Enjoy Unlimited Access to Seoul's Five Palaces with ‘K-Royal Palaces PASS’
The Cultural Heritage Administration and the Korea Cultural Heritage Foundation announced that they will begin selling the ‘K-Royal Palaces PASS’ from April 18. The pass can be purchased at Ticketlink and global platforms including Klook, from March 18 to April 26. The K-Royal Culture Festival is the largest cultural heritage festival in Korea held every spring and autumn at five palaces in Seoul(Gyeongbokgung Palace, Changdeokgung Palace, Deoksugung Palace, Changgyeonggung Palace, and Gyeonghuigung Palace) and Jongmyo Shrine, celebrating its 10th anniversary this year. The 10th K-Royal Culture Festival will be held twice a year, in spring and autumn, and the spring festival is scheduled to take place from April 27 to May 5. The ‘K-Royal Palaces PASS’ is a special admission pass offering unlimited access to Seoul's five royal palaces during the spring festival period, priced at KRW 10,000. Pre-purchased tickets can be collected at Incheon International Airport or at festival information booths installed at each palace. This year, the K-Royal Palaces Pass comes with various benefits. It includes T-Money transportation card functionality, with 3,000 won recharge to commemorate the 10th anniversary, allowing continued use as a transportation card after the festival period. Additionally, various partnership discounts will be offered, including ▲a 10% discount on cultural products and beverages of café and art shop ‘Sarang’ at the palaces and Incheon International Airport, ▲a 10% discount on Korean traditional meals at Korea House, and ▲a 30% discount on the musical "The Tribe" at the Sejong Center. Only 1,000 passes were sold as a trial to domestic visitors last year, but the number has been dramatically increased to 10,000 this year to provide more opportunities for visitors, with sales taking place on both domestic and global platforms. Starting from March 18, the pass can be purchased at global platforms including Klook, Trippose, TRAVELNOTE. By the following week, the purchase will also be available through KKday, and JollyBuy and from April through Imoto Wi-Fi and HanYouWang as well. In Korea, online pre-sales will be conducted through Ticketlink starting from April 5. For early bird tickets purchased through Ticketlink limited to 200 people, the benefit of complimentary admission to the opening ceremony of the K-Royal Culture Festival on April 26 will be offered. On-site sales will be open if there are unsold tickets online. For more information about the the ‘K-Royal Palaces PASS’, check out the website of the Korea Cultural Heritage Foundation (www.chf.or.kr) and the website of K-Royal Culture Festival( www.chf.or.kr/fest ).
The 29th Busan International Film Festival Opens Submissions
The 29th Busan International Film Festival (BIFF), which will be held for 10 days from Oct 2 (Wed) to Oct 11 (Fri), is now accepting submissions for this year’s official selections. - Opening Submissions for the Highly Anticipated BIFF 2024 Official Selections Online Submission Deadline Short Films: June 19 (Wed), 18:00 (KST) Feature Films: July 17 (Wed), 18:00 (KST) The 29th Busan International Film Festival is earnestly starting preparations for this year’s event as it opens submissions for the official selections. To meet the eligibility requirement, the submissions must be fiction films, documentaries, and animations that were produced after October of 2023 and to be completed before September 2024. The submission will be categorized into two sections: Short Film for films shorter than 60 minutes and Feature Film for films longer than 60 minutes. Wide Angle - Korean Short Film Competition and Wide Angle - Asian Short Film Competition will only accept films of running time shorter than 30 minutes. Furthermore, short documentaries from Asia and non-Asian regions, short fiction films from non-Asian regions, and past BIFF submissions are not eligible for submission. Submissions for this year’s official selections are only available through the festival’s official website (www.biff.kr/eng/). The submission deadline for short films is June 19 (Wed), 18:00 (KST), and for feature films, July 17 (Wed), 18:00 (KST). The official website's Submission Guide (https://www.biff.kr/eng/addon/10000001/page.asp?page_num=7959) provides more information on eligibility, the submission process, the deadline, etc. Last year, BIFF was able to host a more successful event than ever before with more than 140,000 participants by focusing on the festival's core values to gather together and enjoy films. The festival was met with an enthusiastic response from the audience, with the attendance of world-renowned domestic and international film professionals, a Special Program in Focus that brought together Korean-American directors and actors active in Hollywood, and various events and attractions. Busan International Film Festival, which is setting out for a new beginning with a newly instated executive committee, continues to be dedicated to introducing promising directors and projects in Asia and fulfilling its role of connecting the audience and films. This year’s official selections will be available for screening at the 29th Busan International Film Festival, which will be held for 10 days from Oct 2 (Wed) to Oct 11 (Fri) in the vicinity of Busan Cinema Center. ■ The 29th Busan International Film Festival: Oct 2 (Wed) – Oct 11 (Fri) ■ The 19th Asian Contents & Film Market: Oct 5 (Sat) – Oct 8 (Tues)
Lufthansa Group generates operating profit of 2.7 billion euros in 2023 and invests more than ever for its customers
Carsten Spohr, Chairman of the Executive Board and CEO of Deutsche Lufthansa AG, says: "The Lufthansa Group has regained its financial strength. I would like to thank our customers for their continued loyalty and each and every one of our approximately 100,000 employees. With their above-average commitment, they made 2023 one of the three best years in Lufthansa Group's history. This success benefits everyone. We want to pay our shareholders a dividend for the first time since 2019. We are also giving our employees a share in our good results development through significantly above-average collective wage agreements and profit-sharings. And this year, we also aim to finally return our customers' satisfaction to premium levels. That is why we are investing the record amount of 4.5 billion euros in new aircraft, in our cabin interiors, lounges, ground processes and in personal and digital services. As part of the largest fleet modernization in our history, we expect to take delivery of at least 30 new aircraft this year, including around 20 long-haul jets for Lufthansa - another record!” Result 2023 In the financial year 2023, the Lufthansa Group generated the third-best financial result in its history due to the continued high demand for air travel and another record result at Lufthansa Technik. Revenue increased to 35.4 billion euros (previous year: 30.9 billion euros). Operating profit, measured as Adjusted EBIT, rose to 2.7 billion euros (previous year: 1.5 billion euros). The Adjusted EBIT margin improved accordingly to 7.6 percent (previous year: 4.9 percent). The company more than doubled its net profit to 1.7 billion euros (previous year: 790 million euros). The return on capital employed (Adjusted ROCE) rose by 5.5 percentage points to 13.1 percent (previous year: 7.6 percent). Adjusted ROCE thereby exceeded the 2024 target value of ten percent already one year ahead of time. Passenger numbers and traffic development The desire to travel remained high last year. Demand for tickets rose once again. In 2023, a total of 123 million passengers travelled with the airlines of the Lufthansa Group, an increase of 20 percent compared to the previous year (2022: 102 million). The Lufthansa Group airlines increased the number of flights offered by 14 percent to 946,000. The number of seats on offer was gradually expanded over the course of the year. On average, the airlines offered 84 percent of 2019 capacity last year. The seat load factor improved by 3.1 percentage points to around 83 percent, returning to pre-crisis levels. The company’s top priority in capacity planning was to ensure stable flight operations and the associated improvement in the customer experience. 98 percent of all flights were able to take place as planned. As a result of the required buffers in the system, however, productivity was significantly below the pre-crisis level of 2019, particularly at the core Lufthansa brand. Passenger airlines with profit The high demand and increased capacity led to significant revenue growth at the passenger airlines. Revenue rose to 28.3 billion euros in the 2023 financial year (previous year: 22.8 billion euros). Yields continued to develop positively and were around six percent higher than in the previous year. The increase was mainly driven by the continued strong demand in the leisure travel segment, particularly in the premium classes and during the record travel summer. Business travel continued to recover at a slower pace. Despite high cost inflation, Adjusted EBIT of the passenger airlines segment improved significantly in the past financial year. At 2.0 billion euros (previous year: -300 million euros), it was once again clearly positive. For the first time, all passenger airlines in the Group reported an operating profit. SWISS, Austrian Airlines, Brussels Airlines and Eurowings all achieved record results. Lufthansa Technik with record result, logistics result normalizes Demand for maintenance, overhaul and repair services and other Lufthansa Technik products remained high in the financial year 2023. Despite strained supply chains and rising material and personnel costs, Lufthansa Technik once again generated a record result in 2023. The operating profit for the past financial year amounted to 628 million euros (previous year: 554 million euros). With its “Ambition 2030” growth plan, Lufthansa Technik is planning extensive investments in the expansion of its core business, the expansion of its global locations and the expansion of digital business models for the coming years. Following some exceptional record years, demand for air freight has mostly normalized in 2023. Lufthansa Cargo's capacity increased by seven percent compared to the previous year, primarily due to the further recovery in passenger air traffic and the associated expansion of cargo capacity on passenger aircraft. Lufthansa Cargo generated Adjusted EBIT of 219 euros million in the financial year (previous year: 1.6 billion euros), which corresponds to a persistently strong operating margin of 7.4 percent. Strong Adjusted Free Cashflow further reduces net debt To ensure the company's long-term ability to invest and further reduce debt, the focus in the 2023 financial year was once again on the generation of a strong cash flow. Due to the good operating result, increasing bookings and strict management of receivables and liabilities, operating cashflow amounted to 4.9 billion euros (previous year: 5.2 billion euros). The previous year's figure included one-off effects resulting from the sharp ramp-up in demand after the end of the coronavirus restrictions. The Lufthansa Group's net capital expenditure rose by 23 percent year-on-year to 2.8 billion euros in 2023. The largest share of this was attributable to the modernization of the fleet through the purchase of new, fuel-efficient aircraft. Overall, the company generated an Adjusted Free Cashflow of 1.8 billion euros (previous year: 2.5 billion euros). This is the third highest free cashflow in the history of the Lufthansa Group. Due to the positive free cashflow, net debt fell significantly to 5.7 billion euros (previous year: 6.9 billion euros) and was thereby around 1 billion euros below the pre-crisis level. Net pension obligations increased by 683 million euros to 2.7 billion euros (December 31, 2022: 2.0 billion euros) due to a 60 basis point decrease in the discount rate. Equity increased to 9.7 billion euros as of December 31, 2023 (previous year: 8.5 billion euros). At 1.7, the leverage ratio, defined as the sum of net debt and net pension liabilities in relation to Adjusted EBITDA, was again significantly lower than the previous year's figure of 2.3. The Lufthansa Group's balance sheet strength was also recognized by global rating agencies. For the first time since the pandemic and as the only European network Airline Group, the Lufthansa Group is now again consistently rated investment grade by all four agencies in the market. Shareholders to participate in profits For the first time since the coronavirus pandemic, shareholders are to participate directly in the company's strong earnings again. The Executive Board and Supervisory Board will propose a dividend of 0.30 euros per share for the 2023 financial year at the Annual General Meeting on May 7, 2024. This corresponds to a dividend yield of around four percent on the year-end share price. The proposed payout follows the Lufthansa Group's dividend policy of distributing between 20 and 40 percent of the Group’s profit to shareholders. Remco Steenbergen, Chief Financial Officer of Deutsche Lufthansa AG: "The strong result for the financial year 2023 is another important step in positioning the Lufthansa Group for the future. Our solid balance sheet and strong free cash flow enable us to make the necessary investments in our fleet and our product. I am convinced that these investments will pay off - for our customers, but also for our shareholders. Over the past three years, I have had the privilege of supporting the company in overcoming the crisis and putting the Group back on a solid financial footing. The Lufthansa Group has set itself the goal of continuing to pursue the path of profitable growth in order to increase the operating margin in the long term and continue to create value in the future. I am particularly pleased that we can once again allow our shareholders to participate in our success by resuming dividend payments." Record investments on the customer side The Lufthansa Group’s customers will also benefit to a large extent from the financially successful year 2023. In 2024, the Lufthansa Group will invest a record sum of around 4.5 billion euros in new aircraft, new seats, lounges, improved culinary and digital offerings in order to significantly increase customer satisfaction. With the new "Allegris" cabins at Lufthansa, and "SWISS Senses" at SWISS, the Lufthansa Group airlines are setting new standards. Lufthansa guests will be able to experience the new features for the first time in May, initially on the connection from Munich to Vancouver (Canada). The focus remains on operational stability, punctuality and improved customer communication. To achieve this, a major service offensive was launched across all passenger airlines in the Group at the beginning of the year. Record for aircraft deliveries The Lufthansa Group is currently undergoing the largest fleet modernization in its history. In 2024, the company will again take delivery of more than 30 new aircraft, including around 20 long-haul jets. A double-digit number of Boeing 787-9 "Dreamliners", eight Airbus A350-900s and one Boeing 777 freighter will be delivered to the company. All these long-haul aircraft will fly for Lufthansa Airlines and Lufthansa Cargo. Never before in our history have we been expecting the delivery of so many new long-haul aircraft for Lufthansa in just one year. In total, the Lufthansa Group currently has over 250 latest generation aircraft on its order list - another record. In the medium term, the modernization will lead to the decommissioning of older sub-fleets, leading to a significant increase in customer comfort as well as a sustainable reduction in CO2 emissions. The significantly more fuel-efficient aircraft consume up to 30 percent less kerosene compared to their respective predecessor models and emit correspondingly less CO2. Lufthansa Group gives employees a share in the company's success With above-average collective wage agreements and variable remuneration, the Lufthansa Group also allows its employees to participate in the positive development of the company's results. Since mid-2022, the company has increased the remuneration of the professional groups at Deutsche Lufthansa AG by over 10 percent. For the past year, the company is paying Lufthansa Group employees profit-sharing payments agreed with the social partners amounting to over half a billion euros. Over 13,000 employees were recruited last year and a further 13,000 recruitments are planned for the current year. Dr. Michael Niggemann, Chief Human Resources Officer and Labor Director of Deutsche Lufthansa AG: "We are proud to be one of the best employers in the industry and want to remain so. Our employees perform exceptionally well every day. That's why we let them share in our economic success. We have significantly increased remuneration since mid-2022. The offers we have made in the current collective bargaining round are also above average. However, they naturally also take our economic performance into account. We face fierce international competition and need economic success - not only for good employment conditions, but also to invest in more fuel-efficient aircraft, new seats and cabin interiors or digital services, for example. We want to grow. However, this is only possible if we are competitive overall and also in terms of labor costs. The uncompromising strikes by the trade union Verdi are damaging our guests, the company and ultimately our employees. We are always open to short-term negotiations with Verdi - however, we bear joint responsibility for finding good solutions. Verdi must suspend strike action and be prepared to enter into constructive negotiations without preconditions." Outlook The Lufthansa Group expects a continued increase in the demand for flight tickets in the current year. Already now demand is high, especially for flights during the Easter and summer vacation periods. Despite the increase in capacity, the load factors booked for the next three months are above last year’s level. The most popular destinations are Spain, Italy, Greece, and other Mediterranean countries. The Lufthansa Group's passenger airlines also experience continued high demand for service to and from North America. Due to the strong demand, the Group is further expanding the capacity offer of its passenger airlines. However, also in 2024, the focus will remain on ensuring stable flight operations in order to further improve regularity and punctuality. For the full year, the Lufthansa Group anticipates an average capacity offer of around 94 percent compared to 2019. This corresponds to a year-on-year growth of around 12 percent. Lufthansa Group revenue is expected to increase significantly in the 2024 financial year. The unit revenues of the passenger airlines are expected to be stable or only slightly below the previous year level, while unit costs are expected to remain stable. Adjusted EBIT for the Passenger Airlines is therefore expected to be on par with the previous year, as is the operating result in the Logistics and MRO segments. The Group's operating result (Adjusted EBIT) is also expected to be on the same level as in 2023. The Group remains committed to its goal of generating a sustainable Adjusted EBIT margin of at least 8 percent. Adjusted free cash flow is forecasted to reach at least 1.5 billion euros. Net capex is expected to amount to 2.5 to 3 billion euros. Higher gross investments will be partly offset by inflows from sale-and-lease-back transactions. In line with the usual seasonality, results will be particularly strong in the second and third quarter of the year. In the first quarter, the Adjusted EBIT loss is expected to be higher than in the previous year, due to the impact of the strikes on earnings and a decline in profits in the Logistics division, which in the first quarter of the previous year still benefited considerably from the exceptionally strong development of the air freight market in connection with the coronavirus pandemic. Transformation into an airline group and internationalization remain focus The Lufthansa Group continues to systematically drive forward its transformation from an aviation group to a global airline group. The sale of the catering business (LSG Group) was completed at the end of October 2023. The company expects the sale of the payment specialist AirPlus to be completed in summer 2024. The Group is also expecting the EU Commission’s approval for an investment in the Italian airline ITA Airways over the course of this year. The Lufthansa Group is working closely and constructively with the EU Commission to achieve a swift conclusion and subsequent implementation of the transaction. With the planned investment in ITA Airways, the Lufthansa Group is driving forward the internationalization of the company in order to make better use of attractive growth opportunities abroad. More than 1 million Green Fare tickets sold The Lufthansa Group remains strongly committed to increasing the availability and use of Sustainable Aviation Fuel (SAF). Lufthansa was the first airline worldwide to start using SAF in regular flight operations back in 2011. In addition, the Lufthansa Group also intends to use innovative solutions for filtering CO2 from the air and storing it underground to offset unavoidable CO2 emissions. The company is expanding its technology partnerships in this area. Already today, the Lufthansa Group is a global leader in offers and services for more sustainable flying. More than one million Green Fares have already been sold on flights in Europe and to North Africa in the first year of the offer. The Lufthansa Group is currently also testing its Green Fares on selected long-haul flights. In addition, more and more corporate customers are taking advantage of the opportunity to offset flight-related CO2 emissions: In 2023, more than 1,500 companies worldwide invested in SAF with the Lufthansa Group. Further information Further information on the results of individual business segments will be published in the annual report. This will be published at the same time as this press release on March 7, 2024 at 7:00 a.m. CET at https://investor-relations.lufthansagroup.com/en/investor-relations.html The annual press conference will be streamed live at http://www.lufthansagroup.com from 9:30 a.m. CET. The analyst call will be streamed live at https://investor-relations.lufthansagroup.com/en/publications/financial-reports.html from 12:30 p.m. CET. The traffic figures for 2023 will also be published at 7:00 a.m. at https://investor-relations.lufthansagroup.com/en/publications/traffic-figures.html
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Slash Announces S.E.R.P.E.N.T.
Following the announcement of his highly anticipated sixth solo album Orgy of the Damned, due out May 17 on Gibson Records, the iconic, GRAMMY®-winning guitarist and songwriter SLASH, has confirmed a North American tour in celebration of the Blues this summer. SLASH’s newly announced S.E.R.P.E.N.T. festival, an anagram that stands for Solidarity, Engagement, Restore, Peace, Equality N’ Tolerance will kick off on July 5 in Bonner, Montana, and travel to Los Angeles, Denver, Cincinnati, Toronto, New York City, Boston, Atlanta, and many more cities. SLASH has curated an all-star Blues lineup to join him on the inaugural S.E.R.P.E.N.T. festival this summer, including Warren Haynes Band, Keb’ ‘Mo, Christone “Kingfish” Ingram, Robert Randolph, Samantha Fish, Eric Gales, ZZ Ward, Jackie Venson, and Larkin Poe. On all dates, SLASH will perform alongside his Blues band featuring bassist Johnny Griparic, keyboardist Teddy ‘ZigZag’ Andreadis, drummer Michael Jerome, and singer/guitarist Tash Neal. SLASH formed the S.E.R.P.E.N.T. festival which stands for Solidarity, Engagement, Restore, Peace, Equality N’ Tolerance to bring fans together to celebrate the spirit of the Blues, and to perform with other Blues artists he admires who share his love of the genre. SLASH also has a strong desire to give back to charities that he has supported over the years, as well as to help lift marginalized communities that share his restorative focus of elevating lives for the benefit of all. A portion of the proceeds from each VIP package and S.E.R.P.E.N.T. festival ticket sold will directly benefit the following charities that SLASH has selected The Equal Justice Initiative, Know Your Rights Camp, The Greenlining Institute, and War Child. S.E.R.P.E.N.T Festival has partnered with PLUS1.ORG to support these charitable endeavors. “The S.E.R.P.E.N.T. tour is a celebration of blues and rock ‘n’ roll music, and a celebration of unity and togetherness in these uncertain and divisive times,” says SLASH. “S.E.R.P.E.N.T is a vehicle to help support and uplift people and communities suffering from the injustices of racism and equal rights violations, as well as to support children adversely affected by war and poverty across the world. So, we are contributing a portion of every ticket and VIP package sold from the tour to those ends. S.E.R.P.E.N.T. will also provide an environment where folks can get together for a day of great music and hang out and have a good time.” General on sale for tickets begins Friday, March 15 at 10am local time. For pre-sales, visit www.serpentfestival.com. A limited number of S.E.R.P.E.N.T. festival VIP packages are available now which include access to watch SLASH’s soundcheck before the show, hand-signed vinyl of Orgy of the Damned, and more, go to: www.serpentfestival.com. S.E.R.P.E.N.T Blues Festival 2024 North American Dates: * Warren Haynes Band, Samantha Fish, and Eric Gales ** Keb’ ‘Mo, Samantha Fish, and Jackie Venson # Keb’ ‘Mo, ZZ Ward ,and Jackie Venson $ Keb’ ‘Mo, ZZ Ward, and Robert Randolph ^ZZ Ward and Robert Randolph + Larkin Poe, ZZ Ward, and Robert Randolph ^^Christone “Kingfish” Ingram, ZZ Ward, and Robert Randolph SLASH’s Orgy of the Damned cover art. SLASH’s star-studded debut blues album, Orgy of the Damned, is a collection of 12 dynamic songs that shakes up and revitalizes blues classics with a stripped-down, instinctive approach, creating a singular expression that pays homage to the blues. Celebrating both well-known and largely undiscovered songs, SLASH offers a nostalgic nod to the past while reinvigorating the songs with his inimitable guitar playing and the spirit of collaboration. For Orgy of the Damned, the acclaimed guitarist reteamed with storied producer Mike Clink and enlisted the album’s diverse guest vocalists, which include Gary Clark Jr, Billy F. Gibbons, Chris Stapleton, Dorothy, Iggy Pop, Paul Rodgers, Demi Lovato, Brian Johnson, Tash Neal, Chris Robinson, and Beth Hart, in a similar way to his 2010 self-titled solo LP Slash. Rounding out his band in the studio and on the road, SLASH reunited with two of his bandmates from his Blues Ball outfit in the 90s, bassist Johnny Griparic and keyboardist Teddy ‘ZigZag’ Andreadis, and brought on drummer Michael Jerome and singer/guitarist Tash Neal. The first single “Killing Floor,”--which features Brian Johnson of AC/DC on vocals, and Steven Tyler of Aerosmith on harmonica--is an electrifying, raucous and gleefully unbridled take on Howlin’ Wolf’s 1964 Chicago blues standard; stream “Killing Floor,” now HERE. Watch/share the new video for “Killing Floor,” which offers a first look at SLASH and his Blues band recording the song in the studio HERE. Although he grew up in England, SLASH’s American grandmother turned him on to the blues early on, and he was immediately taken with B.B. King. At the same time, his parents raised him on a healthy diet of 60s British rock ‘n’ roll, from The Who to The Kinks. Once he moved to Laurel Canyon, SLASH found himself surrounded by rock and folk singers like Joni Mitchell, Crosby, Stills & Nash, and Neil Young—all of whom eventually inspired his playing and songwriting. It wasn’t until he began playing guitar himself that SLASH realized all of his favorite musicians had been influenced by the same B.B. King blues records he’d listened to as a young kid. Orgy of the Damned encompasses a broad range of styles within the blues genre, veering from an upbeat, rowdy take on Robert Johnson’s “Crossroads” to a plaintive, twanging rendition of T. Bone Walker’s “Stormy Monday.” Some of the songs, like Steppenwolf’s “The Pusher,” Charlie Segar’s “Key to the Highway,” and Albert King’s “Born Under a Bad Sign,” had been performed by Slash’s Blues Ball, while others, like Stevie Wonder’s “Living for the City,” were long-time favorites for SLASH. “Hoochie Coochie Man,” written by Willie Dixon and made famous by Muddy Waters in 1954, showcases the in-the-moment nature and unrestrained energy of Orgy of the Damned, with Z.Z. Top’s Billy F. Gibbons stepping in on guitar and vocals. The group went into a rehearsal room in North Hollywood and began hashing out soulful, rollicking takes on the classic songs. Everything was played live in the room, with an emphasis on improvisation which resulted in a collection of dynamic, energized songs that are immediate, raw, and distinctly familiar. A vibrant homage to the Blues, Orgy of the Damned is a landmark moment in SLASH’s career and a rare opportunity to bring to the forefront a rollicking musical journey through his Blues inspirations that have long been in the background of his illustrious career. SLASH’s Orgy of the Damned is available digitally, on vinyl and CD via Gibson Records for pre-order https://gibsonrecords.lnk.to/ootd Preview the album https://gibsonrecords.lnk.to/killingfloor , and for more information, go to www.slashonline.com
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Colourful Public Art Show – “Planet Walala @Harbour City”
In Hong Kong Arts Month, Harbour City has invited the renowned French artist Camille Walala to create the Colourful Public Art Show “Planet Walala @Harbour City” from 21 March to 21 April. The three major highlights include two large public installations and a solo art exhibition, all interacting with the public in different ways. The first-ever Hong Kong City Sign “Now You See It Now You Don’t” as a brand-new permanent artistic landmark, together with the outdoor artistic maze “A-MAZE”, will be displayed at Ocean Terminal Deck alongside the iconic Victoria Harbour. Meanwhile, Camille will host her first solo art exhibition “Metropolis” at Gallery by the Harbour to showcase the charisma of colours. In addition, Harbour City will organize a series of extensive and thrilling art activations targeting a wide range of audiences throughout the campaign. Camille Walala, a multi-disciplinary artist based in London, is well-known for her artworks encompassing full-facade murals, immersive 3D installations, street art, interior and set design – all characterized by a fusion of bold colours and playful geometric patterns. Being in awe of the architecture in Hong Kong, Camille incorporated geometrics found in the cityscape into the City Sign and the Maze, bringing connectivity between people and the locality. More than just a photogenic spot, the installations inspire happiness and spark positivity with the design of joyful colours. - First-ever Hong Kong City Sign, the Brand-new Artistic Landmark and Photo Spot Numerous famous tourist destinations around the globe have their own city signs as an iconic landmark, such as “I Seoul U” in South Korea, “TORONTO” in Canada, and “HOLLYWOOD” in the U.S., all serving as popular photo spots for visitors and a highlight of their journey. This year, Harbour City invited Camille Walala to design the first-ever Hong Kong City Sign, titled “Now You See It Now You Don’t”, which stands at a height of 3m and stretches a width of 6.5m. From the perspective of a foreign tourist, in the eyes of both an artist and a designer, Camille has outlined the unique silhouette of the city. With the blue of the Harbour as its primary tone, the City Sign echoes with the cityscape in various ways, including the overlapping sculptural letters resembling the dense skyline and the tile-like texture in parallel with the mosaic tiles found in old buildings. Drawing influence from optical artworks by George Rousse, Camille adopted an anamorphic approach to the design of the art piece. Though each sculpture stands alone as a beautiful object, people can only read the letters of “HONG KONG” from a certain point of view, giving the City Sign its name “Now You See It Now You Don’t”. - Be Amazed at “A-MAZE”, the Playful Maze that Brings People the Joy of Discovery As an evolution of Walala x PLAY, an immersive maze created for Now Gallery in London, “A-MAZE” is Camille’s first outdoor maze. Like the City Sign, “A-MAZE” resonates with the landscape of Hong Kong and is a repository of various structural forms. It is not only an art installation, but also a playground and a public open space. Spanning an area of 3,500 sq ft, the fascinating vibrant maze is equipped with seating, allowing people to pause, reflect, and soak up the spectacle around them. Through “A-MAZE”, Camille hopes visitors tap into the state of playfulness, joy, and discovery that we experienced as a child. In addition to the public art installations, Camille’s first solo exhibition “Metropolis”, along with a series of thrilling art activities, will take place during the public art show. Further details will be announced soon. - Camille Walala’s Previous Art Installations and Collaborations Throwing Shade (2023) Concentrical Festival Logroño, Spain Ice and a Slice (2022) XNA National Airport Bentonville, Arkansas, U.S. House Of Dots (2020) Lego X Walala London, United Kingdom Les Jumeaux (2020) White City Place London, United Kingdom Walala Lounge (2019) London Design Festival London, United Kingdom Mural in Industry City (2018) WantedDesign Brooklyn New York City, Washington, U.S. - We cordially invite you to the Media Preview of “Planet Walala @Harbour City”: Date : 20 March 2024 (Wednesday) Time : 2pm – 5pm Meet-up Location : Ocean Terminal Deck Content : Camille will travel to Hong Kong and attend the media preview to share her design concept. Remarks : Please RSVP the Preview on or before 19 March 2024. Media are welcomed to schedule individual face-to-face interviews with Camille on 21 and 22 March. - Hong Kong City Sign – “Now You See It Now You Don’t” Date: From 21 March 2024 Time: 10am – 10pm Venue: Ocean Terminal Deck - Artistic Maze Installation – “A-MAZE” Date: 21 March – 21 April 2024 Time: 10am – 10pm Venue: Ocean Terminal Deck - Camille Walala’s Solo Art Exhibition – “Metropolis” Date: 21 March – 21 April 2024 Time: 11am – 10pm Venue: Gallery by the Harbour (Shop 207, Level 2, Ocean Centre, Harbour City) Customer Enquiry: (852) 2118 8666 / www.harbourcity.com.hk
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Epiphone Partners With Dave Grohl to Release His Legendary Dave Grohl DG-335, Available Worldwide Today
For 150 years, Epiphone has been a leading innovator in instrument design. By leveraging its iconic past and leaning into the future, Epiphone has set the stage for the next era of sound for present and future generations. Epiphone is proud to unveil its global partnership with Dave Grohl. The Dave Grohl DG-335 pays tribute to the longtime six-string mainstay of Dave’s world-spanning tours with the Foo Fighters. As part of the Epiphone Inspired by Custom Collection, the guitar continues a new era of premium features for Epiphone, including high-quality electronics and design upgrades. The Epiphone Dave Grohl DG-335 is now available at Authorized Epiphone dealers and worldwide on www.epiphone.com A longtime Gibson user, Dave’s previous Gibson signature guitars have remained extraordinarily popular and continue to command premium prices on the used market. Epiphone is proud to once again partner with Gibson Custom on the release of the Dave Grohl DG-335. It features the combination of ES-335 and the Trini Lopez model features Dave requested and that fans expect, including a semi-hollow ES™ body made of layered maple/poplar, with bound diamond-shaped sound holes, a one-piece mahogany neck with an elliptical C profile, a Trini Lopez style headstock with Grover® Mini Rotomatic® tuners, a laurel fretboard, and split diamond inlays. The pickups are Dave’s preferred Gibson USA Burstbucker™ models, with a Burstbucker 2 in the neck and a Burstbucker 3 in the bridge position. They’re wired to CTS® potentiometers, Mallory™ capacitors, and a Switchcraft® 3-way toggle switch and 1/4” output jack. The Dave Grohl DG-335 is one of the most requested models in Epiphone’s history, and Epiphone is X-Static to offer this exceptional guitar to players worldwide. An Epiphone Dave Grohl hardshell case is also included. Foo Fighters will resume their Everything or Nothing at All global stadium tour on May 1 in Dallas, TX. The tour takes its name from the chorus of “Nothing at All,” from Foo Fighters’ universally acclaimed 11th album But Here We Are. Released June 2, 2023 on Roswell Records/RCA Records, But Here We Are has garnered some of the best critical notes of the band’s storied career, while its singles “Rescued” and “Under You” have cemented the band’s tally of more #1s than any other artist on Rock and Alternative Radio. For all Foo Fighters tour dates, visit: https://foofighters.com/tour-dates/
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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. 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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