Category: 3. Business

  • NASA Rehearses How to Measure X-59’s Noise Levels

    NASA Rehearses How to Measure X-59’s Noise Levels

    In a stretch of California’s Mojave Desert, NASA conducted a full-scale “dress rehearsal” to prepare how it will measure the noise generated by the X-59 quiet supersonic research aircraft.

    The team behind the successful test flight series operates under NASA’s Commercial Supersonic Technology project. Beginning June 3 and concluding this week, researchers conducted a dry run for Phase 2 of NASA’s Quesst mission, when it will capture audio of the sonic thumps the X-59 will produce, rather than loud sonic booms associated with supersonic flight.

    “The dress rehearsal was critical for us,” said Larry Cliatt, sub-project manager for the Quesst acoustic validation phase, who is based at NASA’s Armstrong Flight Research Center in Edwards, California. “It gave us the opportunity to run through every aspect of our operation, from flight planning to data collection. In between those activities, we practiced aircraft operations, setting up the Ground Recording Systems, meteorological data collecting, and refining control room procedures. We were able to fine-tune our timelines, improve communication across teams, and ensure that when we perform these test with the X-59 aircraft, everything will run smoothly.”

    During the tests, at NASA Armstrong, an F-15B aircraft served as a stand-in for the X-59, flying faster than the speed of sound and making multiple passes over the Mojave sands. While it flew, researchers captured acoustic data using a linear array of ground recording systems spaced across miles of open desert, recorded weather readings, and measured the shock waves it generated.

    For a supersonic aircraft like the F-15B, shock waves typically result in loud sonic booms, but the X-59 is designed to diffuse them in a way that will dramatically limit noise.

    NASA’s Quesst mission aims to enable quiet supersonic flight over land using data from the X-59. The experimental aircraft will begin making its first flights this year – the first phase of Quesst.

    But even before it takes to the air, the mission began its preparations for Phase 2 with the dry run, which focused on practicing under realistic test conditions and identifying issues before the official campaign begins, not collecting data from the F-15B.

    Through Quesst’s development of the X-59, NASA will deliver design tools and technology for quiet supersonic airliners that will achieve the high speeds desired by commercial operators without disturbing people on the ground. NASA will also validate design tools through ground and flight testing, providing aircraft manufacturers the ability to explore new quiet supersonic concepts and have confidence that their resulting designs will meet requirements for quiet flight.

    Most importantly, Quesst will gather data to understand community response to sounds generated during flight – key knowledge for a quiet supersonic future.

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  • Opportunities, Pitfalls, and Regulatory Developments in Asia – Publications

    Opportunities, Pitfalls, and Regulatory Developments in Asia – Publications


    Insight




    July 25, 2025

    Artificial intelligence has become one of the most transformative forces in modern finance, reshaping how investment firms operate, analyze data, and interact with clients. AI is no longer a futuristic concept but rather a practical tool driving efficiency, innovation, and competitive advantage. However, its rapid adoption also brings potential risks and regulatory challenges, particularly in Asia where markets are embracing AI at different speeds.

    This Insight explores the current state of AI in investment management in Asia, its key applications, emerging threats, and the evolving regulatory landscape. 

    THE GROWING IMPORTANCE OF AI IN FINANCE

    AI has cemented its role as a game-changer, with investment firms increasingly integrating such systems into their operations. Unlike previous technological shifts, AI development is happening at an unprecedented pace, becoming both more advanced and more affordable. At its core, AI encompasses machine learning, whereby systems improve decision-making by analysing vast datasets, and natural language processing, which allows computers to interpret and generate human language. Generative AI, capable of creating humanlike text, images, and financial forecasts, has been particularly disruptive. 

    2024 marked a turning point as businesses progressed past experimentation, implementing AI in real-world scenarios. In 2025 and beyond, AI is expected to become even more deeply embedded in financial services, with governance frameworks solidifying alongside technological advancements. Against the backdrop of the EU AI Act, the world’s first AI-focused legislation, setting a global precedent, Asia’s regulatory approach remains fragmented, creating both opportunities and challenges for firms operating in the region. 

    KEY APPLICATIONS OF AI IN INVESTMENT MANAGEMENT

    Investment managers have been among the early adopters of AI, leveraging its capabilities across several critical functions. In portfolio management, AI algorithms analyze market trends, risk factors, and economic indicators to optimize asset allocation. Trading strategies have also benefited, with AI enhancing pre-trade analysis, execution speed, and post-trade evaluations. Risk management has seen significant improvements as AI models process both quantitative data and qualitative sources (such as news articles) to predict market movements and assess counterparty risks. 

    Another major application is robo-advisory services, where AI-driven platforms provide automated, data-backed financial advice to retail investors. These tools offer personalized recommendations at scale, reducing costs and improving accessibility. Beyond these core uses AI is also being applied to compliance monitoring, fraud detection, and client relationship management, demonstrating its versatility across the investment lifecycle. 

    EMERGING RISKS

    While AI offers immense benefits, it also introduces new risks that firms must address. AI-inspired threats include reverse engineering, where cybercriminals infiltrate datasets to steal proprietary algorithms or trading strategies. Data poisoning, another growing concern, involves manipulating training data to skew AI outputs, potentially leading to flawed investment decisions. Synthetic identity fraud, facilitated by AI-generated fake personas, is also on the rise, complicating security and due diligence processes. 

    Perhaps more alarming are AI-enabled threats, such as deepfake scams. A notable case in Hong Kong saw fraudsters use AI-generated video calls to impersonate executives, deceiving employees into authorizing fraudulent transactions. AI-powered social engineering attacks, including highly convincing phishing emails and voice clones, further amplify cybersecurity risks. These threats underscore the need for robust governance frameworks, employee training, and advanced detection tools to mitigate vulnerabilities. 

    REGULATORY DEVELOPMENTS IN ASIA AND BEYOND

    Regulators worldwide are racing to keep pace with AI’s rapid evolution. The EU AI Act is likely to influence global standards much like the EU General Data Protection Regulation (GDPR) did for global data protection laws. In Asia, regulatory approaches vary widely. China has taken interim measures on generative AI, focusing on systems that threaten national security or socialist values. A broader AI law is expected soon. 

    India is also considering AI-focused legislation, while jurisdictions such as Singapore and Hong Kong have opted for their own guidelines, prioritizing innovation. This patchwork of rules can create compliance challenges for firms operating across multiple markets, requiring careful navigation to avoid legal pitfalls. 

    MANAGING THIRD-PARTY AI RISKS

    As investment firms increasingly rely on external AI providers, managing third-party risk has become crucial. Many vendors request access to sensitive data during initial testing phases, raising concerns about intellectual property protection and competitive exposure. Contracts must clearly define data ownership, usage rights, and liability for AI errors such as biased or inaccurate outputs. Compliance remains a moving target, as AI providers often resist strict legal assurances in an uncertain regulatory environment. 

    Firms must also scrutinize vendors’ cybersecurity measures and ethical AI practices to ensure alignment with their own risk tolerance. Establishing clear governance structures and conducting regular audits can help mitigate potential issues before they escalate. 

    INVESTMENT RISKS IN AI STARTUPS

    For investors backing AI-driven startups, due diligence is more critical than ever. Beyond traditional financial assessments, investors must evaluate regulatory exposure, particularly in more heavily regulated jurisdictions. The quality and sources of training data, potential biases in AI models, and cybersecurity resilience all require thorough examination. 

    Fund-level protections, such as provisions for regulatory divestment, are becoming essential in limited partnership agreements to safeguard against unforeseen legal changes. Investors should also monitor geopolitical developments, as national security reviews (e.g., CFIUS in the United States) increasingly scrutinize AI-related transactions. 

    CONCLUSION

    AI is transforming investment management, offering unprecedented opportunities for efficiency, innovation, and growth. However, its risks—from deepfake fraud to regulatory complexity—require a proactive and strategic approach. Firms must balance technological adoption with robust governance and ensure AI is deployed responsibly and securely. 

    As regulations evolve and AI capabilities expand, staying informed and adaptable will be key to success: those who are proactive in navigating the challenges of this current AI revolution will likely be best positioned to thrive in the dynamic landscape of modern finance.

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  • Exclusive: China's Sciwind is in talks to license weight-loss drug in US, CEO says – Reuters

    1. Exclusive: China’s Sciwind is in talks to license weight-loss drug in US, CEO says  Reuters
    2. Hengrui Pharma targets obesity drug launch after test success  thebambooworks.com
    3. Navigating the GLP-1 Opportunity In China: Strategic Imperatives For Western Pharma  insights.citeline.com
    4. China’s Sciwind is in talks to license weight-loss drug in US, CEO says  PharmaLive

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  • Nationwide boss’s £7m pay package declared ‘obscenity’ during AGM | Nationwide

    Nationwide boss’s £7m pay package declared ‘obscenity’ during AGM | Nationwide

    A £7m pay package for the Nationwide chief executive, Debbie Crosbie, has been labelled an “obscenity” and hypocritical by members of the mutual, even as it gained approval at the building society’s AGM on Friday.

    Concerned members who tuned into the online-only meeting on Friday morning criticised the board’s plan to increase Crosbie’s maximum payout by 43%, saying the move was out of touch and did not align with the mutual’s principles.

    One member, identified as Ms Andrews, said: “No one needs to earn more than £1m in salary, and certainly not £7m.” Another member, Mr Fisher, asked :“Does the CEO see both the irony and the hypocrisy of the size of her bonus: an amount in one year that most people would struggle to spend in a lifetime?”

    Meanwhile, a member identified as Dr Standon said that Nationwide already had the option of paying Crosbie up to £4.8m, and that pushing that figure to £7m was “an obscenity”.

    “One would expect Nationwide to set an example to others,” she said.

    Nationwide argued that Crosbie’s pay rises reflected new demands after its £2.9bn takeover of Virgin Money, and its remuneration should be close to packages offered by rivals including Lloyds Banking Group and NatWest.

    “We pay more than most building societies, but then again, we are larger,” the head of Nationwide’s remuneration committee, Tracey Graham, said. “We are five times larger than Coventry, we are more complex, and we are more important to the UK economy than other building societies … We are now the second largest mortgage lender and savings provider in the UK, and yet we pay less than compared to the high street banks.

    “Our job is to ensure that we have the very best leaders here at Nationwide, and we do operate in a competitive marketplace. That is what we need to pay them, for us to believe that we are paying them equally or fairly.”

    Standon acknowledged that Nationwide had done “lots of good things for members … and it’s commendable that you followed through on the principles behind mutuality by not prioritising profit”. But she said that while the building society claimed to value people over profits, its justification for the rise “suggests that unfortunately, your executive team are primarily motivated by money”.

    “If they do leave purely because of the money, then, is it not the case that they were not in line with Nationwide principles in the first place?” Standon asked.

    The Nationwide chair, Kevin Parry, defended the building society’s bosses, saying: “I don’t think that money is the primary motivation … I’m very confident in saying this is not about personal greed. This is about equity with people that do similar jobs elsewhere.”

    Members ultimately gave the green light to the pay policy: 627,982, or 94.8%, voted in favour. Nationwide said 34,492 members, accounting for 5.2% of voters, rejected the pay package.

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    Nationwide’s board was criticised by one member over the fact that members were not given a binding votes. Parry, confirmed that while votes to re-elect board members are binding – meaning members have a final say – Nationwide is not required to hold binding votes on pay under building society rules.

    The board was also forced to admit during the livestreamed AGM that a £316m accounting error was missed by the building society and its auditor EY, and only came to light as a result of one of its eagle-eyed members, Mr Dugan.

    Nationwide explained that while it did force the building society to correct its 2024 results, the mistake related to the way it had deducted expenses from its income, but did not affect profitability.

    Dugan pushed the matter, saying the error was six times larger than the £55m threshold at which errors are deemed material, meaning the point at which they could end up influencing business decisions. He asked why Nationwide was willing to reappoint EY on that basis.

    “We were very grateful last year when you identified the issue,” the chair of Nationwide’s audit committee, Phil Rivett, said during the AGM. However, he said the society was still “very satisfied with the quality of the work they [EY] do, and the challenge that they provide to management on accounting judgments and issues”.

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  • The Quest to Boost Operational Efficiency and Returns in DC Master Trusts

    The Quest to Boost Operational Efficiency and Returns in DC Master Trusts

    History

    Defined Contribution (DC) Master Trusts have become a cornerstone of the UK pension landscape, offering a cost-effective alternative to single-employer trusts and an efficient way to manage retirement savings for multiple employers and their employees.

    Though they emerged as a niche product in the 1970s, DC Master Trusts only started to garner broader adoption in the UK workplace pension market following the 2012 advent of automatic enrolment.1 As of 2023, Master Trusts are the DC vehicle of choice at 28% of FTSE 350 companies, up from just 6% in 2014.2

    Scale

    The DC Master Trust share of the workplace pensions market could expand to £400 bn by 2026, up five-fold from £80 bn in 2021, per Hymans Robertson LLP.3 That could reach £800 bn by decade’s end, according to chancellor of the exchequer Rachel Reeves.4

    This increased scale could bolster the sophistication these schemes have in their investment strategies, according to analysis from the Department for Work and Pensions (DWP).5 That means these schemes could allocate a greater proportion of their capital to private markets and also incorporate model portfolios that target a particular balance of return and risk.

    Consolidation

    At the same time, while balances in DC Master Trusts have ballooned and their underlying investments have grown increasingly illiquid, the total number of Master Trusts plummeted from 90 to 37 following the 2018-2019 introduction of a requirement for Master Trusts to meet stringent criteria when applying to The Pensions Regulator (TPR) for authorization.6 As of Dec. 31, 2024, the total number of UK DC Master Trusts stands at 33.7

    The robust assets under management (AUM) momentum DC Master Trusts are experiencing across far fewer schemes that are themselves invested in more unlisted assets means the administration of these trusts presents significant challenges, particularly in the areas of cash allocation and portfolio rebalancing, along with data management and client reporting. It may prove beneficial to utilize a “Cash Allocation and Rebalancing Application” (CARA), a solution that has seen success in Australia, in addition to an outsourced data management solution to enhance operational efficiency, streamline liquidity management and asset allocation changes, and attempt to improve investment outcomes for members. Get access to the full whitepaper by clicking “Download Report”. 

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  • Stock Market Today: Dow and Dollar Rise; One Week Until Tariff Deadline — Live Updates – The Wall Street Journal

    1. Stock Market Today: Dow and Dollar Rise; One Week Until Tariff Deadline — Live Updates  The Wall Street Journal
    2. US stocks set more records as Verizon begins a big week for profit reports with a beat  AP News
    3. Dow Futures surge 70 points today: 5 things to know before Wall Street opens  Invezz
    4. Week Ahead – July 28th  TradingView
    5. Traders Await Fresh Cues After Record Closes for Major Benchmarks, Driving Muted Premarket Action for US Equity Futures  MarketScreener

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  • Renewable Energy Directive – Commission guidance on battery-related data sharing

    Renewable Energy Directive – Commission guidance on battery-related data sharing

    A Commission notice on battery-related data sharing (C/2025/4907) under the revised Renewable Energy Directive has been published today aimed at helping EU countries implement Article 20a, paragraph 3 of the directive. Aimed at giving more transparency and supporting the energy transition – these provisions relate to real-time, cost-free sharing of electric vehicle battery data with users and authorised third parties, covering elements such as the state of charge, health of the battery and location. The aim of this document is to make it easier for EU countries to adopt a uniform approach to the requirements. 

    The overall aim of the data sharing obligations is to improve transparency. In turn, this will support functionalities such as smart and bidirectional charging, and enable better integration of these batteries with energy systems. It entails making data accessible via Over-the-Air through existing points, or when plugged into recharging points, using cables or WIFI. 

    Once in place, the system should enable and facilitate new, useful services for electric vehicle owners or users — like apps that offer smarter driving— thanks to access to real time battery data for free. Ultimately this will lead to notable benefits for consumers such as simpler road planning, optimised charging and improved battery performance monitoring. 

    This notice follows a series of recommendations and guidance notes on different elements of the Renewable Energy Directive published by the Commission in September 2024 and July 2025.

    Related links 

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  • Stockton MP criticises approval of Byers Gill solar farm

    Stockton MP criticises approval of Byers Gill solar farm

    Bill Edgar

    Local Democracy Reporting Service

    RWE  A big, flat grassy field with a tree on the horizon .RWE

    Byers Gill solar farm will have a lifespan of 40 years, after which it will be removed

    An MP says he is “disappointed and angry” over a government decision to approve a large, £200m solar farm.

    Conservative Matt Vickers, who represents Stockton West, has warned the Byers Gill Solar Farm near Darlington and Stockton will harm the local landscape.

    “It will damage our rich tapestry of wildlife and biodiversity and could have a huge impact on our village communities and food security,” Vickers said.

    The government said it would reduce bills and provide energy security, while developer RWE said the facility would be removed at the end of its estimated 40-year lifespan.

    Vickers previously spoke against the solar farm during a House of Commons debate in 2024, as large swathes of nearby greenbelt land have been obtained by developers for solar farms.

    According to the Local Democracy Reporting Service, the 180MW farm would be made up of several blocks of development located in Brafferton, Hauxley Farm, Byers Gill Wood, Great Stainton and two near Bishopton.

    RWE said the development will cover about 490 hectares (1,211 acres) of land in total.

    A mainly white map showing roads and the boundaries of fields, with areas in green to show where solar panels will be built.

    Byers Gill Solar Farm is made up of several blocks of development

    Speaking after the government’s decision to approved the plans, Vickers said: “Labour is so obsessed with net-zero and solar farms that they’re happy to bulldoze through the views of local residents to push ahead with it.”

    He claimed Labour “couldn’t give a damn about the views of local people”.

    But the energy consumers minister Miatta Fahnbulleh said: “Families in the North East have seen their energy bills go through the roof as a result of our exposure to volatile gas prices.

    “The only way to make British people better off in the long term is by securing clean, homegrown power that we control.”

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  • Isatuximab Plus VRd Approved in Europe for Transplant-Eligible Newly Diagnosed Multiple Myeloma

    Isatuximab Plus VRd Approved in Europe for Transplant-Eligible Newly Diagnosed Multiple Myeloma

    Multiple Myeloma | Image
    Credit: © LASZLO –
    stock.adobe.com

    The European Commission (EC) has granted approval to isatuximab-irfc (Sarclisa) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Isa-VRd) as induction therapy for adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1

    This decision follows the positive opinion granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June, 2025.

    Results from part 1 of the phase 3 German-speaking Myeloma Multicenter Group (GMG)-HD7 study (NCT03617731) supported the European Union (EU) approval. In this trial, Isa-VRd met the primary end point of part 1, improved minimal residual disease (MRD)–negativity rates at the end of the 18-week induction period, in transplant-eligible patients with newly diagnosed multiple myeloma.

    The data, which were published in the Journal of Clinical Oncology, also showed a complete response (CR) rate of 43.5% with Isa-VRd (n = 331) vs 34.0% for VRd alone (n = 329; OR, 1.49; 95% CI, 1.08-2.07; P = .013).2 Following ASCT, the MRD-negativity rates were 66.2% and 47.7%, respectively (OR, 2.13; 95% CI, 1.56-2.92; P < .0001).

    Both CR and MRD-negative status were achieved by 38.1% of patients in the Isa-VRd arm and 25.8% in the VRd arm (OR, 1.76; 95% CI, 1.25-2.50; P = .001). Preplanned exploratory analyses showed consistent MRD-benefit across most subgroups, excepting patients with a World Health Organization (WHO) performance status greater than 1, revised International Staging System stage III disease, or high-risk cytogenetics.

    “We have been on a mission to accelerate [isatuximab]’s clinical development program with the hope to bring this important medicine to as many people as possible living with multiple myeloma,” Olivier Nataf, Global Head of Oncology at Sanofi, stated in a news release.1 “Today’s decision represents a prime example of those efforts, and most importantly, paves the way for [isatuximab] to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”

    With this regulatory approval, isatuximab now holds 4 approved indications globally and is approved across all lines of therapy in the European Union, regardless of transplant eligibility, according to Sanofi.

    GMMG-HD7 Trial Overview

    GMMG-HD7 is a pivotal, randomized, open-label, multicenter, two-part trial designed to independently assess the effects of Isa-VRd during the induction and maintenance phases, followed by post-transplant re-randomization to isatuximab plus lenalidomide in transplant-eligible, newly diagnosed multiple myeloma.1

    A total of 662 patients were enrolled onto the trial across 67 sites in Germany. Eligible patients were between 18 to 70 years of age with a confirmed diagnosis of untreated multiple myeloma requiring systemic therapy, were candidates for high-dose therapy ASCT, and had a WHO performance status of 0 to 2.3

    In part one of the trial, patients were randomly assigned to receive 3, 42-day cycles of induction therapy with VRd with or without isatuximab. In the investigational arm, isatuximab was administered intravenously at 10 mg/kg on days 1, 8, 15, 22, and 29 of cycle 1, and on days 1, 15, and 29 of cycles 2 and 3.1,3 All patients then proceeded to intensification per GMMG standard, including stem cell mobilization and ASCT. After intensification, patients were randomized a second time to receive maintenance therapy with either lenalidomide alone or in combination with isatuximab for up to 3 years.

    The study’s co-primary end points are MRD negativity following induction, assessed via next-generation flow cytometry at a sensitivity threshold of 10⁻⁵, and progression-free survival (PFS) following the second randomization. Secondary end points include CR rate, overall survival (OS), PFS from the first randomization, and safety.

    Additional Efficacy and Safety Data

    MRD findings in part 1 of the GMMG-HD7 study were supported by the final PFS analysis.2 The median PFS was not reached in either arm, but a statistically significant improvement favored the Isa-VRd arm vs VRd alone (HR, 0.7; 95% CI, 0.52-0.95; stratified log-rank P = .0184).

    Landmark analyses further demonstrated that MRD negativity was associated with significantly prolonged PFS from both the end of induction (HR, 0.38; 95% CI, 0.26-0.55; P < .001) and the end of transplant (HR, 0.42; 95% CI, 0.28-0.63; P < .001) compared with MRD positivity. Among MRD-negative patients, PFS from the end of induction was comparable between treatment arms (P = .72). However, in patients with MRD-positive disease, Isa-VRd significantly extended PFS vs VRd alone (HR, 0.64; 95% CI, 0.43-0.96; P = .03). PFS from the end of transplant did not significantly differ between treatment arms for either MRD-negative (P = .882) or MRD-positive (P = .314) subgroups.

    From the start of maintenance therapy, patients with continued MRD negativity had significantly prolonged PFS vs those without (HR, 0.41; 95% CI, 0.25-0.65; P < .001). Among patients with sustained MRD negativity, PFS did not differ by treatment arm (P= .77). In patients without sustained MRD negativity, there was a trend toward improved PFS with isatuximab plus VRd, though this did not reach statistical significance (HR, 0.68; 95% CI, 0.41-1.13; P = .14). OS data were not mature at the time of analysis (stratified log-rank v = .548).

    Regarding safety, Isa-VRd demonstrated a manageable and consistent safety profile, according to prior findings from an interim analysis of GMMG-HD7.

    Data from part 2 of the GMMG-HD7 study, which evaluates the maintenance phase, are pending.1 These findings contribute to the growing body of clinical evidence supporting the use of isatuximab in the frontline setting, Sanofi concluded in the news release.

    References

    1. Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma. News release. Sanofi. July 25, 2025. Accessed July 25, 2025.https://www.sanofi.com/en/media-room/press-releases/2025/2025-07-25-05-00-00-3121591
    2. Mai EK, Bertsch U, Pozek E, et al. Isatuximab, lenalidomide, bortezomib, and dexamethasone induction therapy for transplant-eligible newly diagnosed multiple myeloma: final part 1 analysis of the GMMG-HD7 trial. J Clin Oncol. 2025;43(11):1279-1288. doi:10.1200/JCO-24-02266
    3. Trial on the effect of isatuximab to lenalidomide, bortezomib/dexamethasone (RVd) induction and lenalidomide maintenance in patients with newly diagnosed myeloma (GMMG HD7). ClinicalTrials.gov. Updated January 24, 2025. Accessed Accessed July 25, 2025. https://www.clinicaltrials.gov/study/NCT03617731

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  • CHMP Recommends EU Approval of Vorasidenib for IDH1/2-Mutant Grade 2 Glioma

    CHMP Recommends EU Approval of Vorasidenib for IDH1/2-Mutant Grade 2 Glioma

    IDH1/2-Mutant Grade 2 Glioma |
    Image Credit: © alexlmx
    – stock.adobe.com

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of vorasidenib (Voranigo) for the treatment of predominantly non-enhancing grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older who have undergone surgical resection and are not in immediate need of radiotherapy or chemotherapy.1

    The CHMP recommendation is supported by findings from the phase 3 INDIGO trial (NCT04164901), a global, randomized, double-blind, placebo-controlled study evaluating vorasidenib in 331 patients with residual or recurrent grade 2 IDH-mutant glioma following surgery. 1,2

    Results published in The New England Journal of Medicine showed that vorasidenib significantly improved progression-free survival (PFS) compared with placebo, with a median PFS of 27.7 months vs 11.1 months, respectively (hazard ratio [HR], 0.39; 95% CI, 0.27-0.56; P < .001).2 Time to next intervention was also significantly delayed with vorasidenib (HR, 0.26; 95% CI, 0.15-0.43; P < .001).2

    Grade 3 or higher adverse effects occurred in 22.8% of patients receiving vorasidenib vs 13.5% in the placebo group. Elevated alanine aminotransferase levels of grade 3 or higher were reported in 9.6% of patients receiving vorasidenib and in none of the placebo-treated patients. No treatment-related deaths were reported.

    “Today’s recommendation for European Union [EU] approval brings us one step closer to offering [vorasidenib] to patients in the EU with grade 2 IDH-mutant glioma who have historically had limited treatment options for this relentless disease,” Susan Pandya, MD, vice president of Clinical Development and global head of oncology LS/LCM, at Servier, said in a news release.1

    The marketing authorization application for vorasidenib will now be reviewed by the European Commission. If approved, vorasidenib would represent the first targeted therapy option in the EU for patients with grade 2 IDH-mutant diffuse glioma.

    INDIGO Study Design

    In the phase 3, double-blind INDIGO trial, patients with residual or recurrent grade 2 IDH-mutant glioma who had undergone surgery as their only prior treatment were enrolled.2 As of March 7, 2023, 331 patients were randomized globally to receive vorasidenib 40 mg daily (n=168) or placebo (n=163) continuously in 28-day cycles. Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo).

    The study’s primary end point was PFS. A key secondary end point was the time to the next anticancer intervention. Other secondary end points were objective response rate, tumor growth rate by volume, overall survival, and safety.

    Crossover from placebo to vorasidenib was permitted upon confirmation of imaging-based disease progression. Safety outcomes were also evaluated throughout the study.

    Current Indications for Vorasidenib

    Currently, vorasidenib is the first and only approved therapy designed to target mutant IDH enzymes in grade 2 glioma.1

    This positive recommendation follows similar regulatory stances, including the August 6, 2024, FDA approval of vorasidenib for the treatment of IDH1/2-mutant grade 2 diffuse glioma following surgical resection. In addition to its approval in the United States, vorasidenib has also been granted marketing authorization in countries such as Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, and Switzerland.

    “We look forward to continuing conversations with the EMA and other regulatory bodies around the world to introduce [vorasidenib] as a potential new standard of care for patients with IDH-mutant gliomas,” Pandya concluded.

    References

    1. Servier receives positive CHMP opinion for VORANIGO® (vorasidenib) for the treatment of adults and adolescents with grade 2 IDH-mutant diffuse glioma. News Release. Pr Newswire. Accessed July 25, 2025. https://servier.com/en/newsroom/positive-opinion-chmp-voranigo-idh-mutant-glioma/
    2. Mellinghoff IK, Martin, Blumenthal DT, et al. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. The New England Journal of Medicine. 2023;389(7). doi:0.1056/nejmoa2304194

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