May 20, 2024 /PRNewswire/ — Sanjay Kumar, Head of Exponentia.ai in UK & Europe, delivered an impactful presentation on Driving Manufacturing Innovation through AWS Analytics & AI. The recently concluded AWS Summit took place on the 24th of April in ExCeL, London.

Sanjay shared the stage at Theatre B with Adrian Pinder from DS Smith and Ahmed Raafat from AWS, captivating the audience with insights and experiences from Exponentia.ai’s collaboration with DS Smith.
During the session, Sanjay Kumar highlighted Exponentia.ai’s impressive use cases and case studies, including the Data Factory and Procurement Spend Analytics (PSA) projects undertaken in partnership with DS Smith. These initiatives demonstrated Exponentia.ai’s commitment to leveraging the AWS ecosystem to drive operational efficiency and business growth in the manufacturing sector.
The Exponentia.ai team seized the opportunity to engage with industry peers, partners, and friends, while also exploring the latest innovations showcased at the summit. Their participation in various sessions and visits to innovative booths further enriched their understanding of industry trends and best practices.
Reflecting on the event, Sanjay Kumar expressed his enthusiasm, stating, “The AWS Summit in London provided an excellent platform for us to showcase our expertise in manufacturing analytics and AI. The overwhelming response from attendees reaffirms the value of our solutions in driving innovation and transformation across industries and our commitment to deliver value to our customers through data. We look forward to continuing our collaboration with AWS and our partners to deliver impactful outcomes for our clients.”
The AWS Summit London 2024 marked a significant milestone for Exponentia.ai, reinstating its commitment to excellence and innovation in the field of AI and analytics. As the team eagerly anticipates future events, they remain dedicated to empowering businesses with transformative technology solutions.
For more information about Exponentia.ai and its innovative offerings, please visit www.exponentia.ai.
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Artificial Intelligence

Clarivate Launches AI-Enhanced Solution to Accelerate Trademark Watching

Published

21 mins ago

May 20, 2024

CISION (PR Newswire)

Providing faster and more accurate answers to critical business questions
LONDON, May 20, 2024 /PRNewswire/ — Clarivate Plc (NYSE: CLVT), a leading global provider of transformative intelligence, launched the first publicly available version of Trademark Watch Analyzer today at the 2024 International Trademark Association Annual Meeting. As the next-generation trademark protection solution enhanced by artificial intelligence (AI) and cloud technology, this solution combines Clarivate global trademark and case law data, in-house IP expertise, and cutting-edge AI technology. It will provide faster and more accurate answers to critical business questions by automating key trademark watching tasks and intelligently prioritizing result sets.

Trademark Watch Analyzer connects users to trademark datasets in 258 countries and territories across 191 official trademark registers, as well as data from 7+ million trademark litigation cases. This content is harmonized and connected through AI algorithms which query, connect and mine both datasets delivering advanced insights in supported watch products. This revolutionizes the way trademark watch results are delivered, so that clients can rank results based on their chance of success/opposition.
According to data from SAEGIS®, a CompuMark™ trademark solution from Clarivate, the number of trademark applications filed globally each year has more than doubled since 2014. With over one million new trademarks added to trademark registers around the world each month, the risk of infringement has never been greater, making vigilance of trademark applications essential to protect and grow strong brands.
Gordon Samson, President, Intellectual Property, Clarivate, said: “As the global business landscape grows more complex, trademark professionals are faced with challenges including more data, less context and shorter deadlines. Our advanced AI-driven solution enables clients to confidently monitor their trademarks anywhere in the world, with global monitoring and automated alerts, while also saving time, costs and critical resources. The launch of the Trademark Watch Analyzer is the latest example of our Think forward™ promise — connecting clients to trusted intelligence to ensure an IP-empowered tomorrow.”
With a more intuitive design and user interface, Trademark Watch Analyzer will enable clients to have a much-improved user experience as they work with their results. The navigation will be based on the same architecture as the Brand Landscape Analyzer launched in 2023, providing clients with a more cohesive experience within the Clarivate product suite.
Find out more about Trademark Watch Analyzer here.
About ClarivateClarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit www.clarivate.com
Media Contact: Jack Wan, External Communications Director [email protected]
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