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
Logo – https://mma.prnewswire.com/media/1958938/MENARINI_GROUP_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/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-301883109.html
Artificial Intelligence
Slovenian Tourist Board Unveils Innovative Projects to Enhance Tourism and Sports Visibility: Audio Stories, AI-Powered Virtual Assistant, and “Slovenia – Sports Destination” Website
LJUBLJANA, Slovenia, May 28, 2024 /PRNewswire/ — Slovenia is a land of countless natural beauties, cultural treasures, top health and wellness resorts and superb gastronomy, which the Slovenian Tourist Board aims to showcase to visitors in an innovative and attractive way. To achieve this, the Board continually analyzes current marketing trends and develops projects designed to excite tourists, spark their curiosity and inspire them to explore further.
By staying at the forefront of marketing strategies, the Slovenian Tourist Board ensures that the country’s unique attractions are presented in the most engaging and appealing manner possible. The most recent projects to boost Slovenia’s visibility include three new projects: Sounds Like Slovenia, a series of audio stories, an AI-powered virtual assistant named Alma on slovenia.info and the “Slovenia – Sports Destination” website.
More
Meet Alma, an AI-powered virtual assistant
Alma, named after the adventurous traveller and writer Alma M. Karlin, operates using advanced AI technology, filtering content to suit user interests. She sources reliable information from the slovenia.info database and over 50 verified websites of Slovenian tourist destinations and providers. As one of the first AI assistants in Slovenian tourism, and among the few AI assistants integrated in national tourism organizations’ websites in Europe, Alma positions slovenia.info as a reliable source of information and inspiration for international visitors.
More
Slovenia – Sports Destination Website
The Slovenia–Sports Destination website serves as a comprehensive resource for organizing sports activities and events, conferences, rehabilitation and inspiration, available in both Slovenian and English. Sports agencies, clubs, and event organizers can use the portal to connect directly with relevant partners in Slovenia. The website also provides direct contacts for specialized sports agencies and federations, assisting with the organization of preparatory matches and other logistical needs. Information on sports accommodations is also available.
More
Sounds Like Slovenia
Thematic playlists on Spotify and sound stories on slovenia.info provide an immersive audio experience of Slovenia’s landscapes and cultural offerings. Themes are categorized into five categories: the Sounds of Nature, Thrilling Outdoor Adventures, Cities and Culture, Health and Well-Being, and Gastronomy. Crafted for the global digital campaign, the audio list aims to captivate travelers worldwide.
More
Together, these projects demonstrate Slovenia’s dedication to innovation and sustainability in tourism, offering visitors unforgettable experiences in this vibrant European destination with a green heart.
Photo: https://mma.prnewswire.com/media/2422785/Sounds_like_slovenia.jpg
View original content:https://www.prnewswire.co.uk/news-releases/slovenian-tourist-board-unveils-innovative-projects-to-enhance-tourism-and-sports-visibility-audio-stories-ai-powered-virtual-assistant-and-slovenia—sports-destination-website-302156165.html
SHENZHEN, China, May 28, 2024 /PRNewswire/ — On May 26, the closing and awards ceremony of the Huawei ICT Competition 2023–2024 Global Final was held in Shenzhen. This year’s competition attracted more than 170,000 students from over 2,000 universities and colleges across more than 80 countries and regions, making it the largest offline competition since its launch. More than 160 teams, adding up to a total of 470 contestants from 49 different countries and regions, made it through national and regional competitions to reach this year’s global final, held in Shenzhen May 23-26.
After fierce competition, 19 teams from nine countries (Algeria, China, Nigeria, Pakistan, Poland, the Philippines, Tanzania, Türkiye, and Uganda) won the Grand Prizes of the Practice and Innovation Competitions. The Best Social Media Popularity Award was won by a team from Pakistan. The Green Development Award was won by two teams from China and Morocco. The Women in Tech Award was granted to four teams from Kenya, Malaysia, Morocco, and Uganda. And the TECH4ALL Digital Inclusion Award was won by two teams from China and the Philippines.
Zhou Hong, President of Huawei’s Institute of Strategic Research, said: “To make sure everyone can truly enjoy the benefits of digitalization while such technologies are making radical progress, Huawei believes it is crucial to guarantee that digital technologies are accessible to all.”
Stefania Giannini, UNESCO Assistant Director-General for Education, said in a video message:,”UNESCO works to uphold the basic rights and agency of every learner and teacher when using digital technology and AI, and promote an inclusive, equitable, open, and secure digital future for all. Many thanks to our partners like Huawei for their longstanding support.”
Ritchie Peng, President of Huawei’s ICT Strategy and Business Development Department, stated: “ICT is the cornerstone of the intelligent world. Through the Huawei ICT Competition, we aim to provide students with a global platform to compete and exchange ideas.”
On the same day, Huawei also held the ICT Accelerating Education Transformation Summit. At the summit Huawei awarded 24 instructors the title “Huawei ICT Academy Global Most Valuable Instructor.” The awards, given out for the first time this year, aims to show gratitude for the important contributions the instructors have made to talent development, and mark them as role models showing how the brightest minds can grow even brighter. These role models will help drive sustainable development of the ICT talent ecosystem.
The Huawei ICT Competition is an annual contest held by Huawei for global university and college students. Through the competition, Huawei aims to provide students with an international platform for healthy competition and exchange of ideas. Since its launch in 2015, the competition has helped students enhance their ICT knowledge and practical skills, while also increasing their ability to innovate by using new technologies and platforms. The ultimate goal is to advance technological development and facilitate digital inclusion around the world.
Photo – https://mma.prnewswire.com/media/2423048/Closing_awards_ceremony.jpg
View original content:https://www.prnewswire.co.uk/news-releases/winners-of-huawei-ict-competition-20232024-global-final-announced-302156441.html
TAIPEI, May 28, 2024 /PRNewswire/ — NEXCOM, a leading supplier of network solutions, CTOne, a global cybersecurity leader in communication technology, and Vertex, a professional system integrator of 5G private network, join forces for groundbreaking POC targeted to advance 5G private network security within semiconductor manufacturing site framework. Designed to address the specific cybersecurity challenges common in OT networks, collaborative solution offers unparalleled protection, and seamless integration into existing network architectures with minimal disruption to operations during deployment.
Improved Network Security
NEXCOM’s 1U Edge server, the TCA 5170, delivers scalable performance and advanced cybersecurity features, empowering manufacturers with robust OT network protection. Leveraging cutting-edge technologies, the TCA 5170 accelerate encryption and decryption processes, ensures authentication and real-time threat detection, safeguarding private networks against evolving cyber threats. Its scalability makes it ideal for deployments of all sizes, from smaller production lines to semiconductor giants, providing comprehensive security solutions for diverse industrial needs.
More Visibility, Easier Management
The integrated solution simplifies the management of complex OT networks, enabling IT teams to efficiently monitor and manage network security while optimizing resource utilization. CTOne’s virtualized private 5G security software, installed on TCA 5170 and deployed at strategic points at the semiconductor manufacturing site, integrates seamlessly across IT and CT networks to deliver full visibility with real-time monitoring of data traffic. Combined with CTOne’s built-in 5G protection capabilities, the solution enable immediate interception and isolation of threats while supporting a Zero Trust strategy.
“This collaboration has been pivotal in delivering a comprehensive cybersecurity solution for semiconductor manufacturing sites,” said Ming-Yang, Yi, senior manager of AMEA business development group of CTOne. “By integrating our advanced 5G visibility and security capabilities with NEXCOM’s TCA 5170, we’ve created a robust solution that enhances data protection and optimizes operational efficiency of private 5G networks.”
“Working alongside NEXCOM and CTOne has allowed us to deliver a truly comprehensive cybersecurity solution for private 5G network,” said Willis Fu, Technical Director at Vertex. “Bringing together NEXCOM’s TCA 5170 and CTOne’s Mobile Network Security solution ensures seamless protection of the private 5G network, providing our end customer with peace of mind and confidence in their operations.”
“The TCA 5170 is a compact 1U server that offers different configurations and scalable performance, allowing our ecosystem partners to easily adapt and run their applications for deployments of all scales,” said Jennifer Lan, Sales & Marketing Director of Network & Communication Solutions at NEXCOM. “Our successful collaboration with CTOne and Vertex underscores our commitment to providing top-tier security and operational efficiency for our clients.”
Read full Case Study: Security-Solution-to-Protect-Private-Networks-at-Semiconductor-Facilities.pdf (nexcom.com)
This joint solution can be experienced firsthand at upcoming exhibitions:
May 29 – May 31, 2024, CommunicAsia 2024, Singapore, Singapore EXPO, Hall 4, booth 4E3-14June 26 – June 28, 2024, COMNEXT, Japan, Tokyo, Tokyo Big Sight, South Hall, Booth 9-14About NEXCOM
Founded in 1992 and headquartered in Taipei, Taiwan, NEXCOM integrates its diverse capabilities and operates six global businesses, including the Network and Communication Solutions (NCS) unit. NCS focuses on the latest network technology and helps to build reliable network infrastructure, by delivering professional design and manufacturing services for customers all over the world. NCS’s network application platform is widely adopted in Cyber Security, Load Balancing, 5G uCPE, SD-WAN, SASE, Edge Computing, OT Security, Storage, NVR, and other network applications for businesses of all sizes.
Photo – https://mma.prnewswire.com/media/2423000/3__End_to_End_Cybersecurity_Solution_to_Protect_Private_Networks_at_Semiconductor_Facilities.jpg
View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/nexcom-ctone-and-vertex-join-forces-to-enhance-private-network-security-302156384.html
-
Artificial Intelligence4 days agoTitans of Tech: GP Bullhound releases its annual report on the European tech ecosystem
-
Uncategorized4 days agoGienTech Hosted the “2024 GienTech Digital Transformation Conference” to Promote Overseas Collaborative Ecosystem Development
-
Uncategorized4 days ago
Hyreo ushers in a New Dawn for Recruitment Technology with Hyreo Labs
-
Artificial Intelligence4 days agoBybit Web3 Announces Upcoming IDO for Aperture Finance, Simplifying Web3 Finance
-
Artificial Intelligence6 days agoHONOR Unveils Four-Layer AI Architecture and Forges Ahead with Google Cloud for More AI Experiences at VivaTech 2024
-
Artificial Intelligence3 days agoOverseas Expansion Strategy of K-OTT Introduced in France, KOCCA holds the ‘2024 Korea-France Content Forum’
-
Artificial Intelligence4 days agoNorthern Data Group’s Peak Mining, announces purchase of a second 300MW data center location in Corpus Christi, Texas
-
Artificial Intelligence4 days agoIoT Node and Gateway Market worth $604.7 billion by 2029 – Exclusive Report by MarketsandMarkets™
