Lufthansa Celebrates 65 Years Connecting Thailand with Europe
Lufthansa proudly marks a significant milestone in its history: the 65th anniversary of its inaugural flight from Hamburg to Bangkok. This milestone highlights the airline’s long-standing commitment to the Thai market and Mekong region, connecting cultures, facilitating travel, and fostering business relationships between Germany and Thailand. On November 1, 1959, Lufthansa’s first flight to Thailand took off from Hamburg, Germany, opening a new chapter in international air travel. LH640, then known as the Super Constellation, took off for the Far East from Hamburg via Düsseldorf, Frankfurt, Rome, Cairo, Karachi and Calcutta to Thailand on a spectacular journey that has lasted nearly 2 days. Since then, the airline has continuously expanded its service offerings, ensuring a seamless travel experience for passengers. Today, Lufthansa operates multiple weekly flights between Europe and Thailand, providing exceptional service and convenience to travelers via its hubs in Munich, & Frankfurt. In addition to the mainline carrier, the airlines of the Lufthansa Group connect Thailand with Europe via additional hubs in Zurich and Vienna with up to 31 weekly flights between Thailand and Europe. According to Lufthansa Group Vice President Asia Pacific & Joint Ventures East, Felipe Bonifatti: “This anniversary is a testament to our dedication to serving our customers and connecting them with the world. Bangkok has been - and remains - a vital destination for us, and we look forward to continuing to enhance our services as we celebrate the rich Lufthansa history in Thailand. With a legacy that stretches more than six decades, we operate more flights to Thailand than any other European airline group and are delighted to have resumed A380 services to Bangkok just last month." Lufthansa’s commitment to innovation and sustainability remains at the forefront as the airline continues to evolve its services. From modernizing its fleet to implementing eco-friendly initiatives, Lufthansa is dedicated to providing a responsible and enjoyable travel experience for Thai passengers. As Lufthansa looks ahead, it remains focused on strengthening its connections and enriching the travel experience for passengers. Here’s to another 65 years of excellence in the skies.
Porsche Korea Opens ‘Overwatch 2’ Collaboration Pop-up Store
Porsche Korea (CEO Mathias Busse) announced the opening of a pop-up store at IFC Mall in Yeongdeungpo-gu, Seoul, to celebrate its collaboration with Blizzard Entertainment®'s team-based shooter game, ‘Overwatch 2®’, until November 10th. This pop-up store is part of the global partnership between Porsche AG and Blizzard Entertainment, aiming to convey Porsche's passion for the brand to both the young and diverse fanbase of "Overwatch 2" and the broader gaming community in an unexpected, entertaining way. Already established in racing games, the sports car manufacturer is also expanding its portfolio beyond the motorsport genre. Porsche Korea is continuing the unique brand experience by showcasing its first electric SUV, the Macan Electric, at this pop-up store, which replicates the futuristic cityscape of "Overwatch 2." Mathias Busse, CEO of Porsche Korea, stated “The collaboration between Porsche and Overwatch 2 offers an exclusive brand experience.” He added, " I hope many customers can meet the Macan Electric, which will be unveiled before its official launch in Korea, and experience Porsche's innovative E-Performance at Overwatch 2 pop-up store.” The pop-up store will also feature a life-sized mech statue of the popular character D.Va. Additionally, visitors can participate in an OX quiz themed around the Macan Electric at a kiosk, as well as slot machine game and random vending machine celebrating the collaboration between Porsche and Blizzard. By participating, they will have the chance to receive various prizes, including a suitcase, model car, wooden car and tumbler from the Porsche lifestyle goods. The Macan Electric was first unveiled in Korea in June, alongside the Macan 4 and Macan Turbo, receiving positive reviews from media and customers for Porsche's innovative E-Performance, new Porsche Driver Experience, and a progressive yet timeless impressive design. The starting prices for the Macan, Macan 4, Macan 4S, and Macan Turbo Electric are 99.1 million KRW, 105.9 million KRW, 114.4 million KRW, and 138.5 million KRW, respectively. Meanwhile, Porsche AG set up a booth inspired by Busan, the hometown of Overwatch character D.Va, at the world's largest gaming exhibition, Gamescom 2024 in August. They also showcased a Macan Electric featuring an Overwatch-themed livery.
General Motors Participates in 2024 Korea Future Mobility Expo and Presents Direction of Mobility
Daegu — GM Technical Center Korea, General Motors’ engineering center in Korea, is participating in the 2024 Daegu International Future Auto & Mobility Expo (DIFA) 2024 at Daegu EXCO from October 23-26. It is enabling the automaker to showcase its core technologies and latest models, and introduce its vision for the direction of future mobility. “As a company that is leading the future of the automobile industry, GM is pleased to be participating in Korea’s representative mobility expo,” said GM Technical Center Korea President Brian McMurray. “We are highlighting GM’s innovative technologies and providing an opportunity for visitors to see where the industry is headed in the future.” He added, “We are especially excited to be welcoming many talented young individuals who will lead future mobility. GM is committed to making the world a better place for all and we are doing that with great technology and a great innovative team right here in Korea.” GM has taken part in DIFA for three consecutive years. It is engaged in DIFA 2024 through its Korean research and development organization, which is helping to lead GM’s future growth strategy. The Product Showcase Zone is exhibiting GM’s latest products and technologies, while the Heritage Zone and Cruise Zone is introducing GM’s 120-year history and future mobility technologies, and the Career Consulting Zone has been tailored for student visitors. Various GM models are on display in the Product Showcase Zone, allowing visitors to directly experience GM’s cutting-edge technology and design capabilities, from internal combustion engine vehicles to electric vehicles. The eighth-generation Corvette, the supercar representing the Chevrolet brand, is being exhibited for the first time in Korea, alongside various other high-performance models, such as Cadillac’s first pure electric SUV, the LYRIQ, to delight visitors. The Heritage Zone and Cruise Zone was created to highlight GM’s century-plus history of innovation, which has made it a global automobile industry leader. GM’s next-generation technologies that will lead the future of mobility, such as Cruise Automation, a GM subsidiary that provides autonomous taxi services, and Super Cruise, its hands-free driving technology, are also being featured. The Career Consulting Zone is a space where GM executives and employees can directly mentor students visiting the booth with their engineering knowledge and experience to provide in-depth information on products and technologies and support the dreams of future talent. DIFA, now in its eighth year, is a mobility event co-hosted by the Ministry of Land, Infrastructure and Transport, the Ministry of Trade, Industry and Energy, and Daegu Metropolitan City as the 2024 Future Innovation Technology Expo (FIX 2024). Approximately 190 domestic and international companies and organizations are participating, making it the largest exhibition of its kind in Korea covering the entire mobility spectrum, including eco-friendly and future mobility, as well as parts and infrastructure. GM Technical Center Korea is the second-largest GM engineering center in the world after the United States and has facilities capable of complete vehicle development, from design to engineering, final vehicle verification, and production technology. It is also playing a key role in the global engineering field for the advancement of GM’s electrification and future mobility technologies.
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Tracing the Cultural Links Between Korea and Pakistan, Through Gandhara Cultural Heritage
Korea Heritage Service (Administrator Choi Eung-Chon) and the Korea Heritage Agency (President Choi Young-Chang) have begun a joint excavation of the Mankiala Stupa in collaboration with the Department of Archaeology and Museums, Islamabad (Director-General Dr. Abdul Azeem). *Stupa: A rounded tomb and an anti-sphere structure that contained the relics of Buddha **Mankiala Stupa: A Buddhist stupa located in the northwestern part of Pakistan, approximately 20 km southeast of Islamabad, the capital city. It is believed to have originated around 1-2 AD and remains in good condition, particularly in the upper part, allowing for an assumption of its original shape. In this project, two experts from the Korea Heritage Agency (an archaeology specialist and a conservation scientist) and seven students from the Department of Archaeology at Quaid-I-Azam University, who are expected to lead the future of archaeology in Pakistan, are also participating. The project mainly focuses on capacity building, including training on the use of equipment that are recently being used in excavation sites. The project will take place from October 7th to December 6th. Professor Ghani-ur-Rahman, the Director of Taxlia Institue of Asian Civilizations at Quaid-I-Azam University stated, “This project will be an excellent opportunity for students, as there was no archaeological excavation project in Islamabad since 2016,” He also added that he selected the most brilliant senior level students to participate in the excavation. The Joint Excavation Project of the Gandhara Ruins at ‘Mankiala’ is being conducted as part of a Korean ODA (Official Development Assistance) project in Pakistan. The goal of this project is to enhance capacity for preserving cultural heritage by teaching the use of the latest technologies, such as Drone, GNSS (Global Navigation Satellite System) and Total station. Especially, as a pilot project under provisions of the agreement between Pakistan and Korea.Project mainly focuses on capacity building and uncovering the lower buried structures of the Mankiala Stupa. The data collected during excavation will be useful for preservation and conservation of the stupa. Mr. Hassan Nasir Jamy, The Secretary of the National Heritage and Culture Division stated, “We appreciate the efforts of the Korean Government in cooperating in the field of cultural heritage and hope this project not only builds capacity of our cultural heritage professionals for preserving cultural heritage but also nurtures future generations of archaeologists in Pakistan.” Mankiala Stupa is very popular in Korea as the Stone Pagoda of Casket Seal Dharani (Bohyeobin Stupa), designated as a National Treasure and currently housed at Dongguk University Museum, is beautifully adorned with carvings of the "Prince Sattva Jataka" story which is associated with the Mankiala Stupa. The Mankiala Stupa in the Rawalpindi region is known as the site where Prince Sattva (Salta) offered his body to a starving tigress. Due to its massive size, the stupa is easily visible from afar and is recognized as one of the four great stupas in the region, which flourished during the Gandhara period. This is the site where the current joint excavation is taking place. Pakistan has accumulated a rich cultural heritage from ancient times, including the Indus Civilization, Gandhara art, and Islamic architectural heritage. The Korea Heritage Agency will continue to provide support and cooperation in the fields of culture and tourism through the ODA project. ### 1 The Tale of Prince Sattva (Jataka): Before attaining nirvana in his final life, the Buddha (Siddhartha Gautama) accumulated virtue through countless previous lives. One such story is the Tale of Prince Sattva, who sacrificed his own flesh and blood to save a starving tigress. This story was introduced to Korea at an early stage and is even mentioned in the conversation between King Beopheung and Ichadon in the Samguk Yusa.
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Genesis BBQ Steals the Spotlight at Seoul’s Biggest Global Influencer Halloween Bash in Gangnam
Genesis BBQ Group, world’s largest K-food franchise powerhouse renowned for its ownership of the No. 1 K-chicken brand “BBQ,” took Halloween to dazzling new heights on October 28th. Collaborating with @seoul.southkorea, a travel account boasting 1.5 million followers, Genesis BBQ Group was the center of attention at the largest-ever global influencer Halloween bash in Gangnam. More than 200 high-profile influencers from around the world joined the exclusive event, and the BBQ booth quickly became the night’s main attraction. ■ BBQ Booth: The Night’s Ultimate Hotspot The vibrant booth set up by Genesis BBQ Group was a magnet for influencers from diverse industries—fashion, music, acting, and entrepreneurship—all eager to sample BBQ’s signature Golden Olive Chicken, alongside the brand's other best sellers. With a minimum follower count of 20,000 required for entry, the event attracted a highly curated guest list, featuring some of social media’s most prominent stars who couldn’t get enough of BBQ Chicken’s mouthwatering flavors and dynamic booth atmosphere. The BBQ booth’s red-carpet press wall, interactive social media contests, and the viral “APT” dance challenge quickly made it the night’s most talked-about destination. Under the visionary leadership of Tamara T. H. Kim, who made headlines earlier this year as the youngest executive in Korea’s F&B industry, Genesis BBQ Group’s latest rebranding efforts were on full display. Kim has redefined BBQ as a global cultural icon cherished by a new generation worldwide. “The BBQ booth didn’t merely attract attention; it captured hearts,” Kim shared. “This was more than a celebration—it was a moment of connection, uniting people from all walks of life through the uniquely Korean flavors of the nation’s favorite chicken brand. True quality knows no borders.” ■ Exclusive Performances and Unforgettable Moments Enhancing the evening’s excitement were live dance performances, a DJ, and a special set from popular R&B artist Jword, who gave the crowd an exclusive sneak peek of his upcoming album Atlanta Seoul. “BBQ’s Black Pepper Chicken is hands down the best fried chicken of all time,” exclaimed Jword, cradling his special box of BBQ Chicken. “It just hits different. Trust me, I’m from Atlanta!” Jword’s performance electrified the atmosphere, perfectly aligning with BBQ’s mission of blending culinary and cultural experiences. The BBQ booth, complete with a Hollywood-inspired press wall equipped with a proper red carpet, wasn’t just about food; it offered a truly immersive experience. Guests snapped photos, filmed videos, and joined the trending “APT” dance challenge inspired by Rosé’s latest single. The night’s energy peaked with a social media contest with prizes totaling 800,000KRW in value—including an invitation to the coveted BBQ Village Chimakase, a premium dining experience that highlights Genesis BBQ Group’s dedication to culinary excellence. ■ Innovative Engagements and Memorable Content When asked what set BBQ apart as the evening’s star, Chris Georgiev and Jinmin Park, managers of @seoul.southkorea, summed it up as they sipped BBQ’s famous Lemon Pu’er Tea Highball: “Genesis BBQ Group truly lived up to its name—Best of the Best Quality. We are incredibly proud to see our favorite K-chicken brand shine.” The event underscored Genesis BBQ Group’s mission to connect with the next generation and bring the BBQ experience to a global audience. Since 1995, BBQ Chicken has been a household name in Korea, cherished for its commitment to premium ingredients like high-quality frying oil and locally-sourced chicken. Now with a presence in over 60 countries, BBQ Chicken has become a global icon of the K-food phenomenon, featured in hit K-Dramas like The King: Eternal Monarch, Goblin, and Crash Landing on You, and adored by international superstars like BTS. With fans spanning all generations, BBQ has become more than just a brand—it is a treasured part of Korean heritage. Attendees shared their best moments on social media, tagging @GenesisBBQgroup and #BestoftheBestQuality. For more updates on Genesis BBQ Group’s upcoming events and social media giveaways, follow @GenesisBBQGroup on Instagram.
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The Korea Heritage Agency will present a Korean national heritage media art in Gangneung, and Las Vegas
The Korea Heritage Service (Administrator Choi Eung-cheon) and the Korea Heritage Agency (President Choi Young-chang) are set to present a Korean national heritage media art exhibition titled <The Heritage Garden – Threads of Connection> at the Arte Museum in Gangneung Gangwon Province, Korea, and Las Vegas, Nevada, U.S.A. The exhibition will open with a ceremony at Arte Museum Gangneung on the 12th and will be held at Arte Museum Las Vegas starting on the 19th. Both exhibitions will run until December 20. ‘Arte Museum’, an immersive media art exhibition space with over 8 million visitors across eight locations worldwide, including Gangneung, Busan, Yeosu, and Jeju in Korea, as well as Las Vegas, Hong Kong, and Dubai internationally, will for the first time, in collaboration with the Korea Heritage Agency, present a media art exhibition based on Korean national heritage. The exhibition <The Heritage Garden> will feature the media art Threads of Connection, which captures the beauty of Korea’s cultural heritage, intangible cultural heritage, and royal palaces. This production was created in collaboration with d’strict, a leading media art company. ‘Threads of Connection’ utilizes ‘national heritage 3D Assets*’ to convey the timeless beauty of Korean national heritage through a blend of past and present. The piece expresses the value of national heritage with lines of light, offering audiences a new dimension of experience through the fusion of cultural heritage and media art. Additionally, the background music, which reinterprets traditional Korean music such as Sujecheon (Korean court music) and Binari (a shaman’s song) with a modern sensibility, enhances viewers’ immersion in the exhibition. * national heritage 3D Assets: digitally visualized data of Korean national heritage The exhibition <The Heritage Garden> will feature ‘Threads of Connection’ alongside ‘ARTE MUSEUM × Musée d’Orsay’, which displays the works of famous Western painters. In addition, ARTE MUSEUM Las Vegas will present the Light of Las Vegas, which displays a panoramic view of Las Vegas colored with myriad lights. Meanwhile, both ARTE MUSEUM Gangneung and ARTE MUSEUM Las Vegas will organize various events, including free admission during the exhibition period. ▲ Visitors can enter the exhibition at ARTE MUSEUM Gangneung free of charge upon presentation of the stamps they receive after visiting more than two destinations of the National Heritage Visit Course in Gangneung (including Seongyojang House, Ojukheon House, and Gyeongpodae Pavilion). ▲ ARTE MUSEUM Las Vegas will offer special invitation cards to Korean community associations and Korean Cultural Centers in the U.S.A. so that Korean residents can enjoy the exhibition. In addition, an event is planned in which the first 200 passengers who purchase a Korean Air flight ticket from Incheon to Las Vegas and stay in the U.S.A during the exhibition period (Nov. 11 to Dec. 20, 2024) will be given a special invitation card (one per person). This event information will be found on the Korean Air website.
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[CES 2021] LG Emphasized "Needs to Innovate Beyond Boundaries Between Fields in the New Normal Era" Through Future Talk
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[CES 2021] Sony Unveiled Its Latest Initiatives Surpassing “Limits of Creativity” at CES 2021
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Hyperconnect, Key to social platform success: reflecting the ‘user voice’
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Hyperconnect : real-time video AI monitoring system can now auto-block live video content within 0.006 seconds
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India Credit Card Market Competition, Forecasts & Opportunities, 2028F - A Shift from Debit-based to Credit-based Economy and Emergence of Co-branded
DUBLIN--(BUSINESS WIRE)--The "India Credit Card Market Competition Forecast & Opportunities, 2028" report has been added to ResearchAndMarkets.com's offering. The Indian credit card market is poised to exhibit robust growth to 2028 The increasing adoption of cashless transactions, coupled with enticing credit card offers, rising acceptance of credit cards, a shift from debit-based to credit-based economy, and the emergence of co-branded card offerings are driving this growth. India's credit card market has undergone significant expansion, characterized by rapid technological advancements. Noteworthy developments, including streamlined onboarding processes, unique card products, personalized offers and rewards, and enhanced mobile apps, have proven advantageous to existing customers while attracting new ones. Credit card issuers are diligently working to raise awareness and foster innovation in this market, and the notable growth of the credit card market in India attests to these efforts. As of July 2022, there were 78 million active credit cards in circulation. Moreover, credit card spending reached a record high of USD 15.16 billion (INR 1.13 lakh crore) in May 2022. The growth trajectory, however, experienced a minor dip during FY 2020-21 due to the COVID-19 pandemic, resulting in a modest 9% increase in credit card spending. This occurred despite the overall uptick in credit card usage. Notably, the Reserve Bank of India (RBI) intervened to curb some of the major credit card issuers from issuing new cards in India during this period. Following the wave of demonetization and government initiatives to promote a cashless economy, credit card acceptance has witnessed a surge in India. Point-of-sale (POS) terminals across the country have adapted to accepting credit cards for a diverse range of goods and services. For instance, as of November 2022, India boasts 131,998,684 POS terminals, affirming the widespread adoption of credit cards. The rise of digital payments, particularly Unified Payments Interface (UPI) transactions, has significantly impacted the credit card industry. Factors such as smartphone proliferation, affordable internet access, and widespread merchant acceptance have propelled UPI transactions. Fintech companies are collaborating with traditional banks to offer credit cards and various digital lending services, including buy now, pay later (BNPL) and equated monthly installment (EMI) options. For example, RuPay credit cards, primarily issued by public sector banks, can now be linked to UPI apps, enabling QR-based credit payments at physical stores and streamlining payment processes for consumers. Market Growth Hindered by Limited Credit Card Penetration Comparatively, the United States boasts 1.5 billion active credit cards, constituting 67% of all active cards in the country. The widespread use of credit cards for purchases is prominent in the US due to convenience and straightforward usage, minimizing concerns about account-related fraud. In India, psychological factors continue to impact penetration. The conservative middle class exhibits reservations about using credit cards and credit in general. Perceived high interest rates and uncertainty about credit card benefits are obstacles to credit card market expansion. Nonetheless, credit card companies have countered these challenges by offering extra perks such as discounts, travel points, and other incentives to attract customers. Diverse Offers with Credit Cards Credit card usage offers users a myriad of advantages when making online payments for various services. These benefits include rewards, vouchers, cashback offers, and more, enhancing the value proposition of credit card payments for activities such as hotel bookings, mobile recharges, movie tickets, and shopping. Notable credit cards like HDFC Bank Regalia Credit Card and SBI Card Elite offer cardholders lounge access, golf privileges, dining and retail discounts, reward points, and travel insurance, amplifying the attractiveness of credit card usage. Entry of NBFCs Fueling Market Competition The credit card market is highly concentrated, with the top six issuers accounting for 81% of the market. However, with an estimated 350 million people anticipated to access online shopping in the next five years, more players are needed. The RBI's more permissive approach toward allowing Non-Banking Financial Companies (NBFCs) to launch credit businesses, provided they meet specific net worth criteria, will foster competition and encourage new entrants into the credit card market. Competitive Landscape Company Profiles: Detailed analysis of the major companies present in India Credit Card market. HDFC Bank Limited SBI Cards and Payment Services Limited ICICI Bank Limited Axis Bank Limited Citibank India Bank of Baroda RBL Bank Ltd. Kotak Mahindra Bank Limited Punjab National Bank IndusInd Bank Market Dynamics Drivers Increasing Adoption of Cashless Transactions Attractive Offers on Usage of Credit Cards Rising Acceptance of Credit Cards Market Trends & Developments Increasing Penetration of Co-Branded Cards Increasing Security Adoption of 5G Digital India Initiative Rising Contactless Payments Challenges Credit Card Payment Defaults High Interest and Charges Voice of Customer Analysis (B2C Model Analysis) Sample Size Determination Respondent Demographics By Gender By Age By Occupation Most Important Factors Determining Usage for Credit Card Users Factors Influencing Credit Card Adoption in India Leading Credit Card Companies in Terms of Customer Service Frequency of Review of Credit Score by Credit Card Users Purpose of Using Credit Card Readiness to Increase Credit Limit Report Scope India Credit Card Market, by Type: General Purpose Private Label India Credit Card Market, Service Providing Company: Visa Mastercard RuPay Others India Credit Card Market, Credit Limit: Up to 25 K 25-50K 51k-2L 2-5L India Credit Card Market, Card Type: Base Signature Platinum India Credit Card Market, Benefits: Cashback Voucher India Credit Card Market, by Region: North West South East For more information about this report visit https://www.researchandmarkets.com/r/cjsdmb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Contacts ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
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The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center. The HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D) Study, is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing. “I have been advising ReGelTec on their injectable hydrogel for chronic low back pain for more than four years and was able to treat a number of patients with the device during the initial studies performed outside the United States. The early results are excellenti and I can’t wait to begin the HYDRAFIL-D Study here in Oklahoma City,” said Dr. Douglas Beall, Chief of Interventional Spine Services, Comprehensive Specialty Care, Edmond, Oklahoma, who is an advisor to ReGelTec and one of two national principal investigators for the trial. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. in Walnut Creek, CA and the other national principal investigator said, “the HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery. When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients, and we are excited to demonstrate the value of the technology in this randomized, controlled trial.” “Obtaining IDE Approval for the HYDRAFIL-D Study from the FDA is a major milestone for ReGelTec,” said Bill Niland, the company’s co-founder and CEO who has successfully founded and exited multiple healthcare companies including Harpoon Medical, Inc., Vapotherm (NYSE:VAPO), and National Sleep Technologies. The company has treated more than 70 patients with 1-year follow-up on the first sixty patients showing a 69% reduction in pain scores and an 81% improvement in Oswestry Disability Index, a measurement of how low back pain is impacting a person’s daily living.ii Mr. Niland said that “once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval, and now we are fundraising to secure the capital needed to fund the study and attain FDA approval.” ABOUT REGELTEC, INC: ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL®, a percutaneous treatment for chronic low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful exits. The HYDRAFIL System contains a hydrogel that can be injected into a degenerated disc via a needle. Once approved, HYDRAFIL will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. The HYDRAFIL System is an investigational device, limited by United States law to investigational use. i https://www.jvir.org/article/S1051-0443(23)00694-2/pdfii Internal data on file Contacts Peter Boyd (443) 451-3915 pboyd@regeltec.com
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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 info@pumabiotechnology.comir@pumabiotechnology.com David Schull, +1 212 845 4200 david.schull@russopartnersllc.com
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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. Contacts Bristol Myers Squibb Media Inquiries:media@bms.com Investors:investor.relations@bms.com Read full story here
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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: jonathan@nucleai.ai