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
Gupshup collaborates with Philippines’ leading Neobank Tonik, offers Generative AI chatbot to bring innovation in digital banking
SINGAPORE and MANILA, Philippines, July 2, 2024 /PRNewswire/ — Gupshup, the world’s leading Conversation Cloud today announced its partnership with Tonik Bank, the first digital-only neobank in the Philippines, to develop a state-of-the-art Generative AI chatbot for Tonik’s mobile app. The innovative solution aims to provide Tonik’s customers with instant and accurate answers to frequently asked questions, revolutionizing the way they interact with their bank.
The Generative AI chatbot, powered by Gupshup’s advanced natural language processing (NLP) and machine learning (ML) technologies, is designed to understand and respond to customer queries with human-like precision and empathy. By leveraging the latest advancements in AI, the chatbot can engage in contextual conversations, providing personalized and relevant information to each customer.
Tonik is the first digital bank in the Philippines to leverage Generative AI for customer service. By integrating the chatbot into their mobile app, Tonik Bank aims to provide their customers with instant access to information, reducing wait times and improving overall satisfaction.
“The integration of Gupshup’s ACE LLM into our operations has been truly transformative. We’ve witnessed significant value in its ability to automate routine tasks, elevate customer service, and boost our overall efficiency. This technology has the potential to revolutionize our operations, and we are excited to further explore its capabilities and implement it across our business,” said Sateesh Reddy, Deputy Chief Technology Officer of Tonik Bank.
Since the implementation of Gupshup’s technology, nine out of ten customer queries are now directed through Tonik’s in-app chat feature, where the AI autonomously resolves 75% of the queries without human intervention. This has not only amplified the efficiency of Tonik’s in-house customer care team by 4.3 times but also empowered them to dedicate more time to resolving intricate issues, ensuring that customers receive the personalized support they need.
The Generative AI chatbot solution is expected to generate significant cost savings for Tonik, with an estimated total of over USD 20 million over the next three years.
“Our partnership with Tonik Bank exemplifies the future of BFSI. As the sector evolves, Gen AI will be crucial to deliver seamless, personalized, and efficient customer experiences. Our chatbot solution is designed to do just that, empowering banks like Tonik to focus on what matters most – building strong relationships with their customers,” said Beerud Sheth, Co-founder and CEO of Gupshup.
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The global contextual advertising company enters the Australian market with acquisition of JustEggs, expanding its footprint in the APAC region
SYDNEY, July 2, 2024 /PRNewswire/ — Seedtag, the global leader in contextual advertising, announced today that the company has acquired JustEggs, an Australian-owned creative intelligence business that drives measurable digital solutions for brands and advertisers. The acquisition is a strategic move to support business growth across the APAC region by introducing Seedtag’s proprietary contextual AI technology, Liz, to the Australian market.
Founded in 2013, JustEggs specialises in leveraging its innovative digital solutions to create engaging campaigns that offer true value for brands and advertisers. Starting in July, JustEggs will integrate Seedtag’s privacy-first targeting technologies into its offering to further enhance its advertising solutions, providing more targeted and effective campaigns for its clients through the power of contextual AI. To ensure a smooth integration of both technologies, Seedtag and JustEggs will work closely together while delivering a seamless experience to their partners. JustEggs’ CEO and Founder, Nik Kontoulas, will remain with the company, assuming the role of Managing Director ANZ.
The number of internet users in Australia is expected to exceed 23.3 million by 2025, achieving an impressive internet penetration rate of over 89% – according to Statista. For Seedtag, entering the Australian market was a natural step toward fulfilling its mission of becoming the contextual partner for brands, agencies, and publishers. Australia will now benefit from privacy-first advertising that reaches consumers through their real-time interests at scale. This launch follows Seedtag’s successful market entries in India and Peru in 2023 and Canada in 2024.
For over a decade, Seedtag has been developing its in-house contextual AI technology, Liz, to meet the ever evolving needs of the adtech industry. In 2024, Seedtag was awarded “Best Contextual Targeting Offering” at Digiday Media Awards. The acquisition of JustEggs increases Seedtag’s presence to a total of 17 markets.
“The acquisition of JustEggs is a clear example of Seedtag’s willingness to continue its international expansion into the APAC region,” said Albert Nieto, Co-CEO & Co-Founder of Seedtag. “We are very excited to partner with one of the best teams in our industry to bring contextual intelligence to new heights.”
“Teaming up with Seedtag thrusts us into a fresh era of digital advertising innovation for the ANZ market,” said Nik Kontoulas, founder of JustEggs. “With their proprietary tech and global reach, we’re geared up for success in a cookieless world and beyond. It’s an exciting journey ahead.”
“Australia is a very sophisticated, data and technology-led market, and we have much to contribute to this local digital advertising industry,” said Dal Gill, VP of New Markets at Seedtag. “Following our successful entry into India, this is the second market we have opened in the APAC region. I’m confident that our unique contextual advertising solutions will greatly benefit Australian brands and publishers in achieving their advertising goals while meeting the demand for privacy-first, scalable targeting.”
About Seedtag
Seedtag is the leading contextual advertising company that creates highly impactful and engaging digital ads within relevant premium content, powering targeting and returns for top publishers and the finest brands. The company’s contextual AI, Liz, allows brands to engage with consumers within their universe of interest on a cookie-free basis.
Seedtag was founded in Madrid in 2014 by two ex-googlers who wanted to get the most out of editorial images. Today, it is a global company with more than 600 employees and a significant international presence, with offices in Spain, France, Italy, UK, Benelux, Germany, Mexico, Brazil, Colombia, Argentina, Chile, UAE, Peru, Canada, US, India and Australia.
About JustEggs
Founded in 2013 JustEggs specialize in the convergence of creative, media and data, helping 100+ brands drive customer acquisition and retention.
The mission always remains to evolve the digital ad market with effective and measurable digital ad solutions that drive relevancy for consumers and real world results for retail marketers.
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Artificial Intelligence
Hightouch Introduces Privacy-Conscious Advertising Activation for European Audiences Through EUID
SAN FRANCISCO, July 2, 2024 /PRNewswire/ — Hightouch, the leading Composable Customer Data Platform (CDP), enables European Unified ID (EUID) to help participating advertisers reach audiences in a privacy-conscious way across the open web.
EUID is an industry-wide identity solution pioneered by The Trade Desk, that turns email addresses into a pseudonymous identifier through sophisticated hashing and salting methods. These allow advertisers to recognize users for targeting, frequency management, and campaign measurement while providing transparency and data control to the individual user. The open-source EUID works in the browser environment, providing a reliable alternative to the third-party cookie. It also works across other digital mediums including connected TV, digital audio, and mobile apps.
Hightouch’s integration works by syncing audience segments directly from the brand, publisher, or media network’s cloud data warehouse to The Trade Desk. When participating Hightouch customers create audience segments for digital campaigns, they can activate EUIDs directly within The Trade Desk platform for targeting, frequency management, and measurement. Benefits of Hightouch’s integration between the data warehouse and The Trade Desk include:
Universal opt-outs: Clients can apply field-level governance filters to prevent opted-out IDs from being shared with The Trade Desk.Regional Data Processing: In-transit data is processed using the appropriate regional data center, preventing the movement of data across borders and ensuring regional compliance.Enhanced Addressability: Once data is transferred, advertisers can activate EUID to reach larger addressable audiences across Europe in a privacy-conscious way.Stu Colman, Senior European Director of Identity at The Trade Desk, comments: “The increasing fragmentation in media consumption coupled with the pending deprecation of third-party cookies has pushed advertisers to view identity more holistically across all digital channels, including the web, mobile apps, connected TV and digital audio. Industry-wide identity currencies like EUID provide a significant and overdue upgrade to identity, thereby delivering more precision in targeting, frequency management, and measurement. Hightouch provides its clients with a simple and direct way to activate this new currency so they can benefit from the increased efficiency of their digital advertising on the open internet.”
About HightouchHightouch is the leading Composable CDP that empowers companies to activate their data warehouse to power personalized marketing and business operations. Trusted by leading organizations like PetSmart, Warner Music Group, Calendly, Spotify, and GameStop, Hightouch enables anyone to deliver personalized customer experiences, optimize performance marketing, and move faster by leveraging data across their organization. https://hightouch.com/
About The Trade DeskThe Trade Desk™ is a technology company that empowers buyers of advertising. Through its self-service, cloud-based platform, ad buyers can create, manage, and optimize digital advertising campaigns across ad formats and devices. Integrations with major data, inventory, and publisher partners ensure maximum reach and decisioning capabilities, and enterprise APIs enable custom development on top of the platform. Headquartered in Ventura, CA, The Trade Desk has offices across North America, Europe, and Asia Pacific. To learn more, visit thetradedesk.com or follow us on Facebook, Twitter, LinkedIn and YouTube.
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