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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

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10 months ago

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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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Appian Named a Leader in the 2024 Gartner® Magic Quadrant™ for Process Mining Platforms Report

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2 hours ago

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May 3, 2024

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LONDON, May 3, 2024 /PRNewswire/ — Appian (Nasdaq: APPN) today announced it has been named a Leader by Gartner in its 2024 Magic Quadrant for Process Mining Platforms report. The report evaluated 18 vendors and their product offerings. For more information, download a complimentary copy of the Gartner Process Mining 2024 report. 

Gartner defines Process Mining platforms as tools that deliver visibility and insights to technology innovation leaders that enable smart decision making and strong performance on an organisation’s critical priorities. Features that make Appian a leader in Process Mining, include:
Faster data prep that eliminates complex transformation with always-ready data from multiple sources.Automated process analysis and intelligent recommendations for where and how to take action.A low-code experience for measuring, monitoring, and optimising process performance—all within one platform.”We believe that Appian’s recognition in the Gartner Process Mining Platforms Magic Quadrant underscores our dedication to process excellence. Through Process HQ, we integrate data fabric, process mining, machine learning, and generative AI to streamline manual data prep, enabling businesses to gain insights swiftly and implement improvements easily,” said Michael Beckley, CTO and Founder of Appian. “Our unified approach merges Process Mining with AI-driven process automation, setting a new standard for efficiency and intelligence.”
Business users need greater visibility into the full breadth of their enterprise data and processes in order to maximise operational efficiency and strategic decision-making. By combining the latest technologies in data fabric, process mining, machine learning, and generative AI, Process HQ helps monitor and improve every business process built on Appian. Process HQ makes it easy to reduce costs, risks, and delays, improve compliance, and drive better business outcomes, without the need for costly and time-consuming data collection efforts.
Appian is now an industry leader across its value proposition to Design, Automate, and Optimise the most complex business processes. In addition to today’s announcement, Appian was named a Leader in the 2023 Gartner® Magic Quadrant™ for Enterprise Low-Code Application Platforms report, and was ranked #1 for the Business Workflow Automation with Integration Use Case in the 2023 Gartner® Critical Capabilities for Enterprise Low-Code Application Platforms (LCAP) report.
To access the report and to learn more about Appian’s positioning, visit https://ap.pn/3y2ClZy. Register for our upcoming webinar Process Intelligence Made Easy: The Key to Better Business Decisions on June 20, 2024 at 12pm EST to discover how Process HQ can improve business processes.
Gartner disclaimerGartner does not endorse any vendor, product or service depicted in our research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner research organisation and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. GARTNER is a registered trademark and service mark of Gartner and Magic Quadrant is a registered trademark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and are used herein with permission. All rights reserved.
About Appian
Appian is a software company that automates business processes. The Appian AI Process Platform includes everything you need to design, automate, and optimise even the most complex processes, from start to finish. The world’s most innovative organisations trust Appian to improve their workflows, unify data, and optimise operations—resulting in better growth and superior customer experiences. For more information, visit appian.com. [Nasdaq: APPN]
Follow Appian: LinkedIn, X, and X (UK).
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Artificial Intelligence

Innodisk Introduces iCAP Air: Advancing Air Quality Management through Autonomous Decision-Making

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4 hours ago

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May 3, 2024

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TAIPEI, May 3, 2024 /PRNewswire/ — Innodisk, a global leader in AI solutions, has taken a pivotal step forward in environmental sustainability with the launch of its latest innovation, the “iCAP Air” air quality management solution. This solution empowers businesses worldwide to enhance air quality, sustainability, and human health. Additionally, business can benefit from monthly AI-generated air quality data report, providing valuable insights for informed decision-making.

Leveraging its expertise in edge computing and software and hardware integration, along with the expertise of its subsidiary Sysinno in air quality detection, Innodisk has achieved the development of the “iCAP Air” air quality management solution. This solution integrates advanced technology, including the innovative “iAeris7” air quality detector from Sysinno, to deliver accuracy in detecting temperature, humidity, fine suspended particles (PM2.5), suspended particles (PM10), carbon dioxide (CO2), formaldehyde and total volatile organic compounds (TVOC). It can also be customized to detect NO2, SO2, CO, NH3, and other air factors. At the same time, the iAeris7 device is known for its reliability, patented technology, and various international certifications, including those from SGS and FCC/CE/RoHS/NCC/BSMI.
The solution also includes the “iCAP Air Server,” designed to manage large-scale deployment and data from up to 100 air quality detectors, ensuring seamless integration and efficient operation, even in complex environments. Additionally, iCAP Air provides a user-friendly air quality management platform, enabling organizations to monitor air quality in real-time via a mobile app or internet browser, receive automatic alerts, and optimize air purification or exhaust ventilation system.
iCAP Air is a comprehensive solution that simplifies air quality management for users. It is tailored for medium to large-sized sites or densely populated, enclosed spaces such as medical institutions, smart manufacturing facilities, public transportation hubs, indoor parking facilities, and department stores. Innodisk’s “iCAP Air” air quality management solution represents a milestone for all businesses committed to leveraging technology for the greater good of air quality and society.
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Artificial Intelligence

Bitrue expands Bitcoin Runes Offerings with GPTV Listing and Staking Options

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May 3, 2024

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VICTORIA, Seychelles, May 3, 2024 /PRNewswire/ — Leading digital asset exchange Bitrue continues its community-driven approach with the listing of a new Bitcoin Runes token, GPTV•AI•PEPE•KING (GPTV). This follows the recent addition of several other Bitcoin Runes tokens to the platform, including SATOSHI•NAKAMOTO (SATOSHI), LOBO•THE•WOLF•PUP (LOBO), RSIC•GENESIS•RUNE (RSIC), and DOG•GO•TO•THE•MOON (DOG). Trading for the GPTV/USDT pair commenced on April 30th, 2024.

What is GPTV?
GPTV is the native token of AI PEPE KING, a project claiming to be the “largest AI Meme Community” with a presence on both the Polygon (AIPEPE) and Bitcoin Runes (GPTV) blockchains. Notably, AI PEPE KING secured a $10 million investment to develop AI-powered customer service tools leveraging the ChatGPT technology. Additionally, they are building a “Dream Lottery” system. Revenue generated from these products is earmarked for buybacks and burns of both AIPEPE and GPTV tokens, potentially influencing their long-term value.
Staking Opportunities with Attractive Yields
Bitrue is also offering users staking opportunities for those holding BTR, AIPEPE, RSIC, or DOG tokens. By staking their holdings, users can earn rewards in GPTV, with estimated annual percentage yield (APY) varying on the staked token, with BTR offering 22.15%, AIPEPE at 23.18%, RSIC boasting a higher 31.37%, and DOG coming in at 23.62%. These yields present a potentially lucrative opportunity for users to grow their cryptocurrency holdings, but also come with financial risk and the potential for investment to return much lower yields.
Bitrue’s Focus on Community Engagement
The listing of these Bitcoin Runes tokens is a testament to Bitrue’s commitment to its user base. The decision to add these tokens stemmed from a community poll conducted through an X poll on Bitrue’s X account. This highlights the exchange’s dedication to incorporating community feedback into its decision-making process, fostering a sense of collaboration and shared interest.
With the addition of GPTV and the introduction of staking opportunities, Bitrue continues to expand its offerings for users interested in the burgeoning world of Bitcoin Runes tokens. The exchange’s focus on community engagement further strengthens its position as a platform that prioritizes user input and satisfaction.
About Bitrue
Launched in July 2018, Bitrue is a diversified digital asset exchange that supports trading, loans and investments. Bitrue aims to utilize blockchain technology to bring financial opportunities to everybody regardless of their location or financial position. With offices in Asia and Europe, the business continues to develop new features at a rapid speed to fully service the new wave of the digital economy. More information is available at Bitrue’s website.
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