Gibson Records Artist GHOST HOUNDS Release Single/Video for "Last Train To Nowhere"; New Album 'First Last Time' Out July 28
Listen to the powerful new single “Last Train To Nowhere” out today, from GHOST HOUNDS. The rock and blues-fueled song comes ahead of the group's fourth studio album, FIRST LAST TIME, out July 28 on Gibson Records; pre-save the album HERE. The explosive song will make its global TV debut during the premiere episode of Taylor Sheridan’s (creator of "Yellowstone") new TV series “Special Ops: Lioness”--featuring Nicole Kidman, Morgan Freeman, and Zoe Saldana--airing on Sunday, July 23 on Paramount+. “Last Train To Nowhere” sets the tone for a pivotal moment during the show, fueling the scene’s intensity throughout. Listen to “Last Train To Nowhere” HERE. https://found.ee/lttnsingle and watch/share the new performance video, directed by Jay Arcansalin, HERE. “Last Train To Nowhere” comes to life with explosive guitar riffs, complemented by ineffable vocals from lead singer Tré Nation as he tells the story of a man confronting the fact that he lacks purpose, a legacy, and a moral compass. These themes of desolation and unfulfillment are explored further on the band’s forthcoming album, FIRST LAST TIME. The 10-track album is a masterclass in blues rock, with the band feeling invigorated after touring with The Rolling Stones in 2022. On the new song, guitarist/songwriter Thomas Tull explained, “That’s one of my favorite songs that I've ever written. I wrote it on an acoustic, and the music just came together. Lyrically, it’s about a guy who’s reflecting on his life. He's gotten older, and he’s had a varied career, if you want to call it that. He talks about laying bricks and doing all these odd jobs. He’s not someone who worked at a company or was a teacher or a fireman that can say, ‘This is what I did with my life's work.’ This guy's life's work was whatever work he could get. And he never settled down, never had kids. So, he's thinking about that last train ride, or whatever metaphor you want to use there, and he's starting to think, ‘I'm not sure I'm gonna leave any legacy at all.’ And what does that feel like? That’s the story of that song.” Ahead of the album release, GHOST HOUNDS will be performing on Saturday, July 15 at Harley-Davidson’s Homecoming Festival, which celebrates the iconic motorcycle brand’s 120th anniversary. The band will be performing at the Milwaukee festival alongside legendary rock acts including Green Day, Foo Fighters, Joan Jett & the Blackhearts, and more. Catch GHOST HOUNDS’ set on Saturday, July 15 at 3pm at Veterans Park in Milwaukee, WI. On Thursday, July 27, GHOST HOUNDS will celebrate with an official album release party and performance at the Gibson Garage in downtown Nashville. Stay tuned for more tour dates to be announced soon. FIRST LAST TIME, Full Album Tracklisting: 1. “Last Train To Nowhere” 2. “Dirty Angel” 3. “First Last Time” 4. “Make It Shake” 5. “Let’s Sleep On It Together” 6. “Here No More” 7. “Love You Too Hard” 8. “Chasing You” 9. “Hot Dog” 10. “Country Roads” Hailing from Pittsburgh, PA, GHOST HOUNDS plays blues-inspired rock in such a way that proves that the genre is not only alive but thriving for the next generation of rock fans. GHOST HOUNDS--features Thomas Tull (guitars/songwriting), Johnny Baab (guitars), Bennett Miller (bass), Blaise Lanzetta (drums), and is fronted by the powerful lead vocals of singer Tré Nation--have released three studio albums to date. Their debut Roses Are Black (2019) generated millions of streams and received acclaim from Billboard, American Songwriter, and more. In 2021 the band released their sophomore album, A Little Calamity, showcasing the band’s classic rock chops, that included the infectious track and hit single, “Good Old Days.” Soon after came the band’s 2022 album, You Broke Me, a perfect testimony to GHOST HOUNDS’ ability to blend classic blues rock with modern influences. The band has had plenty of time to refine their sound on the road, having supported legendary acts including The Rolling Stones, ZZ Top, Garth Brooks, and Bob Seger on major global tours. Currently, the band is gearing up to release their fourth album, FIRST LAST TIME which will be released on July 28 via Gibson Records--the music label which delivers guitar-driven music to the forefront of culture--in partnership with Firebird Label Services for distribution.
Dusit Thani Maldives enhances guests journeys with luxurious seaplane lounge experience
Dusit Thani Maldives, a luxury Thai-inspired resort on Mudhdhoo Island in Baa Atoll, has elevated its arrival experience by opening an exclusive seaplane lounge at the Trans Maldivian Airways (TMA) terminal at Velana International Airport in Malé. Designed to deliver unmatched comfort and tranquillity to guests as they anticipate their connecting flight to the island, the expansive, air-conditioned lounge is tastefully furnished with luxurious seating spaces, floor-to-ceiling windows, and elegant, modern decor embodying Maldivian serenity. In line with Dusit Thani Maldives' dedication to delivering unparalleled experiences, the seaplane lounge offers exclusive refreshments, gourmet snacks, and a variety of beverages, plus complimentary high-speed Wi-Fi, electronic device charging stations, and a dedicated children's play area to ensure a relaxed atmosphere for families and couples alike. Dusit Thani Maldives' collaboration with TMA, the globe's largest seaplane operator, ensures guests can enjoy prompt and smooth transfers the moment they touch down in the Maldives. Resort-assigned airport representatives are present to assist with luggage and navigate guests through the transfer process, so they can focus on enjoying the travel experience. “Our complimentary Dusit Thani Maldives seaplane lounge has been meticulously crafted to provide an extraordinary experience right from the moment our guests step foot in the Maldives, and we are thrilled to present it as part of our unique offerings,” said Mr Reinhold Johann, General Manager, Dusit Thani Maldives. “Aligned with our unwavering commitment to providing top-tier service, we hope to curate an unforgettable journey for each guest, leaving them with cherished memories that will last a lifetime.” The seaplane lounge marks the latest addition to Dusit Thani Maldives' constant endeavours to elevate its guest experience. With its deluxe villas, world-class overwater dining, and spa treatment rooms nestled amidst palm trees, the resort continually raises the bar for luxury travel in the Maldives. For further information or reservations, please visit https://www.dusit.com/dusitthani-maldives/ or Tel: +960 660 8888
Brazil crowned world’s best FIFA esports nation for the second time
Emotions soared as Brazil cemented themselves in history as the best FIFAe nation in the world on 14 July. With national pride on the line, 24 nations competed in the 2v2 format for a total prize pool of USD 1 million from 11 to 14 July. The FIFAe Nations Cup 2023™ presented by Gamers8 came to a dramatic finish after four passionate days of competition. Brazil, composed of PHzin, Resende and PauloNeto999 walked away as back-to-back FIFAe Nations Champions lifting the trophy for the second year in a row. Led by Phzin, Brazil is the first nation to repeat as FIFAe Nations champions and the first nation to win the pinnacle event twice. Out of 86 Member Associations competing in this year’s FIFAe Nations Series, the best 23 qualified alongside the host nation Saudi Arabia, while Brazil rose above the rest of the competition. In addition to taking home USD 300,000 out of the total prize pool of USD 1 million for this competition, the team lifted the unique trophy as repeat champions. “PHzin, he is a star; I’ve been saying this. He’s the best player in the world and he’s showing us again this season,” said Gabgol, the coach of Brazil. “He’s super special, we are glad he plays for Brazil.” FIFA Legend and former professional football player Sami Al-Jaber was also in attendance to witness the action live in person: “It’s incredible to see Saudi Arabia host the FIFAe Finals and I’m proud to see so many countries from across the world attend. This is a huge step for the Saudi Arabian community and for the growth of esports and football alike in the kingdom and I’m excited to see where it goes from here,” said Sami Al-Jaber, former captain of the Saudi Arabian national football team.
DHL Express officially opens Incheon Gateway after €131 million (KRW 175 billion) expansion
Seoul, September 5 2023: DHL Express, the world's leading international express service provider, has commenced the full-fledged operation of Incheon Gateway after it invested €131 million (KRW 175 billion) to expand the Gateway in 2019. The investment is DHL Express’s largest in South Korea to date, making Incheon Gateway the largest gateway in the Asia Pacific. The expansion aims to address the increasing air cargo demand at the Gateway, as a result of growing overseas trade in South Korea and increase in international express import and export with Asia-Pacific countries, including Singapore, Japan, China, Australia, and Taiwan. Sean Wall, Executive Vice President of Network Operations and Aviation, Asia Pacific, DHL Express, was present to commemorate the opening of the new Incheon Gateway. He said, "We are handling more cargo in South Korea in recent years, and we expect the demand to continue on its upward trajectory. Between 2011 and now, the transit cargo handling volume we handled in the country grew more than threefold. The opening of the expanded Incheon Gateway arrives at a right time as it plays an important role to facilitate regional and intra-Asia trade, particularly for the Northeast Asian region, including Dalian, Qingdao, Wuxi, Ulaanbaatar, and Guam." The enhanced Incheon Gateway now boasts a gross floor area of 59,248 square meters – thrice the size of the previous Gateway at 19,946 square meters. The handling capacity is also boosted by over 3.5 times to reach 28,400 pieces per hour. The Gateway houses a 5.5 kilometers-long conveyor belt and 19 automated X-ray inspection machines to ensure shipment contents are safe and compliant. Moreover, Incheon Gateway is a pivotal logistics facility, connecting global DHL hubs and gateways through seven dedicated DHL aircraft and 40 aircraft from partner airlines. This can address the ever-growing transit shipment demand in the Northeast Asian region. To process import and export shipments faster and more efficiently, the Incheon Gateway features a fully automated sorting and handling system. In particular, an automated document and small parcel sorter can efficiently process over 10,000 parcels an hour, significantly enhancing the handling speed and operations competency. As a result, more than 30 minutes of delivery time for imported goods is saved. To minimize greenhouse gas emissions, the facility is partly powered by solar energy. A 1-megawatt solar power generator is installed – spanning the entire rooftop area (5,700 square meters) of the Gateway. The solar generator can produce energy that covers roughly 30% of the facility’s consumed energy, thus reducing around 650 tons of carbon emissions annually. This marks the first instance among cargo terminals within Incheon International Airport to use solar energy. ByungKoo Han, Country Manager of DHL Express Korea, said, "The Incheon Gateway serves as a strategic facility that connects South Korea and the Asia Pacific region to the world. Since its initial opening in 2009, the handling volume of import and export at Incheon Gateway has increased by more than 90% in 2022. With this expansion, we are confident that we can adeptly manage the surge in shipment volume and cater to the increasing demand for international express delivery over the coming decade." South Korea is the world's sixth largest e-commerce market. The larger Incheon Gateway will also now better support Korean cross-border e-commerce companies to grow in overseas markets.
Metal and Monsters New Episode Features Rex Brown of Pantera, Dug Pinnick of King's X, and Legendary Filmmaker Roger Corman
Gibson TV, the iconic American instrument brand’s award-winning, worldwide online network--features original series about music and culture from the world’s best storytellers. Gibson TV has premiered the third episode of the original series titled “Metal and Monsters”--the network’s first show dedicated to heavy metal and monster culture. Throughout “Metal And Monsters,” viewers are treated to different segments that explore the worlds of music, film, and tales from the dark side. All Gibson TV original shows are streamed for free on Gibson.com HERE; subscribe to Gibson TV on YouTube and be notified when new episodes become available HERE. Gibson TV’s “Metal and Monsters” returns with host Count D for this “Texas Sized” new episode featuring iconic bass players and longtime friends Rex Brown (Pantera) and Dug Pinnick (Kings X) as they reunite for an evening of stories surrounding friendship, music, and their Texas roots. Legendary filmmaker, director, producer, and actor Roger Corman is featured in special segment with an intimate interview reflecting on his early career. “It was great reuniting with my old friend Dug Pinnick for this episode of ‘Metal and Monsters’,” says Rex Brown of Pantera. “We sat and talked for hours that day, and you could really feel the love in that old theater! It's so special to my heart that we did this off-cuff. Just two friends sitting and reminiscing about life and music. What a wonderful night!” In the segment “Tunes From The Crypt,” “Metal and Monsters” host Count D details the history of the landmark album “Leprosy” from Florida death metal legends Death. Viewers also have the chance to win several different Death prizes including CDs, vinyl, t-shirts, Halloween masks and two exclusive Death skateboards from our friends at Check Your Head Skateboards. In the segment “Terror Trek,” the monster squad heads to Las Vegas to visit KISS WORLD at the Rio Hotel to explore Gene Simmons iconic personal collection of KISS memorabilia. Viewers are also treated to guest appearances from Brent Fitz (drums), and Todd “Dammit” Kerns (bass) from Slash featuring Myles Kennedy and The Conspirators, and KISS drummer Eric Singer. Known as “The King of Cult” and “The Pope of Pop Cinema,” famed director and producer Roger Corman is featured in the historical segment “Exhumed From The Tomb.” Not only is Roger responsible for films including The Raven, Little Shop of Horrors, The Fast & The Furious and Death Race 2000, but he is also credited for launching the careers of film legends Jack Nicholson, Ron Howard, Sylvester Stallone, Martin Scorsese, and Francis Ford Coppola.
Porsche Korea Presents the Global Artwork 'Dream Big' as Public Art Exhibition at Lotte World Tower World Park
Seoul - Porsche Korea (CEO Holger Gerrmann) announced the opening of the ‘911 Dream Park’ at Lotte World Tower World Park in Songpagu, Seoul, to celebrate the 60th anniversary of the brand's iconic model 911 with the large-scale global artwork sculpture ‘Dream Big’. The exhibition is part of a public art project that brings art closer to the citizen's daily life, featuring graphic artist Chris Labrooy's ‘Dream Big’ which is inspired by Porsche’s ‘911’ and a childhood ‘Dream’. After its worldwide exhibition in Miami, Singapore, the United Kingdom, France and China, the ‘Dream Big’ exhibition will have its highlight finale in Korea, held until September 3rd. Paying homage to the artist’s childhood dream, ‘Dream Big’ depicts a larger-than-life figure in a racing driver's helmet playing with a ‘Porsche 911 Carrera 4 Coupé’, comparatively the size of a toy figure. Along with Porsche 911 which has become a timeless icon over the past 60 years, Porsche will share its inspiration with a wider audience as a brand that strives to make dreams come true. Alongside the 'Dream Big' exhibition, Porsche Korea offers various programs at the '911 Dream Park'. The ‘Dream Racing Zone’ allows visitors to enjoy the fun of driving in Go-karts and receive a Porsche Dream Racing license. Additionally, the 'Dream Station' has been set up to show visitors the history of the past eight generations of the Porsche 911 since its introduction in 1963 and experience the brand lifestyle. Porsche Korea CEO Holger Gerrmann stated, "This public art exhibition carries even deeper meaning since it delivers the values of ‘dream’ and its ‘realization’ in the 60th anniversary of the 911 and shares it with the Seoul citizens in this unique setting defying size and perception." He also added, “We hope the “Dream Big” Sculpture sparks the interest of many and inspires to dream." On the evening of the first day of the exhibition, the 25th, a special event will be held to commemorate the opening of the '911 Dream Park'. The students from 'Porsche Dream Up', a social contribution program for talented children in sports and arts that marks its sixth year, will attend and perform a celebratory recital with clarinet and cello, as part of their journey of realizing their dream. Souvenirs will be given to a total of 100 people, including invitees from Porsche Korea's official Instagram and on-site first-come-first-serve viewers. As a brand for those who dream, Porsche has persistently launched a global art series to engage and inspire fans in new ways. With the start of ‘Porsche Dreamers. On.’ in 2021, Porsche Korea has been supporting the dreams and talents of emerging artists as well as expanding opportunities for citizens to enjoy public art. In addition, Porsche Korea plans to support more dreams through ongoing social contribution campaigns. Meanwhile, Chris Labrooy, a 3D graphic artist from Scotland, presents works that combine objects from the real world with surrealism. Labrooy, an actual Porsche fan and owner, has created iconic works such as 'Palm Springs Porsche 911', which features 12 Porsches floating in a swimming pool, and '996 Swan', which commemorates the 20th anniversary of Porsche China, in addition to 'Dream Big'.
Porsche Korea Officially Launches the New Cayenne, More Luxurious and More Powerful than Ever
Porsche Korea (CEO Holger Gerrmann) officially launched the new Cayenne (facelift of the 3rd generation) in Korea on the 17th. Three trims, the Cayenne, Cayenne Coupé, and Cayenne Turbo GT will be available, with customer delivery starting in September. The new Cayenne is positioned as the sportiest model in the SUV segment with its powerful engine and brand-new design, highly digitized display and control concepts, new chassis technology and innovative high-tech features. Porsche Korea CEO Holger Gerrmann stated, "The Porsche Cayenne is a style icon of the luxury SUV segment as well as a symbol of Porsche's continuous innovation.” He also added, "We look forward to the positive reactions of our fans and customers for the new Cayenne, which, despite being a facelift model, has undergone a complete makeover with the highest investment ever." Powered by a three-litre V6 turbo engine, the new Cayenne entry model has a maximum output of 360 PS and a torque of 51 kg·m. The Cayenne accelerates from 0 to 100km/h in 6 seconds and the Cayenne Coupé in 5.7 seconds, with a top speed of 248km/h for both models. The Cayenne Turbo GT, the flagship model of the portfolio, has maximized its on-road performance even further. Available in the dynamic Coupé design, it includes all the innovative and optimized features of the Cayenne. Powered by a four-litre V8 biturbo engine, its output marks 673 PS, and can accelerate from 0 to 100 km/h in breath-taking 3.3 seconds with 305 km/h top speed. Porsche has integrated a completely revised display and control concept into the new Cayenne. The Porsche Driver Experience, which was first introduced in the Porsche Taycan, offers a perfect balance between digital and analogue elements for optimized, driver focused operation. Frequently used functions have been placed around the steering wheel, and additional functions for operating the driver assistance systems are added to the left lever behind the steering wheel. The automatic transmission selector lever is located on the dashboard, providing an elegant black panel design for the air conditioning controller and a larger centre console space for storage compartments. Especially, in the new Cayenne, both the driver and the passenger can experience a fully redesigned cockpit. New interactive elements are combined to provide a brand-new driving experience. For the first time, the redesigned cockpit of the Cayenne includes a fully digital 12.6-inch instrument cluster with a so-called curved and free-standing design and variable display options. An optimised head-up display is available as an option. The standard 12.3-inch central Porsche Communication Management (PCM) display integrates harmoniously into the new dashboard and provides access to all the relevant vehicle functions. Native apps such as Spotify® and Apple Music® are provided to optimise connectivity in the new Cayenne. A 10.9-inch display is now available as an option for the first time for the passenger side. This enriches the front passenger’s driving experience by displaying performance data, providing separate access to the infotainment system controls and, depending on the market, the option of streaming video content on the road. A special foil ensures that the driver cannot see this display. The new Cayenne has a particularly expressive appearance. A new front end combined with more strongly arched wings, a new bonnet and technically appealing headlights emphasises the vehicle’s width. Three-dimensionally designed taillights, uncluttered surfaces beneath and a new rear apron with integrated number plate holder characterise the rear end design of the new Cayenne. An expanded colour palette with three new colours, lightweight sports packages saving up to 33 kilograms for the Cayenne Coupé, and a new extensive range of 20, 21, and 22-inch wheels make it possible to individually and dynamically configure the new Cayenne. The new Cayenne is equipped with a steel spring suspension including Porsche Active Suspension Management (PASM). New shock absorbers with 2-valve technology with separate rebound and compression stages allow optimised performance in all driving situations. In particular, comfort at low speeds, handling during dynamic cornering, and pitch and roll supports have also been significantly improved. The new adaptive air suspension with 2-chamber, 2-valve technology further enhances the driving experience. Compared to the predecessor models, the softer suspension characteristic stabilises the vehicle and simplifies on-road and off-road handling. The adaptive air suspension improves driving precision and performance and reduces body movement in dynamic driving situations. The suspension also offers an even sharper differentiation between Normal, Sport and Sport Plus driving modes. Matrix LED Headlights are now standard in the new Cayenne. Innovative HD Matrix LED Headlights are a new optional feature. With two high-definition modules and more than 32,000 pixels per headlamp, their technology picks out other users and blocks out the light of the high beam to them with pixel accuracy so as not to dazzle them. Porsche has also introduced an air quality system in the new Cayenne. As standard, the vehicle uses predictive navigation data to detect approaching tunnel entrances and automatically activates air recirculation. In addition, customers can use a comprehensive range of new and optimised assistance systems. These include the active speed limiter and the swerve assist, the cornering assist, and the improved Porsche InnoDrive as part of the adaptive cruise control. Porsche Korea is offering the new Cayenne, Cayenne Coupé, and Cayenne Turbo GT at 133.1 million, 137.8 million, and 261.9 million KRW respectively, including VAT. Since its introduction in 2002, the Porsche Cayenne became the brand’s best-selling model with over a million units sold. The cumulative sales record in Korea until July 2023 marks more than 25,000 units, establishing its worth in the Korean market. In addition, Porsche Korea is hosting a pop-up exhibition to celebrate the launch of the new Cayenne at L’espace Etnah Cheongdam in Gangnamgu, Seoul until August 27th. Under the theme "The Art of Living," the exhibition will feature various lifestyle experiences inspired by the refined luxury design and powerful performance of the new Cayenne. The new Cayenne models will be showcased in this special exhibition, adorned with a luxurious salon and garden to emphasize its villa concept. The exhibition is open to anyone via the Naver reservation system. In addition to the new Cayenne, a participatory program for visitors, including creating their own Cayenne whiskey glass and hashtag events are prepared. Porsche Rimowa carrier (1 person) will be provided through a lucky draw among hashtag event participants.
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Aflac Selects LTIMindtree As Digital Transformation Partner for Application Modernization and Cloud Transformation
The partnership will rearchitect Aflac’s legacy applications with a cloud-first approach in collaboration with AWS, ensuring performance efficiency, cost optimization, and operational excellence with heightened security.WARREN, N.J. & MUMBAI, India--(BUSINESS WIRE)--$LTIM #AWS--LTIMindtree [NSE: LTIM, BSE: 540005], a global technology consulting and digital solutions company, has been selected by Aflac Incorporated (NYSE: AFL), a Fortune 500 company and the largest provider of supplemental insurance in the United States, to digitally transform the organization by leveraging the cloud-native services of Amazon Web Services (AWS). As part of the engagement, LTIMindtree will rearchitect Aflac’s on-prem applications that are currently deployed on an out-of-support-platform. The cloud-first approach on AWS solution, built on reusable UI components and common business functionalities as services, will capitalize on the salient features of AWS tools such as Amazon CloudFront, AWS Key Management Service (KMS), AWS Secrets Manager, and Serverless components like Lambda to ensure that the solution design is in line with the AWS Well-Architected Framework, which is also secure and reliable. “In its current growth phase, Aflac is accelerating its digital transformation efforts, augmenting traditional in-person, independent agent/franchise business with a more digitally nuanced, seamless experience, which caters to the demand of stakeholders in real-time and securely,” said Polly Fabry, Director, Emerging Technologies, Aflac Incorporated. “Powered by LTIMindtree’s comprehensive end-to-end cloud migration expertise and factory-based delivery model and AWS’ flexibility, scalability and reliability, we are confident in moving above operational challenges, including competition to deliver greater visibility, performance efficiency, cost optimization and services without any disruption.” “Insurers today are seeking solutions that improve speed-to-market for new products while also managing escalating cost of operations, regulatory compliance, and security-related vulnerabilities,” said Sudhir Chaturvedi, President & Executive Board Member, LTIMindtree. “The comprehensive core modernization expertise, migration tools and accelerators, and core-to-experience proposition of LTIMindtree bundled with the cloud-native architecture of AWS components and services will help Aflac fully harness the digital and cloud ways of working, while allowing the user to efficiently traverse technology and operational diversities seamlessly and deliver positive business outcomes.” Moving to AWS will protect Aflac from security risk and positively impact its users, including the agent community. The applications are designed to follow the WCAG 2.1 guidelines, making it accessible to a wider audience. The Disaster Recovery capability has improved availability and uptime by more than 50%. Migration to AWS has reduced Total Cost of Ownership by over 20% and overall reduction in application hosting cost by over 30%. About Aflac Incorporated Aflac Incorporated (NYSE: AFL) is a Fortune 500 company helping provide protection to more than 50 million people through its subsidiaries in Japan and the U.S., paying cash fast when policyholders get sick or injured. For more than six decades, the insurance policies of Aflac Incorporated's subsidiaries have given policyholders the opportunity to focus on recovery, not financial stress. In the U.S., Aflac is the number one provider of supplemental health insurance products.1 Aflac Life Insurance Japan is the leading provider of medical and cancer insurance in Japan, where it insures 1 in 4 households. In 2021, the company became a signatory of the Principles for Responsible Investment (PRI). In 2022, the company was included in the Dow Jones Sustainability North America Index, as one of the World's Most Ethical Companies by Ethisphere for the 16th consecutive year, on Fortune's World's Most Admired Companies for the 22nd time and in Bloomberg's Gender-Equality Index for the fourth consecutive year. To find out how to get help with expenses health insurance doesn't cover, get to know us at aflac.com or aflac.com/espanol. Investors may learn more about Aflac Incorporated and its commitment to ESG and social responsibility at investors.aflac.com under "Sustainability". About LTIMindtree LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700 clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by 82,000+ talented and entrepreneurial professionals across more than 30 countries, LTIMindtree — a Larsen & Toubro Group company — combines the industry-acclaimed strengths of erstwhile Larsen and Toubro Infotech and Mindtree in solving the most complex business challenges and delivering transformation at scale. For more information, please visit https://www.ltimindtree.com/. 1LIMRA 2021 U.S. Supplemental Health Insurance Total Market Report Contacts Media ContactGitanjali.firstname.lastname@example.org
Research Results from Ontada HOPE Studies Presented at ASCO 2023 Illuminate How Social Determinants of Health Impact Different Patient Populations wit
Additional data presented investigates real-world outcomes for patients with metastatic non-small cell lung cancerBOSTON--(BUSINESS WIRE)--Ontada®, a McKesson business dedicated to leveraging oncology real-world evidence (RWE), clinical education, and provider technology to transform the fight against cancer, presented new data at the American Society of Clinical Oncology (ASCO) Annual Meeting which showed that 74 percent of patients with triple-negative breast cancer (TNBC) treated in a U.S community oncology network received genetic testing. However, significantly lower testing rates were observed for patients who were Black, had lower socioeconomic status, and resided in Southern or Midwestern geographic regions. In terms of treatment, researchers, in an additional study, did not observe inequities in the use of neoadjuvant chemotherapy (NC) based on social determinants of health (SDOH) analyzed, such as race, ethnicity, and Area Deprivation Index (ADI), a validated measure of socioeconomic status. Poorer outcomes observed in Black patients with TNBC may not be a result of underutilization of NC. This research is part of Ontada’s HOPE Studies (Health Outcomes Powered by Evidence), a program enabling providers to investigate unanswered questions through retrospective, non-interventional studies. “This new data provides insights on the crossroads of SDOH and TNBC, an aggressive form of one of the most common cancers, which disproportionately affects different patient populations with poor outcomes,” said study co-author Nicholas Robert, MD, chief medical officer, Ontada. “Studies addressing SDOH, such as these, have clinical real-world applicability to help identify potential factors that may impact care and outcomes for affected communities. To address barriers, further research should be performed to understand reasons why testing was not done.” Additional Ontada-affiliated studies were also presented at the Annual Meeting, one of which examined the availability and consistency of treatment response rate endpoints in patients with metastatic non-small cell lung cancer (mNSCLC) treated with chemotherapy across real-world datasets to understand how the utility of the data can be improved. Leveraging real-world data and evidence is significant and can accelerate development and access to needed treatments. In this study, seven organizations worked together to evaluate how real-world data (RWD) can be used to assess real-world response in patients with mNSCLC. While variability in the availability of data components to assess response was observed, the demonstrated feasibility of response endpoints based on clinical assessment suggests further exploration may inform drug effectiveness evaluation with RWD. “Real-world response is an important outcome in clinical oncology studies and is used to evaluate the effectiveness of treatments in the real world. However, there is no recognized standard for how this is assessed,” said study co-author Janet Espirito, PharmD, senior medical director, Ontada. “The primary goal of this study was to evaluate the availability and consistency of information across data sources. If several organizations used the same measures, would we get the same outcomes? We learned that there are consistencies, but now as industry leaders, we must continue to work together to develop best practices.” The full schedule of Ontada-affiliated studies being featured at ASCO, including authorship information, can be found here. About the Studies The impact of social determinants of health (SDOH) on use of germline genetic testing for triple-negative breast cancer (TNBC) in the community oncology setting (ASCO Poster) This was a retrospective observational cross-sectional study examining patient profiles, demographics, SDOH indicators, and germline genetic testing data. Patients in The US Oncology Network diagnosed with any stage TNBC between 3/31/2017 and 9/30/2021 aged 60 years or younger were identified. Data from the iKnowMed electronic health record (EHR) was used for patient identification, baseline characteristics, and social determinants, including area deprivation index (ADI), a validated measure of socioeconomic status (SES) based on address. Mean ADI percentile scores using national and state level benchmarks were calculated as well as stratifications above and below the 80th percentile (where higher scores > 80 are markers of low SES). Evidence of germline genetic testing (yes/no) was compiled from iKM, network genetic databases, and confirmatory chart audits. Only The US Oncology Network sites participating in confirmatory audits were included in this analysis. Social determinants of health and utilization of neoadjuvant chemotherapy in patients with triple negative breast cancer (TNBC) in the community oncology setting (ASCO Poster) This retrospective observational cross-sectional study examined patient profiles, treatment patterns, and SDOH indicators among patients newly diagnosed with early-stage breast cancer in The US Oncology Network. Using iKnowMed EHR data, patients diagnosed with TNBC between 03/31/2017 and 09/30/2021 with stages II-IIIB disease or tumor size ≥2cm (T2 or higher) were included. The initial TNBC diagnosis date was used as the index date for each patient and records were assessed from 6 months pre- to 6 months post-diagnosis for NC initiation, baseline characteristics, and social determinants, including Area Deprivation Index (ADI), a validated measure of socioeconomic status. Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets (ASCO Poster) This study included seven EHR data partners who identified and analyzed a cohort of 1,380 patients (pts) with metastatic non-small cell lung cancer (mNSCLC) treated with first-line platinum doublet chemotherapy, following a common protocol and statistical analysis plan. The availability and frequency of data components to assess response including raw images, radiology imaging reports, and clinician response assessments from provider notes were assessed. Response endpoints measured included real-world response rate (rwRR), real-world-duration of response (rwDOR), and the association of real-world response with real-world-overall survival (rwOS), real-world-time to treatment discontinuation (rwTTD), and real-world-time to next treatment (rwTTNT). About Ontada® Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the core belief that precise insights – delivered exactly at the point of need – can save more patients’ lives. We connect the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by all top 15 global life sciences companies. Our work helps accelerate innovation and power the future of cancer care. For more information, visit ontada.com. About McKesson Oncology and Specialty Solutions It’s an unprecedented time for patients living with cancer as life sciences companies race to create new, cutting-edge therapies. With cancer care becoming more targeted, providers, life sciences companies, and payers face a multitude of challenges and complexity in the development of new treatments and making them accessible to patients in need. At McKesson, our unmatched portfolio of oncology businesses and partners provide research, insights, technologies, and services that are helping to address these hurdles and improve cancer and specialty care. McKesson is fueling discovery by helping patients participate in cutting-edge clinical trials closer to home through the joint venture between US Oncology Research and Sarah Cannon Research Institute The US Oncology Network and McKesson Provider Solutions are advancing specialty care and high-quality cancer care in the communities where patients live by supporting the practices of thousands of independent, community-based providers. Ontada®, a McKesson business dedicated to oncology, generates real-world data (RWD) and real-world evidence (RWE) and provides clinical education and provider technology to inform and improve cancer care. As one of the largest distributors of oncology and specialty medicines, we are ensuring medicines make their way to the those who are counting on them. And through CoverMyMeds, Biologics by McKesson, and GPO services, our work continues to help patients access, afford, and adhere to their medicines. Contacts Claire Crye, Public Relations, 281-825-9927, email@example.com
Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastat
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago and online. The Phase II trial was conducted through The US Oncology Network. The results of this trial were published by Joyce O’Shaughnessy et al. (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005). The poster (Abstract #1037, poster #258), entitled, “Association of C-MYC, MYC target gene, and unfolded protein response (UPR) expression with clinical benefit from the oral aurora kinase A (AURKA) inhibitor, alisertib (A), in combination with paclitaxel (P) compared with P alone in patients (Pts) with HER2-negative metastatic breast cancer (MBC),” was presented at the Breast Cancer – Metastatic Poster Session by Sara A. Byron, Ph.D., Integrated Cancer Genomics Division, Translational Genomics Research Institute (TGen), part of City of Hope, on June 4 at 8:00 a.m. CDT. A copy of the poster is available on the Puma Biotechnology website. Archival tissue samples from patients enrolled in the clinical study were analyzed at TGen. Of the 140 patients enrolled in the trial, 45 from the alisertib plus paclitaxel arm and 51 from the paclitaxel arm had sufficient tissue available for next generation sequencing, and 31 from the alisertib plus paclitaxel arm and 35 from the paclitaxel arm had enough for RNA sequencing/gene set enrichment analysis. The most frequently mutated genes were PIK3CA (45%) and TP53 (44%). No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1. Increased MYC RNA expression was observed in tumors from patients who did not derive clinical benefit from paclitaxel alone (defined as PFS less than 6 months) compared to those with benefit from paclitaxel alone (defined as PFS greater than or equal to 6 months). Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel. Elevated expression of genes involved in MYC activation and in unfolded protein response (a pro-survival mechanism) were enriched in alisertib plus paclitaxel responders compared to paclitaxel responders and were associated with poor response to paclitaxel alone. In 12 patients with exceptional response to alisertib plus paclitaxel (defined as PFS greater than or equal to 12 months), increased expression of genes involved in MYC activation and in epithelial to mesenchymal transition (a hallmark of cancer progression and metastasis) was observed in comparison to cancers from patients whose disease progressed within 6 months of initiating alisertib + paclitaxel (n=11) or those with exceptional response to paclitaxel alone (n=4). “There continues to be a need for new drugs for the treatment of metastatic ER-positive, HER2-negative breast cancer and triple negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. “The results of this study and the subsequent biomarker analysis demonstrate that the addition of alisertib to paclitaxel may help to identify which patients are likely to derive the most benefit from alisertib and helps to identify biomarker focused populations that can be studied in future clinical trials of alisertib.” Sara Byron, Ph.D., Research Associate Professor in the Integrated Cancer Genomics Division at TGen, added, “We are pleased to have collaborated with Dr. O’ Shaughnessy on evaluating the effect of alisertib in this breast cancer trial. The biomarkers that were associated with clinical benefit to alisertib appeared to be the ones associated with an aurora kinase A inhibitor like alisertib, and we are hopeful that this work will help identify future patient populations that may benefit from alisertib.” Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are very pleased with the results of this biomarker analysis. We are committed to and focused on the development of alisertib in biomarker defined populations who may derive the greatest benefit from treatment with alisertib. This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 firstname.lastname@example.org@pumabiotechnology.com David Schull, +1 212 845 4200 email@example.com
Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles
Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual MeetingPRINCETON, N.J.--(BUSINESS WIRE)--$BMY #ASCO--Bristol Myers Squibb (NYSE: BMY) today announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC). With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial’s primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.63 to 0.87). With extended follow-up, the clinically meaningful efficacy benefit of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across secondary endpoints and key subgroups of patients, with benefits more pronounced amongst high unmet need patients with tumor PD-L1 expression <1% and squamous histology: PD-L1 <1%: Among patients with tumor PD-L1 expression <1%, the OS rate was 23% for those treated with the dual immunotherapy-based combination vs. 13% for chemotherapy alone, representing a 34% reduction in the risk of death (HR 0.66; 95% CI: 0.50 to 0.86). Squamous histology: Among those with squamous histology, twice the number of patients treated with Opdivo plus Yervoy with chemotherapy were alive at four years compared to those who received chemotherapy alone (20% vs. 10%, respectively). In this group, the dual immunotherapy combination reduced the risk of death by 36% compared to chemotherapy alone (HR 0.64; 95% CI: 0.48 to 0.84). No new safety signals were observed with Opdivo plus Yervoy with two cycles of chemotherapy with extended follow-up in the CheckMate -9LA trial. These data will be featured in a late-breaking poster presentation (Abstract #LBA9023) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023, from 5:30 - 7:00 p.m. EDT. “The durable results seen with nivolumab plus ipilimumab with chemotherapy over four years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic non-small cell lung cancer, which remains an incredibly challenging disease to treat,” said David P. Carbone, M.D., Ph.D., CheckMate -9LA investigator and Director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. “The data in patients with tumor PD-L1 expression <1% and squamous histology are particularly encouraging, as they show that the combination therapy continues to reduce the risk of death by approximately one-third compared to chemotherapy alone four years following treatment in patient groups historically facing the worst outcomes.” “Cancer treatment is never a one-size-fits-all approach given that patients with thoracic cancers like non-small cell lung cancer have diverse sets of needs. We are committed to researching solutions that work for more patients and can potentially help improve outcomes and fill areas of high unmet need,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Our data in lung cancer at ASCO 2023 add to the growing body of evidence supporting the potential of our medicines to improve long-term outcomes for patients in both advanced settings and earlier stages of disease, as well as difficult-to-treat patient groups requiring personalized approaches to treatment. The CheckMate -9LA results, which demonstrate sustained efficacy benefits over four years with an Opdivo-based combination, further reinforce our promise to deliver durable options to more patients across varying stages and types of cancer.” Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials in five tumors to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. About CheckMate -9LA CheckMate -9LA is an open-label, global multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm (n=361) were treated with immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival (OS) in the intent-to-treat (ITT) population. Secondary hierarchical endpoints included progression-free survival (PFS) and overall response rate (ORR), and the study also evaluated efficacy measures according to biomarkers. About Lung Cancer Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. About Yervoy Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years of age or older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0. 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Nucleai and Mayo Clinic BioPharma Diagnostics Announce Strategic Collaboration to Transform Digital Pathology for Drug Development and Clinical Practi
CHICAGO--(BUSINESS WIRE)--#biomarker--Nucleai, a leading provider of artificial intelligence (AI) solutions for pathology and spatial biology, and Mayo Clinic BioPharma Diagnostics are pleased to announce a strategic collaboration to bring world-class digital pathology solutions, technologies, and services to support drug development and clinical practice. This collaboration combines Nucleai’s AI-powered spatial biology technology with Mayo’s longitudinally annotated, multi-modal data sets, world-class lab services, and clinical diagnostic footprint. "We are excited to work closely with Mayo to bring spatial biology to the hands of the biopharma industry, clinicians and researchers,” said Avi Veidman, CEO of Nucleai. "By combining Mayo Clinic's extensive multi-modal datasets, laboratories, and clinical expertise with Nucleai's advanced AI platform, we can bring scale and impact to the entire precision medicine landscape.” Through this collaboration, Nucleai and Mayo Clinic will focus on several distinct offerings to support drug development including biomarker discovery and validation, end-to-end spatial biology testing and algorithm deployment for clinical trials and diagnostic use. About Nucleai: Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. For more information, please visit www.nucleai.ai. Contacts Jonathan Daniels VP, Head of Business Development and Strategy Email: firstname.lastname@example.org