Category: 3. Business

  • Fintech can be catalyst to make Hong Kong a next-level financial hub: Broadridge CEO

    Fintech can be catalyst to make Hong Kong a next-level financial hub: Broadridge CEO

    Embracing technology platforms for applications such as electronic proxy voting, private debt underwriting and trading of repurchase (repo) agreements can help Hong Kong elevate its standing as Asia’s top financial hub, according to a leading US fintech firm.

    Technologies that simplified investor engagement had been a catalyst for growth in other markets, said Tim Gokey, CEO of New York-listed Broadridge Financial Solutions, adding that fintech could enhance corporate governance and product innovation to help the city strengthen its connections with mainland China and the wider world.

    “We’re investing in the region and are excited to be part of the rapidly growing Hong Kong market, which is emerging as a leading financial hub in Asia and the primary point of connectivity between the mainland and global markets,” Gokey said in an interview during a trip to the city last month.

    Do you have questions about the biggest topics and trends from around the world? Get the answers with SCMP Knowledge, our new platform of curated content with explainers, FAQs, analyses and infographics brought to you by our award-winning team.

    His comments came before financial regulators in Hong Kong and mainland China unveiled a series of measures last month to allow cross-boundary bond repo business and to strengthen the city’s fixed income and currency markets – all initiatives that had been discussed and anticipated among market participants for a number of years.

    “We see a strong opportunity to support that growth by enhancing trust and transparency in corporate governance,” added Gokey, whose firm doubled its Asian team to nearly 500 over the past five years, with Hong Kong accounting for more than 80 people.

    As companies increasingly turned to capital markets, beyond banks, for fundraising, the transparency and trust of corporate governance became essential, he said, pointing to the US as an example.

    Tim Gokey, CEO of New York-listed Broadridge Financial Solutions. Photo: Handout alt=Tim Gokey, CEO of New York-listed Broadridge Financial Solutions. Photo: Handout>

    “Strong corporate governance is one of the key drivers behind the success and confidence in US capital markets,” he said. “It’s not the sole answer, but a crucial contributing factor.”

    Broadridge’s corporate-governance offerings, including proxy-voting platforms, have a global reach, processing shares held in street names at more than 1,000 broker-dealers and custodian banks. Its proxy services covered about 80 per cent of outstanding shares of US publicly listed companies in 2023.

    “Leveraging technology to simplify investor engagement has fuelled growth in markets like Japan, and building similar trust and transparency in Hong Kong is vital for its ambition to enhance connectivity between the mainland and the rest of the globe and become Asia’s leading financial hub,” Gokey said.

    A pain point that Broadridge aims to address is improving the distribution of information on corporate-governance processes, which was often well documented but not effectively shared.

    Digitising materials and enabling convenient access and voting through an app or broker platform would make it easier for retail investors to engage with the companies they invested in, he said.

    “Our platform brings transparency and enables retail investors – particularly those using digital brokers in Hong Kong who may hold shares across China, the US and Europe – to conveniently vote their shares globally under different regulatory regimes,” he said.

    For institutional investors, the firm was developing a data-driven voting platform that used artificial intelligence to apply preset rules to votes, moving beyond traditional recommendation-based systems to make proxy voting more efficient and customised, Gokey said.

    Another focus area for Broadridge in Asia is private debt – a growing asset class in the region. The firm’s cloud-based platform aimed to help asset managers with tasks from underwriting and working through deals to keeping deals on their books and record-keeping, reducing risks associated with managing collateralised loan obligations.

    Gokey said the fintech company also saw opportunities in tokenised assets and their clearing and settlement in Hong Kong, as market conditions and regulatory initiatives increasingly aligned with participants’ needs.

    Hong Kong authorities have launched several plans to future-proof the city’s financial infrastructure in recent years, including initiatives like stablecoins, electronic trading platforms and tokenised products.

    “We believe [our solution] is well-suited for this market due to clients’ need for liquidity, financing and risk management, as well as regulators’ push for digital assets,” Gokey said. “By leveraging existing infrastructure, we can help jump-start repos on the distributed ledger in Hong Kong and build confidence around these instruments.”

    This article originally appeared in the South China Morning Post (SCMP), the most authoritative voice reporting on China and Asia for more than a century. For more SCMP stories, please explore the SCMP app or visit the SCMP’s Facebook and Twitter pages. Copyright © 2025 South China Morning Post Publishers Ltd. All rights reserved.

    Copyright (c) 2025. South China Morning Post Publishers Ltd. All rights reserved.


    Continue Reading

  • Meet AMIES, China’s new hope in breaking reliance on ASML’s chipmaking machines

    Meet AMIES, China’s new hope in breaking reliance on ASML’s chipmaking machines

    AMIES Technology, a new Chinese lithography equipment manufacturer that showcased its latest chipmaking products at an industry event in Shenzhen last week, is offering renewed optimism in the nation’s drive to reduce its dependence on Dutch giant ASML.

    The company presented a wide range of products – including compound-semiconductor lithography machines, laser-annealing systems, advanced inspection tools and solutions for packaging and wafer bonding – at the WeSemiBay Semiconductor Ecosystem Expo 2025, which featured more than 600 exhibitors, such as Huawei Technologies partner SiCarrier.

    Advanced lithography remains a significant bottleneck in China’s chipmaking ambitions. The country still trails far behind global leaders in the technology and is restricted from acquiring ASML’s top deep ultraviolet (DUV) and extreme ultraviolet (EUV) systems due to US export controls.

    Do you have questions about the biggest topics and trends from around the world? Get the answers with SCMP Knowledge, our new platform of curated content with explainers, FAQs, analyses and infographics brought to you by our award-winning team.

    Founded in February, AMIES is a spin-off from China’s leading lithography company, the state-owned Shanghai Micro Electronics Equipment (SMEE). While SMEE focuses on developing essential front-end tools, AMIES aims to commercialise equipment more swiftly, according to Chinese media reports, citing company representatives.

    US-sanctioned SMEE excels in back-end semiconductor processes like packaging, which often require less advanced lithography technology. When it comes to front-end wafer fabrication, however, it is still trying to catch up with Western leaders such as ASML.

    AMIES was spun off from SMEE in February. Photo: Handout alt=AMIES was spun off from SMEE in February. Photo: Handout>

    The Chinese company’s most reliable production-grade lithography tools are believed to support processes around 90-nanometre node and above. In late 2023, its shareholder Zhangjiang Group briefly claimed on social media that SMEE had “successfully developed a 28-nm lithography machine”, but later retracted the reference.

    In contrast, ASML’s EUV systems are used by leading chipmakers for processes at 2-nm nodes and below.

    For now, AMIES said its flagship product is its advanced packaging lithography machine, which held a global market share of 35 per cent and a 90 per cent share in China.

    On its website, AMIES lists four product lines: integrated circuits, advanced packaging, compound semiconductors and flat-panel displays. These encompass various types of annealing, inspection, chip manufacturing and packaging tools.

    In August, the company said it shipped its 500th stepper lithography machine. Steppers expose chip patterns on wafers one section at a time, unlike scanners, which continuously move the mask and wafer for faster, more precise exposures.

    AMIES received an award at the China International Industry Fair in September for its “next-generation fan-out packaging lithography system”.

    The company has received solid state support. AMIES’s nearly 30 shareholders include local government-backed funds such as Shanghai Information Investment, Spinnotec, the venture arms of Zhangjiang Hi-Tech Park and Citic Group, alongside a number of private equity investors, according to the Chinese corporate database Tianyancha.

    AMIES said it had a technical team of 600 people, with an average age of 33, and 65 per cent holding master’s or doctoral degrees.

    As part of China’s broader push for chip self-reliance across the supply chain, various players are racing to develop domestic DUV and EUV tools. Shenzhen-backed chip equipment firm SiCarrier, for example, is reportedly working on advanced-node lithography machines, although it has not publicly unveiled such products.

    Zetop Technologies – partially owned by SiCarrier and the US-sanctioned Changchun Institute of Optics, Fine Mechanics and Physics under the Chinese Academy of Sciences – counts key EUV optics researchers among its shareholders.

    Shanghai-based Yuliangsheng, in which SiCarrier also has a stake, supplied a 28-nm DUV system to Semiconductor Manufacturing International Corporation, China’s largest semiconductor foundry, for testing in 7-nm chip production, according to a Financial Times report in September.

    In the third quarter, ASML reported total net sales of €7.5 billion (US$8.8 billion), with China accounting for 42 per cent of system orders.

    However, ASML expected a sharp decline in demand from China next year, as tensions between the US and China, coupled with Beijing’s recent export controls on rare earth materials essential for ASML’s machines, have further complicated the global semiconductor supply chain.

    This article originally appeared in the South China Morning Post (SCMP), the most authoritative voice reporting on China and Asia for more than a century. For more SCMP stories, please explore the SCMP app or visit the SCMP’s Facebook and Twitter pages. Copyright © 2025 South China Morning Post Publishers Ltd. All rights reserved.

    Copyright (c) 2025. South China Morning Post Publishers Ltd. All rights reserved.


    Continue Reading

  • How Investors May Respond To Aeluma (ALMU) Boosting Growth Funds With $25 Million Capital Raise

    How Investors May Respond To Aeluma (ALMU) Boosting Growth Funds With $25 Million Capital Raise

    • Aeluma, Inc. recently completed its underwritten public offering, raising approximately US$25.4 million in gross proceeds and boosting its cash position to about US$38 million to invest in manufacturing partnerships and engineering talent.

    • This significant cash increase could further position Aeluma for operational expansion through new hires and enhanced manufacturing capabilities.

    • To assess how these developments affect Aeluma’s investment narrative, we’ll focus on the company’s increased capacity to invest in growth initiatives.

    Uncover the next big thing with financially sound penny stocks that balance risk and reward.

    To own shares in Aeluma today is to believe the company can turn rapid revenue growth and cutting-edge photonics into lasting profitability, even in a competitive and volatile sector. The recent US$25.4 million public offering lifts Aeluma’s cash reserves to around US$38 million, giving the company more room to pursue manufacturing partnerships and attract engineering talent. This extra cash could accelerate key short-term catalysts like new product launches and customer wins, while potentially reducing worries about near-term funding pressures. Still, with a recent uptick in insider selling and a history of substantial shareholder dilution, questions remain about how quickly the business can transition from high growth to sustainable profit. The fresh cash raises the company’s ceiling for expansion, but does not remove risks around execution, dilution, or path to profitability. In contrast, investors should keep an eye on the ongoing dilution risk and shifting capital needs.

    Our valuation report unveils the possibility Aeluma’s shares may be trading at a premium.

    ALMU Community Fair Values as at Oct 2025

    Opinions from 4 Simply Wall St Community members peg Aeluma’s fair value anywhere from US$1.58 to US$25.50 per share. With such a wide range of estimates and the company recently strengthening its cash reserves, views on Aeluma’s future profitability and dilution risk continue to divide market participants. Explore these different viewpoints to better understand both the opportunity and the uncertainty.

    Explore 4 other fair value estimates on Aeluma – why the stock might be worth as much as 53% more than the current price!

    Disagree with this assessment? Create your own narrative in under 3 minutes – extraordinary investment returns rarely come from following the herd.

    Don’t miss your shot at the next 10-bagger. Our latest stock picks just dropped:

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include ALMU.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

    Continue Reading

  • XYMAX REIT Investment (TSE:3488) Margin Gain Reinforces Defensive Narrative Despite Dividend Concerns

    XYMAX REIT Investment (TSE:3488) Margin Gain Reinforces Defensive Narrative Despite Dividend Concerns

    XYMAX REIT Investment (TSE:3488) delivered a 9.1% increase in earnings this year, building on a robust 5.5% annual growth rate over the past five years. Net profit margins ticked up to 50% from 48.5% last year. High-quality earnings further underpin this performance. With the company recognized for strong value and consistent profit growth, investors are weighing improving profitability against lingering questions about the balance sheet and dividend sustainability.

    See our full analysis for XYMAX REIT Investment.

    Next, we will see how these results compare with market expectations and popular narratives, highlighting where reality and market perception may diverge.

    Curious how numbers become stories that shape markets? Explore Community Narratives

    TSE:3488 Revenue & Expenses Breakdown as at Oct 2025
    • Net profit margin improved from 48.5% to 50% year-on-year, underscoring that profitability is trending higher rather than just staying stable.

      • Strong margins heavily support the claim that XYMAX REIT’s consistent distribution track record and occupancy stability make it attractive for investors seeking yield and income reliability.

      • At the same time, the modest margin jump clarifies this performance comes without aggressive moves, reinforcing the view that stability is a central pillar instead of rapid growth.

    • Prevailing market view emphasizes how the firm’s margin resilience signals a defensive profile, fitting investor appetites for safety amid modest economic recovery and sector caution.

      • This supports the idea that steady, high margins can justify a valuation premium during market risk aversion, even when aggressive expansion is not on the table.

      • However, with only a slight margin uptick, the company may underwhelm those looking for more dynamic, growth-driven upside.

    • The current Price-To-Earnings ratio is 17x, lower than both the JP REIT industry average (20.2x) and peer average (17.7x). However, the share price of ¥119,700 exceeds the estimated fair value of ¥113,923.04.

      • Prevailing market view notes that while XYMAX REIT appears a bargain relative to sector multiples, buyers are paying a small premium above fair value for its perceived income stability.

      • This contrast highlights a trade-off: the REIT trades at a discount to peers but not to its intrinsic worth, so some caution is warranted if broader market risk appetite returns or sector leaders begin to grow faster.

    • Even with this valuation setup, the share price may reflect a safety premium, especially when steady distribution and high margins outweigh the lack of visible growth initiatives.

      • As sector conditions remain cautious and income predictability is prized, this valuation standoff could persist until a clear catalyst tips sentiment toward value or growth.

      • Investors looking for deep value should be mindful that the stock does not currently trade below fair value, despite its discounted P/E multiple.

    Continue Reading

  • ‘Disorder, fright and confusion’: looking back at the devastating Wall Street crash of 1929 | Books

    ‘Disorder, fright and confusion’: looking back at the devastating Wall Street crash of 1929 | Books

    Andrew Ross Sorkin’s first book, Too Big to Fail, was a bestseller about the financial crisis of 2008, published the following year. His second, 1929, out this week, takes readers “Inside the Greatest Crash in Wall Street History – and How it Shattered a Nation”.

    It’s been 16 years between books, but Sorkin hasn’t been idle. A columnist for the New York Times, he founded its DealBook newsletter and summit; he’s a Squawk Box co-anchor for CNBC; and after Too Big to Fail was filmed by HBO, he co-created Billions, a huge hit for Showtime starring Damian Lewis and Paul Giamatti.

    After Too Big to Fail, Sorkin said, he was “often asked about 1929. I actually didn’t know much. I had read JK Galbraith [The Great Crash, 1929, published in 1955] and a couple other books. And most people I knew, we would all sort of talk about 1929 as this terrible calamity, but nobody … knew what actually happened – who the people were, what they said to each other, what the motivations were, what the incentives were, what the lessons actually were.”

    The short version of what happened in 1929 is that a stock market built on fast credit and wild speculation suffered a series of falls culminating in the Black Thursday crash on 24 October, in Galbraith’s words a day “measured by disorder, fright, and confusion”.

    Combined with factors including protectionist tariffs and rising unemployment, the crash was a key signpost to a devastating global depression.

    “About a decade ago,” seeking a way into the story, Sorkin went on vacation and “like a real nerd, downloaded some books to a Kindle … and I remember reading them, thinking: ‘Wow, this is so much more interesting than I knew,’ but also feeling most of the books about this period were written in the 1930s, some in the 40s, 50s. I think there’s one that was maybe the 70s. And a lot of them were written by economists … told through charts and data and economic systems. And I wanted the human drama.

    The cover of 1929. Photograph: Viking/Penguin

    “One of the lessons of writing Too Big to Fail was, we talk about business and the economy oftentimes in big numbers and structures and systems, but it really is ultimately about people and the decisions they make. So I thought: ‘Maybe there’s an opening to write a book like that.”

    A visit to Harvard allowed a look at the papers of Thomas Lamont, a partner at JP Morgan, including transcripts of White House talks with President Herbert Hoover. Allowing for myriad commitments and the challenges of pandemic-era research, Sorkin’s book was a go.

    As influences for a book based on first-hand sources found in countless archives, Sorkin cites business classics: Den of Thieves by James B Stewart, about insider trading; Liar’s Poker by Michael Lewis, about bonds traders; and Barbarians at the Gate by Bryan Burrough and John Helyar, about the fall of RJR Nabisco.

    “Widening the aperture”, a phrase Sorkin uses to describe a project that encompasses earlier panics (1907, 1921) and the long aftermath of 1929, he also looked to Walter Lord’s A Night to Remember, from 1955, as “really the definitive in-the-room account of the sinking of the Titanic” and “actually a little bit like a mental model … [for] a way I wanted the reader to be able to feel.”

    The crash of 1929 was indeed like a shipwreck. Livelihoods were lost when the market capsized, though Sorkin confirms that one image in the popular imagination, of ruined brokers leaping from Wall Street windows, is not what actually happened. For a while, it seemed the economy might recover. It took other factors, prominently including the Smoot-Hawley Tariff Act of 1930, to bring about depression.

    As Sorkin’s book comes out, Donald Trump’s tariffs and their effects are in the news. Sorkin said he wrote with an eye on current events but preferred not to oversell such parallels, instead seeking chiefly to present relatable characters.

    “I’m always trying to understand where the drive comes from, where the motivation comes from, for whatever the decision is that people are making,” Sorkin said, citing experience gained “in the context of Billions and the making of the movie Too Big to Fail” as well as “what I try to do with my journalism every day.

    “Oftentimes it was to try to understand: ‘Well, what is it that’s driving Charlie Mitchell?’ … or: ‘What was it about Carter Glass in his childhood that led him to be this sort of very unique character?’ Similarly with Lamont and John Raskob and so many others.”

    The front page of the Brooklyn Daily Eagle newspaper. Photograph: Icon Communications/Getty Images

    Mitchell, CEO of National City Bank, a casualty of the crash, was hauled before Congress and into court on tax charges. Glass was a senator from Virginia who drove reform to protect ordinary Americans from Wall Street excess. Raskob, an executive at DuPont and General Motors, chaired the Democratic National Committee.

    One way Sorkin seeks to make such characters relatable is to depict their use of technology to master fast-moving markets – analog telephones in serried ranks on desks above Wall Street now home to computers. He’s also happy to compare key players to equivalents today.

    Considering Glass, a Virginia conservative, Sorkin looks to a current senator from Massachusetts, decidedly more progressive, the force behind the Consumer Financial Protection Bureau, formed after 2008 to protect ordinary investors.

    “If Elizabeth Warren was a racist, that’s who [Glass] would be,” Sorkin laughed. “But what, to me, was so interesting about [Glass] was also that … he was cited after the 2008 financial crisis as one of the great bastions of the regulatory world. I think liberals really loved him. They thought that he was really trying to hold Wall Street to account.

    “And I went into this project thinking about that narrative, and … as the story progresses, it is so much more complicated than that. I’m not sure Elizabeth Warren would be citing Carter Glass today if she really understood the full dynamic of how the Glass-Steagall Bill was created.

    “I thought of Glass-Steagall [also named for Henry B Steagall, a congressman from Alabama] as this famous bill that broke up the banks and was really meant to end the casino [gambling on the markets], and then you realize … the real movers weren’t even politicians, to some degree they were bankers who were trying to screw each other. And maybe it just represents how this world is actually no different than it is today, in many ways, in terms of how the sausage gets made.”

    Among those bankers, Sorkin found Mitchell “sort of a villain, but not really” and compelling because “I love characters that are not black and white. And he was so interesting to me because he was as famous as Jamie Dimon [CEO of JPMorgan Chase] would be today. But there were aspects of [Mitchell] that might have been more like a Michael Milken,” the insider trader jailed in 1990 then pardoned by Trump in 2020.

    “Charlie Mitchell created credit and leverage in the system to loan money to ordinary investors, which in large part is what led to the crash. Michael Milken revolutionized the debt markets and the credit markets in the 80s by loaning high-yield bonds, or what people call junk bonds, to less good credits. And they both were arrested. The outcome was slightly different, but they were both hated.”

    Knowing today’s titans well – it was his question that memorably prompted Elon Musk to tell critics “go fuck yourself” – Sorkin is well placed to make comparisons. Regarding another key character in 1929, the Tesla, SpaceX and X owner duly enters the chat.

    Andrew Ross Sorkin. Photograph: Mike Cohen

    “To me, John Raskob is like Elon Musk. Think about a businessman who was involved in everything. Cars, obviously, General Motors, and [Raskob] gets involved in politics … starting to try to damage the reputation of Hoover by doing all of these back-channel projects. And then he’s building the equivalent of a spaceship, the Empire State Building. And he also happens to have 13 children.”

    Among the supporting cast, there’s Hoover, the technocratic president who rebranded the post-crash “panic” as a “depression”, inadvertently sealing his reputation as a failure, left to watch Franklin D Roosevelt save the day. Sorkin also depicts Winston Churchill, a decade away from his finest hour as British prime minister, in debt to his shirtmaker, playing the Manhattan markets anyway, wandering Fifth Avenue, there to be hit by a car.

    Financial calamity brings political fallout. In the second half of 1929, Sorkin’s story moves to Washington and attempts to hold Wall Street accountable. As in 2008, most main players avoided serious penalties.

    Clearly, Sorkin is going to get more questions about what 1929 might teach us about 2025 and a US economy showing signs of trauma, Trump-induced or not.

    He said: “There are a lot of parallels that I imagine people could draw out. I mean, look at the idea today and the idea back then of democratizing finance.”

    In 1929, “democratizing finance” meant opening the markets to ordinary Americans through unchecked credit.

    “Today,” Sorkin said, “what do they talk about democratizing finance? They just passed a bill that Trump signed that’s going to allow private equity and venture capital and private credit into your 401(k) plan. That’s all about democratizing finance. Crypto is now a thing that’s about democratizing finance. Obviously, the tariffs are almost a super-direct parallel.”

    Another Trump obsession, bending the central bank to his will, is also foreshadowed in Sorkin’s book.

    “There’s the whole debate the Fed is having in the spring of 1929 about whether to raise or lower interest rates,” Sorkin said. “To some degree, [there are] even debates about the independence of the Fed … So I think there’s lots of things that do seem familiar.”

    Continue Reading

  • Trump’s tariffs are brewing trouble for local coffee roasters

    Trump’s tariffs are brewing trouble for local coffee roasters

    The rising costs of coffee beans are keeping roasters and their customers on edge.

    Retail coffee prices jumped nearly 21% in August compared to the same time last year, and the Trump administration’s tariffs are partially to blame: In July, Brazil was slapped with one of the highest duties, at 50%, while Vietnam has 20% tariffs and Colombia has 10% tariffs.

    America imports more than 99% of its coffee, according to the National Coffee Association. Most of it comes from Brazil — 30.7% of US coffee imports based on net weight, according to the UN Comtrade Database — Colombia (18.3%) and Vietnam (6.6%).

    The average price of regular coffee at restaurants in August was 10 cents more than the same time last year, according to data from Toast, a restaurant management software provider. The increase brought the average price to $3.52.

    Some relief may be on the way. In September, Rep. Don Bacon, a Republican from Nebraska, and Democratic Rep. Ro Khanna of California, introduced the bipartisan “No Coffee Tax Act” to exempt coffee products from tariffs.

    Price hikes may cause some consumers to start brewing their coffee at home, but they will likely continue buying cups from local shops as occasional indulgences.

    “(Consumers) may change brands, or they may shop for deals, or perhaps go down in quality — or what they perceive as a quality level — in order to save a little bit of money,” said Erin McLaughlin, a senior economist at the Conference Board, a nonprofit research group.

    Coffee drinkers in the nation’s capital are seeing more expensive drip and espressos these days. According to data from Toast, a regular hot coffee in Washington, DC, averaged $4.21 in August, up 4% from last year. And the average price of a cold brew costs $5.35, up 3.7% year-over-year.

    Swing’s Coffee Roasters, which was founded in 1916 and has three locations in Virginia and Washington, DC, has been hit with higher-than-usual costs. Owner Mark Warmuth told CNN that Trump’s tariffs caused a “really difficult situation across the board” when combined with environmental and labor factors that make coffee more expensive.

    “Consumers are footing the bill for it,” Warmuth said, adding that “the only loser here is the consumer.”

    The cost of a single cup could go up about 10 or 15 cents, Warmuth warned. Even if importing beans costs 50% more, it’s unlikely a single cup would also increase 50%.

    DC coffee drinkers may wince at the price, but they aren’t likely to give up their caffeine fix.

    Swing's Coffee Roasters in Washington, DC, faces uncertainty about the implementation of Trump's tariffs.

    “(Coffee is) kind of considered an affordable luxury. While it might go from $3 a cup to $3.50 a cup, that may not be enough in downtown DC to cause somebody to change their consumption habits,” he added.

    Chris Vigilante, owner of Vigilante Coffee Company, which has two locations in California and Maryland, said an average pound of coffee has gone up from about $4 to as much as $6. And a 12-ounce bag of beans could increase by 50 cents to $1 for customers, he said.

    Vigilante imports much of its coffee from Brazil, and other beans come from countries including Indonesia, Ethiopia and Colombia. Amid federal layoffs and other pressures affecting DC residents, he said Vigilante Coffee Company has considered importing coffee from other countries to “diversify our offerings and keep certain price points for our customer base.”

    Despite price increases, Vigilante said he’s optimistic that there are still ways “folks can continue to enjoy great specialty coffee (that) works for their wallet.”

    Chris Vigilante in front of one of his coffee shops in College Park, Maryland, in September 2021.
    A man passes by Qualia Coffee on April 2, 2023, in Washington, DC.

    The 50% tariff on top US exporter Brazil, which has seen its coffee bean supply shrink due to a drought, weighs the heaviest on businesses.

    Doug Ilg, the owner of Celtic Cup Coffee Roasting in Silver Spring, Maryland, has avoided Brazilian coffee because of the huge tariffs. He doesn’t import coffee himself but buys primarily from third parties and has noticed costs rise in the last eight months.

    Trump’s tariffs “definitely changed things,” Ilg said.

    For instance, customers now may pay roughly 63 cents more per pound of beans compared to January because of the additional cost of tariffs this year, he said.

    The additional costs also put more pressure on small and medium-sized businesses that invest more upfront, said McLaughlin of the Conference Board.

    Joel Finkelstein, the owner of Qualia Coffee, which sells at farmers’ markets around DC, said it’s “really hard” to anticipate where his business will be in a year or two because of factors such as uncertainty about pricing.

    “Every small business, unless you’re in a very fortunate position, is constantly assessing whether it makes sense to stay open,” Finkelstein said.

    Continue Reading

  • A Service Evaluation of Antenatal Detection of Small-for-Gestational-Age Infants in a UK National Health Service Trust

    A Service Evaluation of Antenatal Detection of Small-for-Gestational-Age Infants in a UK National Health Service Trust


    Continue Reading

  • Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study

    – Late-Breaking ASCENT-03 Data Simultaneously Presented at ESMO 2025 and Published in The New England Journal of Medicine –

    – With Two Positive Phase 3 Trials, Trodelvy Has Potential as the First and Only ADC to be a Backbone Standard of Care for All First-Line Metastatic TNBC Patients Regardless of PD-L1 Status –


    Gilead Sciences, Inc. (Nasdaq: GILD) today shared positive data from the Phase 3 ASCENT-03 study demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Trodelvy® (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors. These findings will be presented today during a late-breaking oral session at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract #LBA20) and simultaneously published in The New England Journal of Medicine.

    ASCENT-03 successfully met its primary endpoint of PFS with a 38% reduced risk of disease progression or death for Trodelvy versus chemotherapy (HR: 0.62; p<0.0001). Median PFS with Trodelvy was 9.7 months versus 6.9 months for chemotherapy. The PFS results for Trodelvy versus chemotherapy were consistent across prespecified subgroups, including among patients with poorer prognosis (such as those whose cancer recurred less than one year after treatment in the curative setting) and regardless of chemotherapy chosen.

    “Patients with metastatic TNBC who are ineligible for immunotherapy face an especially poor prognosis, with limited treatment options and fast disease progression,” said Dr. Javier Cortés, Head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study. “The ability of sacituzumab govitecan to significantly delay death and progression could represent the first major treatment advance for this patient population in the 20 years since TNBC was defined, marking an historic shift and establishing a potential new standard of care.”

    The objective response rate (ORR) was 48% with Trodelvy and 46% with chemotherapy. Median duration of response (DOR) was substantially longer with Trodelvy. Among patients with confirmed complete or partial responses, DOR for Trodelvy was 12.2 months compared to 7.2 months with chemotherapy.

    Overall survival (OS) data were not mature at the time of PFS primary analysis. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.

    These results complement the recent presentation of ASCENT-04/KEYNOTE-D19, which showed a significant PFS benefit for Trodelvy plus Keytruda® (pembrolizumab) in PD-L1+ first-line metastatic TNBC. Gilead is engaging with the U.S. Food and Drug Administration and other global regulators regarding both data sets.

    “ASCENT-03 is the second Phase 3 trial with a Trodelvy-based regimen to show superior progression-free survival over chemotherapy in first-line metastatic TNBC, highlighting its potential to improve outcomes for patients with limited treatment options,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “With these potentially practice-changing results, Trodelvy is poised to transform the first-line metastatic TNBC treatment landscape, offering a much-needed alternative to chemotherapy.”

    Summary of Key ASCENT-03 Results

    Efficacy: Intent-to-Treat Population

    Trodelvy (n=279)

    Chemotherapy (n=279)

    Median PFS

    9.7 months (95% CI: 8.1-11.1)

    6.9 months (95% CI: 5.6-8.2)

    PFS hazard ratio and p-value

    0.62 (95% CI: 0.50-0.77); p<0.0001

    ORR

    48% (95% CI: 42-54)

    46% (95% CI: 40-52)

    DOR

    12.2 months (95% CI: 9.7-13.8)

    7.2 months (95% CI: 5.7-8.4)

    The safety profile of Trodelvy in the ASCENT-03 study was consistent with prior studies, and no new safety signals were identified in this patient population. The most frequent grade ≥3 treatment-emergent adverse events were neutropenia (43%) and diarrhea (9%) with Trodelvy and neutropenia (41%) and anemia (16%) with chemotherapy. Fewer patients discontinued treatment due to adverse events on Trodelvy than with chemotherapy (4% vs. 12%).

    Healthcare professionals have well-established experience with Trodelvy, with more than 60,000 breast cancer patients treated across 50+ countries over the past five years. It remains the only Trop-2-directed antibody-drug conjugate (ADC) to demonstrate meaningful survival benefits in both 2L+ metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2- mBC (IHC 0, IHC 1+, or IHC 2+/ISH–).

    The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

    About Triple-Negative Breast Cancer (In Patients Who Are Not Candidates for PD-1/PD-L1 inhibitors)

    Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionately impacts younger, pre-menopausal as well as Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

    Chemotherapy remains the mainstay of treatment in first-line metastatic TNBC patients who are not candidates for PD-1/PD-L1 inhibitors, and the need to improve outcomes continues to be high as there has not been a clinically meaningful advance for this patient population in over 20 years. In metastatic TNBC overall, ~50% of patients do not receive treatment beyond the first-line setting, demonstrating a need for additional effective earlier-line treatment options.

    About the ASCENT-03 Study

    The ASCENT-03 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy compared with treatment of physician’s choice in patients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer whose tumors do not express PD-L1, or who are PD-L1 positive and previously treated with a PD-(L)1 inhibitor in the curative setting. 558 patients were enrolled across multiple study sites worldwide.

    Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Treatment continued until blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Patients randomized to chemotherapy were eligible to cross over to Trodelvy upon disease progression.

    The primary endpoint of the study is progression-free survival (PFS) as assessed by BICR according to RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety.

    More information about ASCENT-03 is available at ClinicalTrials.gov: NCT05382299.

    About Trodelvy

    Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

    Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

    Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

    INDICATIONS

    TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

    • Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
    • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: NEUTROPENIA AND DIARRHEA

    • TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
    • TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.

    CONTRAINDICATIONS

    • Severe hypersensitivity reaction to TRODELVY.

    WARNINGS AND PRECAUTIONS

    Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

    Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

    Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

    Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

    Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

    Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

    ADVERSE REACTIONS

    In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

    In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

    In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

    DRUG INTERACTIONS

    UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

    UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

    Please see full Prescribing Information, including BOXED WARNING.

    About Gilead and Kite Oncology

    Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy (such as ASCENT-03); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

    Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

    U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.

    For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).


    Source: Gilead Sciences, Inc.

    Continue Reading

  • ESMO: Tubulis’ next-gen ADC posts 59% response rate, justifying investor interest – Fierce Biotech

    1. ESMO: Tubulis’ next-gen ADC posts 59% response rate, justifying investor interest  Fierce Biotech
    2. German biotech firm Tubulis raises $358 million to develop targeted cancer treatments  MSN
    3. Tubulis lands record 308 million euro funding to advance ADC pipeline  The Pharma Letter
    4. Wellington Management Joins $361M Series C for Cancer Drug Developer Tubulis  citybiz
    5. Research transfer: LMU spin-off Tubulis secures financing for cancer research  LMU München

    Continue Reading

  • FLAURA2 Trial: Osimertinib Plus Chemotherapy Improves Overall Survival Across Prognostic Subgroups in EGFR-Mutated Advanced NSCLC — Presented at ESMO 2025

    FLAURA2 Trial: Osimertinib Plus Chemotherapy Improves Overall Survival Across Prognostic Subgroups in EGFR-Mutated Advanced NSCLC — Presented at ESMO 2025

    The Phase 3 FLAURA2 trial (NCT04035486) continues to strengthen the role of combination therapy in the first-line management of EGFR-mutated (EGFRm) advanced non–small cell lung cancer (NSCLC). At ESMO 2025, investigators reported the final overall survival (OS) analysis, showing that osimertinib (osi) plus platinum–pemetrexed chemotherapy (CTx) achieved a statistically significant and clinically meaningful OS improvement compared with osimertinib monotherapy.

    This milestone confirms the combination as a first-line standard of care in EGFRm NSCLC, offering durable efficacy across key subgroups, including those with traditionally poor prognostic features such as CNS metastases, L858R mutations, plasma-detectable EGFRm, and altered TP53.

    Methods

    The FLAURA2 trial enrolled 557 patients with EGFRm advanced NSCLC, who were randomized 1:1 to receive osimertinib plus chemotherapy (n=279) or osimertinib alone (n=278). The chemotherapy regimen consisted of platinum–pemetrexed, administered concurrently with osimertinib.

    Baseline CNS imaging (CT or MRI) was mandatory to identify central nervous system metastases. EGFR mutation subtypes (Ex19del or L858R) were confirmed through central or locally approved assays. Plasma EGFR mutation detection was evaluated via droplet digital PCR (Biodesix), while TP53 mutation status was determined using FoundationOne CDx.

    OS outcomes were analyzed using an unstratified Cox proportional hazards model, with subgroup analyses conducted based on baseline prognostic factors.

    Results

    A total of 557 patients were included: 279 in the osimertinib + CTx arm and 278 in the osimertinib monotherapy arm. The overall hazard ratio (HR) for OS was 0.77 (95% CI 0.61–0.96; p=0.02), corresponding to a 23% reduction in risk of death with the combination regimen.

    CNS Metastases

    In patients with baseline CNS metastases, median OS reached 40.9 months (95% CI 35.2–46.6) with osimertinib + CTx versus 29.7 months (95% CI 25.6–35.8) with monotherapy (HR 0.72; 95% CI 0.52–0.99).

    EGFR Mutation Subtype

    Both EGFRm subgroups derived benefit.

    • L858R: median OS 38.1 vs 32.4 months (HR 0.76; 95% CI 0.55–1.07)
    • Ex19del: median OS not reached (NR) vs 43.0 months (HR 0.76; 95% CI 0.56–1.02)

    Plasma EGFR Mutation Detection

    Patients with detectable plasma EGFRm achieved median OS 38.4 vs 32.5 months (HR 0.79; 95% CI 0.60–1.03), while those with undetectable mutations had not reached median OS in either arm.

    TP53 Alteration Status

    Among patients with altered TP53, OS improved to 51.1 months vs 43.1 months (HR 0.71; 95% CI 0.40–1.27), showing consistent benefit across molecular profiles.

    No new safety signals were reported, confirming that the addition of chemotherapy did not compromise the established tolerability of osimertinib.

    flaura2-trial

    Interpretation

    The survival improvement observed with osimertinib plus chemotherapy extended across every prognostic subgroup examined. The HRs for OS within each category closely mirrored those of the overall intent-to-treat (ITT) population, highlighting the robustness and reproducibility of the benefit.

    Particularly noteworthy were the gains among patients with CNS metastases and L858R mutation, two subsets traditionally associated with poorer prognosis. These data underline the capacity of the combination regimen to overcome key resistance mechanisms and delay disease progression.

    flaura2-trial

    Long-Term Follow-Up and Analytical Considerations

    The long-term follow-up from the FLAURA2 trial at ESMO 2025 provides the most comprehensive survival dataset to date for EGFR-mutated NSCLC treated with first-line osimertinib plus chemotherapy. With several subgroups not yet reaching median OS, the sustained separation of survival curves indicates a persistent and cumulative treatment effect extending well beyond the chemotherapy phase.

    Investigators emphasized that the survival curves for osimertinib + CTx began to diverge early—within the first year of treatment—and remained separated throughout follow-up, suggesting that early dual blockade of EGFR signaling and microenvironmental suppression via chemotherapy offers durable control of micrometastatic disease.

    The analysis also highlights that median OS was not reached in multiple subgroups, demonstrating an ongoing trend toward improved long-term outcomes. The consistency of benefit across genomic and clinical subgroups—including those with TP53 alterations or detectable circulating tumor DNA—supports the biological rationale that concurrent chemotherapy may help prevent the emergence of resistant clones.

    Methodologically, the trial’s unstratified Cox model ensured unbiased subgroup comparisons and confirmed that the treatment effect was independent of baseline risk characteristics. Furthermore, despite crossover and subsequent therapies available post-progression, the OS advantage with osimertinib plus chemotherapy persisted, reinforcing the value of front-line combination therapy over sequential monotherapy strategies.

    No late-emerging toxicities or cumulative safety concerns were identified during long-term follow-up, strengthening the safety profile of the regimen. Together, these findings establish osimertinib plus chemotherapy as a durable, well-tolerated, and biologically rational first-line standard of care for patients with EGFR-mutated advanced NSCLC.

     

    Read Full Abstract on ESMO Congress 2025 Website 

    You Can Watch More on OncoDaily Youtube TV

    Written by Armen Gevorgyan, MD

    Continue Reading