Category: 3. Business

  • Notable Threat Updates and Looking Ahead

    Notable Threat Updates and Looking Ahead

    We recently published an Insights piece “The Golden Scale: Bling Libra and the Evolving Extortion Economy,” which primarily focused on the Salesforce data theft extortion activity. This was associated with the cybercriminal syndicate known as Scattered LAPSUS$ Hunters. Since early October 2025, we have observed several notable developments within a Telegram channel (SLSH 6.0 part 3) used by the threat actors. This activity may provide a glimpse into how the group plans to operate in the foreseeable future. We’re providing these insights so that organizations can better prepare for and defend against this evolving threat activity.

    Fallout From the Extortion Deadline

    As noted in our previous Insights piece, Scattered LAPSUS$ Hunters listed the deadline for impacted organizations to make a ransom payment as 11:59 PM ET on Oct. 10, 2025. Since that time, news reports have indicated that the threat actors have leaked stolen data allegedly belonging to six companies. These companies operate across the aviation, energy and retail sectors. The leaked data allegedly includes various types of personally identifiable information (PII) such as names, dates of birth, email addresses, phone numbers and frequent flyer numbers.

    Unit 42 recently tried to access the data leak site (DLS) associated with the threat actors, and noticed the website had what appeared to be a defacement message posted (see Figure 1). As a result, we were unable to determine if any victim data was still listed.

    Figure 1. Screenshot of message posted to Bling Libra’s latest DLS as of Oct. 17, 2025. Source: Scattered LAPSUS$ Hunters’ DLS.

    On Oct. 11, 2025, a day after the posted deadline and the release of data for the six organizations referenced above, the threat actors stated that “nothing else will be leaked.” The meaning of “the things we have cannot be leaked for obvious reasons” is unclear (see Figure 2). These “obvious reasons” could mean increased attention and action from law enforcement due to who owns the data or its type.

    Telegram screenshot reads: "A lot of people are asking what else will be leaked. Nothing else will be leaked. Everything that was leaked was leaked, we have nothing else to leak and obviously the things we have cannot be leaked for obvious reasons. :D
    Figure 2. Screenshot of Telegram post to SLSH 6.0 part 3 channel on Oct. 11, 2025. Source: Telegram.

    As shown below in Figure 3, the threat actors appear to potentially be stepping away from any activities until the beginning of next year. A post after this one states “I promise you, you WILL feel our wrath.”

    Telegram screenshot with a statement from the threat actors on their continuous operations targeting global corporations and critical infrastructure, and insisting they are not criminals but businessmen.
    Figure 3. Screenshot of Telegram post to SLSH 6.0 part 3 channel on Oct. 11, 2025. Source: Telegram.

    Extortion-as-a-Service Program Advertisement

    On Oct. 10, 2025, shortly prior to their self-imposed deadline, the threat actors formally alluded to the launch of their extortion-as-a-service (EaaS) program as shown in Figure 4. They claim this EaaS program will be similar to a typical ransomware-as-a-service (RaaS) program with a clear difference: no file encryption. As noted in my previous Insights piece, one likely factor for this shift is to potentially fly under the radar of law enforcement attention. This could be motivated by their focus on disrupting ransomware operations in recent years.

    Telegram screenshot announcing the launch of a new EaaS (Extortion-as-a-Service), detailing features such as anonymity and professional negotiation support, with further details to be released soon.
    Figure 4. Screenshot of Telegram post to SLSH 6.0 part 3 channel on Oct. 10, 2025. Source: Telegram.

    Renewed Insider Access Recruitment

    On Oct. 5, 2025, the threat actors posted an advertisement seeking insider access at organizations across a variety of industries, as seen in Figure 5.

    As also noted by ReliaQuest on their X account, the threat actors state their primary interest is in acquiring access to call centers, gaming companies, hosting providers, software-as-a-service (SaaS) and telecom organizations. These organizations would be based in countries such as the U.S., UK, Australia, Canada and France.

    Telegram screenshot that includes information on rules, IA rates, employee or insider recruitment, and regions of focus.
    Figure 5. Screenshot of Telegram post to SLSH 6.0 part 3 channel on Oct. 5, 2025 Source: Telegram.

    Threat actors affiliated with “The Com” have previously advertised interest in partnering with insiders at targets of interest to them. This was reported in our May 2025 update on Muddled Libra (aka Scattered Spider).

    Potential Emergence of New Ransomware

    On Oct. 4, 2025, the threat actors claimed to be developing a new form of ransomware named “SHINYSP1D3R” as noted in Figures 6 and 7. These posts appear to be related to observations previously noted by Falconfeeds in August 2025. It is currently unclear if the aforementioned ransomware is still under development or simply a false claim.

    Telegram screenshot: "It's time to make it clear to certain entities what real extortion looks like." The rest of the text lists other cybercrime groups and asks the readers to stay tuned on what's new.
    Figure 6. Screenshot of Telegram posts to SLSH 6.0 part 3 channel on Oct. 4, 2025. Source: Telegram.
    Telegram screenshot that says what is coming next is the GTA 6 of ransomware.
    Figure 7. Screenshot of Telegram posts to SLSH 6.0 part 3 channel on Oct. 4, 2025. Source: Telegram.

    What Comes Next — and What I Recommend You Do

    Given that the clearnet version of Scattered LAPSUS$ Hunters’ newly launched DLS is unavailable at this time, it is unclear if any of the victims listed on the site made a ransom payment to the threat actors.

    Additionally, it remains relatively uncertain if the EaaS program advertised by the threat actors will be as lucrative of a business model as they likely hoped it would be. Given that the advertisement specifically cites the removal of any file encryption in comparison to a traditional RaaS program, organizations may be less willing to make a ransom payment considering the potential lack of operational disruption.

    Finally, it is not evident why the threat actors would potentially be interested in operating both an EaaS and a RaaS program, other than attempting to diversify their revenue streams. This is certainly something Unit 42 will continue to monitor going forward.

    As noted in our previous Insights piece, the theft and leakage of PII, including loyalty program details (e.g., frequent flyer numbers) from some victim organizations (specifically those in hospitality) could enable cybercriminals to conduct identity theft and other types of fraud, including fueling the growth of fraudulent travel agencies advertised across underground cybercrime forums and Telegram channels.

    Given the rise of RaaS programs in recent years, many organizations have developed incident response playbooks specifically to prepare for a ransomware event in terms of operational disruption. I believe it is now time for organizations to create similar playbooks for the growing threat of EaaS programs, specifically to prepare for the reputational risks associated with such events. This should include having third-party experts on standby via retainer to assist with potential negotiations, verification of stolen data and other related actions.

    If your organization has been threatened with data theft extortion by Scattered Lapsus$ Hunters or other cybercriminals, the Unit 42 Incident Response team is here and ready to support with either a suspected compromise or to reduce the risk via a proactive threat assessment.

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  • The impact of fintech on lending

    Technology – especially AI – is disrupting the world of finance (see overviews in Duffie et al. 2022, Foucault et al. 2025, and Vives 2019). Lending is no exception: machine learning and large datasets are successfully used for credit assessment. Fintech has enabled efficiency gains, such as improved loan screening, monitoring, and processing, and has fostered financial inclusion among underserved populations and in less developed countries.

    At the same time, it raises concerns about financial stability, privacy, and discrimination. Digital technologies enable improved customer segmentation, which not only facilitates personalised services but also allows for finer price discrimination. The empirical evidence on fintech’s impact is mixed regarding loan pricing, substitutability or complementarity of fintech and bank credit, loan default, and data sharing.

    Empirical studies differ on whether default or delinquency rates are higher for fintech-originated loans than for bank-originated loans. While some report higher default rates (Di Maggio and Yao 2021), others report lower (Fuster et al. 2019), and still others find no significant difference (Buchak et al. 2018). Similarly, open banking initiatives increase the likelihood that SMEs form new lending relationships with non-bank lenders and reduce their interest payments. Still, they do not necessarily improve financial inclusion (Babina et al. 2024). However, in Germany (Nam 2023) and India (Alok et al. 2024), open banking has improved credit access on both extensive and intensive margins without increasing risk. In the US, California’s Consumer Privacy Act strengthened fintechs’ screening capabilities relative to banks and enabled more personalised mortgage pricing, ultimately reducing loan rates and improving financial inclusion (Doerr et al. 2023).

    An analytical framework

    In Vives and Ye (2025a, 2025b), my co-author and I present an analytical framework that incorporates key differences between fintech firms and incumbent banks, explains the mixed empirical findings in the literature, and delivers a welfare analysis. The framework introduces a taxonomy of how fintech affects frictions in the lending market. We find that fintech’s impact on competition and welfare hinges on its effect on the differentiation between financial intermediaries and the efficiency gap between them. Primary factors influencing market performance include the level of bank concentration, the intensity of competition among fintechs, the potential for price discrimination, the size of the unbanked population, and the convenience offered by fintechs.

    We consider a spatial oligopolistic competition model in which lenders (banks and fintechs) compete to provide loans to entrepreneurs. The framework captures key differences between fintechs and banks. For example, banks have more financial data and soft information (with relationship lending) than fintechs, but the latter have better information-processing technology and conversion of soft into hard information (with the digital footprint) and lower distance friction with borrowers. This distance can be physical or in terms of expertise; greater distance between a lender and borrower increases the cost of monitoring (or screening).

    Furthermore, banks have lower funding costs, and fintechs have higher convenience benefits. Fintechs also have greater price flexibility for technological and regulatory reasons, which gives them a competitive advantage. In the extreme, banks are differentiated by expertise (location), but fintechs are not; fintechs can price discriminate, whereas banks cannot. In our model, endogenous entrepreneur participation occurs at each location, and entrepreneurial projects require monitoring (screening) to enhance project returns (Vives and Ye 2025b) or to mitigate a moral hazard problem faced by entrepreneurs (Vives and Ye 2025a).

    The type of fintech advancement matters

    A key insight from Vives and Ye (2025a) is that we should distinguish between general advances in fintech that reduce the distance between lenders and borrowers and those that do not. General improvements in information collection and processing, such as enhanced data storage, computing power, or desktop software, do not necessarily reduce distance friction. Technologies that lower the effective distance between lenders and borrowers include improved internet connectivity, video conferencing, remote learning tools, AI, and advanced search engines, which enable lenders to expand their domain expertise and serve distant borrowers more effectively. Big data, together with machine learning, can improve both types of capabilities.

    If fintech does reduce the distance friction, lenders’ differentiation will decrease and competition intensity will increase, decreasing their profits and monitoring incentives. The effect is more pronounced when the entrepreneurs’ moral hazard problem is more severe. The impact on entrepreneurs’ investment and total welfare is hump-shaped. Those effects are not present when fintech progress does not affect the distance between lenders and borrowers.

    Bank and fintech competition

    In Vives and Ye (2025b), we assume that banks are differentiated by expertise (located in a circle) but fintechs are not (located in the virtual middle). We find that (1) fintech entry can be blockaded, remain as a potential threat, or materialise depending on fintechs’ monitoring efficiency, (2) fintech lending can substitute or complement bank lending depending on whether pre-entry banks competed or not, and (3) fintech entry and loan volume is higher when bank concentration is higher.

    Furthermore, if banks cannot price discriminate, a fintech with no advantage in terms of monitoring efficiency or funding costs can enter the lending market. If banks and fintechs have similar funding costs, for entrepreneurs with similar characteristics, banks’ loan rates and monitoring are higher than those of fintechs (and fintech borrowers are more likely to default). The latter result will change if fintechs have significantly higher funding costs than banks. If fintechs have a significant advantage in convenience, they will likely charge higher prices, while banks will conduct more thorough monitoring. Therefore, differences in funding costs, convenience benefits, and abilities to price discriminate may explain the variety of empirical results on loan defaults by banks and fintechs.

    Fintech entry may decrease entrepreneurs’ investment if competition within fintechs is not sufficiently intense. An intermediate level of competition intensity among fintechs is needed to ensure a welfare increase following fintech entry, to balance the incentives of borrowers and lenders.

    However, if banks can also discriminate, fintechs need an advantage in monitoring (or funding costs, although this is less probable) to penetrate the market. Finally, the threat or actual entry of fintechs can induce bank exit or restructuring, potentially reducing the intensity of lending competition and investment, but generating a welfare-improving option value effect.

    Policy implications

    We can derive some policy implications from the analysis. We know that price discrimination is a competitive weapon, but it will not necessarily be welfare optimal unless it extends the market. This is so also in our modelling. Socially optimal loan rates strike a balance between the incentives of entrepreneurs and intermediaries to exert effort, thereby mitigating moral hazard, encouraging entrepreneur participation in the market, and enhancing lenders’ monitoring or screening effort.

    However, this balance typically cannot be obtained from lender competition with location-based discrimination. For example, with endogenous entrepreneur participation at any location, a bank should charge (from a welfare perspective) higher rates for distant locations (since monitoring is more costly and distant locations generate less surplus). In contrast, price-discriminating banks will do the opposite in equilibrium to meet the competition. However, allowing banks to discriminate when fintechs price discriminate improves welfare when there is little inter-fintech competition.

    Regarding data sharing, we find that a policy (e.g. open banking) that benefits fintechs must be complemented by an appropriate degree of inter-fintech competition. Otherwise, the policy may backfire, and a leading fintech may gain a monopoly position in a market segment. Differences in the degree of competition may explain the differences in the empirical results in the impact of open banking.

    In summary, levelling the playing field (in terms of lenders’ ability to price discriminate and access to information) is a good policy aimed at achieving a degree of competition that induces a division of rents, thereby balancing the incentives of different market participants to maximise welfare. This degree of competition must be sufficient to prevent monopoly positions in market segments, while also ensuring that both lenders and borrowers have enough stake in the game.

    References

    Alok, S, P Ghosh, N Kulkarni, and M Puri (2024), “Open banking and digital payments: Implications for credit access”, working paper.

    Babina, T, S A Bahaj, G Buchak, F De Marco, A K Foulis, W Gornall, F Mazzola, and T Yu (2024), “Customer data access and fintech entry: Early evidence from open banking”, working paper.

    Buchak, G, G Matvos, T Piskorski, and A Seru (2018), “Fintech, regulatory arbitrage, and the rise of shadow banks”, Journal of Financial Economics 130: 453–83.

    Di Maggio, M, and V Yao (2021), “FinTech borrowers: Lax screening or cream skimming?”, The Review of Financial Studies 34: 4565–618.

    Doerr, S, L Gambacorta, L Guiso, and M Sanchez del Villar (2023), “Privacy regulation and fintech lending”, working paper.

    Duffie, D, T Foucault, L Veldkamp, and X Vives (2022), Technology and finance, The Future of Banking 4, CEPR Press.

    Foucault, T, L Gambacorta, W Jiang and X Vives (2025), Artificial intelligence in finance, The Future of Banking 7, CEPR Press.

    Fuster, A, M Plosser, P Schnabl, and J Vickery (2019), “The role of technology in mortgage lending”, The Review of Financial Studies 32: 1854–99.

    Nam, R J (2023), “Open Banking and Customer Data Sharing: Implications for Fintech Borrowers”, SAFE Working Paper No. 364.

    Vives, X (2019), “Digital disruption in banking”, Annual Review of Financial Economics 11: 243–72.

    Vives, X, and Z Ye (2025a), “Information technology and lender competition”, Journal of Financial Economics 163: 103957.

    Vives, X, and Z Ye (2025b), “Fintech entry, lending market competition, and welfare”, Journal of Financial Economics 168: 104040.

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  • Platform Insights: LinkedIn 2025 | WARC

    We’re long-term subscribers to WARC and it’s a tool we use extensively. We use it to source case studies and best practice for the purposes of internal training, as well as for putting persuasive cases to clients. In compiling a recent case for long-term, sustained investment in brand, we were able to support key marketing principles with numerous case studies sourced from WARC. It helped bring what could have been a relatively dry deck to life with recognisable brand successes from across a broad number of categories. It’s incredibly efficient to have such a wealth of insight in one place.

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  • Survey on Assessment of Health and Environmental Hazards and Risks of Surface-Treated Nanomaterials Will Close October 31, 2025

    Survey on Assessment of Health and Environmental Hazards and Risks of Surface-Treated Nanomaterials Will Close October 31, 2025

    The European Union (EU) Observatory for Nanomaterials (EUON) has contracted the Nanotechnology Industries Association (NIA) and Yordas Group to undertake a study on the assessment of health and environmental hazards and risks of surface-treated nanomaterials. The aim of the study is to review and collect scientific information and data on how surface treatment can affect the properties of nanomaterials and potentially have an impact of their fate and potential risks. The study includes a market survey to understand:

    • Which surface-treated nanomaterials can be found on the EU market and in which quantities; and
    • The industrial sectors or fields of application in which these surface-treated nanomaterials are being used.

    To supplement other data gathering and help qualify data found using different sources, the survey seeks to gather people’s direct knowledge of this field. The survey is open to anyone with knowledge of the manufacturer or use of surface-treated nanomaterials within the EU. This may include manufacturers or suppliers of surface-treated nanomaterials, end users of surface-treated nanomaterials, researchers aware of surface-treated nanomaterials, or laboratories, service providers, or research and training organizations with knowledge of surface-treated nanomaterials. The survey will close October 31, 2025. Bergeson & Campbell, P.C. is a proud member of the NIA.

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  • Pinsent Masons welcomes Fernando Tallón Martínez as a new partner

    Pinsent Masons welcomes Fernando Tallón Martínez as a new partner

    Pinsent Masons has welcomed Fernando Tallón Martínez, formerly of Ramón y Cajal, as a new partner in Litigation and Arbitration in Madrid.

    Francisco Aldavero, managing partner of Pinsent Masons in Spain, said: “In the current context of modernization of the Spanish judicial system, our clients—both domestic and international—require the best possible advice to navigate a constantly evolving regulatory framework. Fernando’s arrival strengthens our ability to remain a benchmark for our clients, even in a constantly changing legal landscape.”

    Photo by Juan Manuel Guzmán: Fernando Tallón Martínez and Francisco Aldavero, managing partner of Pinsent Masons

    Fernando Tallón Martínez

    With a solid track record in resolving complex civil and commercial disputes, often on an international scale, Tallón has extensive experience in contractual and non-contractual liability cases, both in court proceedings and in domestic and international arbitration.

    His experience covers a wide range of complex disputes, including those relating to construction contracts and commercial agreements. In addition, he advises on a wide variety of commercial dispute matters, including restructurings, insolvency proceedings, claims for damages arising from competition law infringements, and class actions.

    In terms of sector expertise, Tallón has solid specialization in the energy, financial services, construction, hospitality, insurance, real estate, and agri-food sectors, which constitute his main areas of activity.

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  • BHP Operational Review for the quarter ended 30 September 2025

    BHP Operational Review for the quarter ended 30 September 2025

    BHP Operational Review for the quarter ended 30 September 2025 (PDF 132kb)

    BHP Operational Review for the quarter ended 30 September 2025 – Excel (Excel 491kb)

    BHP Chief Executive Officer, Mike Henry:

    “We’ve made a strong start to the year, highlighted by disciplined operating performance and execution of scheduled maintenance. Group copper production rose 4%, with record concentrator throughput at Escondida.

    In iron ore, WAIO delivered another standout quarter, achieving record material mined while completing critical infrastructure upgrades ahead of schedule.

    In steelmaking coal, production rose 8%, supported by strong mining rates at Broadmeadow and increased stripping at our open cut mines. We progressed key growth and decarbonisation milestones in the quarter, including securing environmental approval for the Laguna Seca Expansion at Escondida and Copper South Australia entering into its largest renewable electricity agreement.

    Both stages of the Jansen potash project in Canada are advancing, with Stage 1 reaching 73% completion and on track for production to begin in 2027, while Stage 2 is now 13% complete. The long-term demand fundamentals for potash are attractive and Jansen is expected to be one of the lowest cost producers.

    Overall macro-economic signals for commodity demand remain resilient, and global growth forecasts are moving higher. While we expect some deceleration in growth in H2 CY25, in China we still expect GDP growth of ~5% for the year. In copper, major disruptions at some of our competitors’ mines have tightened overall market fundamentals, benefitting our world-class portfolio of assets.

    With momentum from a strong first quarter, BHP is on track to deliver on full-year guidance and we are making progress on our growth pipeline across Australia and the Americas.”

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  • Revealing the Invisible: How Bangkok’s BEYC teaches clean air awareness

    British Early Years Centre (BEYC) in Bangkok is a school known for its innovative educational approaches and nature-based learning philosophy. Through the use of an IQAir AirVisual Monitor, this international kindergarten helps protect students from air pollution while sparking awareness about the environment (1).

    An environment built for health, safety, and discovery

    Located in the family-friendly Ari neighborhood, BEYC caters to children ages 2 to 6, blending the British Early Years Foundation Stage Curriculum with Reggio Emilia principles like child-led learning and hands-on exploration.

    “Our philosophy is that the environment is the third teacher,” says Ms Liv, Head of School at BEYC. “If air quality is part of our environment, then understanding it becomes part of the learning journey.”

    For BEYC, air quality monitoring is a natural extension of its broader health-first policies. From its allergen-controlled campus and gluten-free meals to the use of natural materials and handmade organic soaps, BEYC’s daily operations reflect a commitment to child wellness.

    How air quality data shapes daily decisions

    Air quality data from the school’s IQAir AirVisual Monitor plays a practical role in daily safety decisions. When PM2.5 levels rise, teachers take swift action—adjusting outdoor play schedules, moving activities indoors, and ensuring windows remain closed to limit exposure.

    “Our air quality monitor gives us clear, real-time information we can act on,” explains Liv. “It makes invisible risks visible—for both teachers and families.”

    Staff members regularly reference the AQI (Air Quality Index) before outdoor play, and families are encouraged to check the school’s public air quality feed online, thanks to BEYC’s participation on IQAir’s AirVisual platform.

    Turning air quality into a teachable moment

    At BEYC, air quality monitoring isn’t just about risk mitigation—it’s also a learning tool. The Reggio Emilia philosophy emphasizes following children’s natural curiosity, and the AirVisual monitor often sparks questions from students:

    • “Why is the air red today?”
    • “What does PM2.5 mean?”
    • “How can we make the air better?”

    Teachers use these moments to introduce age-appropriate discussions about pollution, environmental responsibility, and how children can help care for their world.

    “Even at this young age, our students are beginning to make the connection between what they see on the air quality display and the choices we make that day,” says Liv. “That’s powerful learning.”

    Community impact beyond the classroom

    BEYC’s air quality station doesn’t just serve the school. With nearly 35,000 followers, their IQAir contributor profile has become a primary resource for the community to understand local air quality.

    “It’s incredible to think our data is helping so many people make important daily decisions about their health,” Liv said. “The platform makes sharing our data simple and meaningful,” says Liv. “It allows us to help families here in our area—and contributes to the wider air quality conversation globally.”

    With nearly 35,000 followers, their IQAir contributor profile has become a primary resource for the community to understand local air quality.

    BEYC’s participation is part of IQAir’s global school air monitoring initiative, a growing network of educational institutions helping to build one of the world’s most comprehensive air quality data networks.

    Conclusion

    British Early Years Centre shows that air quality awareness and education aren’t just for older students. By integrating IQAir’s monitoring technology into its health policies and curriculum, BEYC is equipping young learners with tools for understanding and protecting their well-being.

    In Bangkok, where pollution is a concern, BEYC stands as an example of how schools can empower children and families to make informed, healthy choices—one data point, one teaching moment, and one curious question at a time.

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  • Insurance and Tolerability Factors Considered in Recurrent RCC Treatment | Targeted Oncology

    Insurance and Tolerability Factors Considered in Recurrent RCC Treatment | Targeted Oncology

    Immunotherapy (IO) and tyrosine kinase inhibitor (TKI) combination regimens have dramatically changed outcomes for patients with metastatic clear cell renal cell carcinoma (RCC). Now, clinical experience and research are providing better guidance on how to respond when patients’ disease recurs after the use of combination therapy. In a virtual Case-Based Roundtable event for oncologists in Oklahoma and Texas, moderator Nizar M. Tannir, MD, professor of genitourinary medical oncology at The University of Texas MD Anderson Cancer Center in Houston, presented data on second-line treatment and beyond and asked participants to share their experiences. They discussed how many of their patients are able to delay subsequent treatment for several years thanks to frontline combinations and also considered the barriers to use for the newer agents tivozanib (Fotivda) and belzutifan (Welireg).

    Register today to join a Case-Based Roundtable near you.

    This article is part 2 of a 2-part series from a Case-Based Roundtable event.

    DISCUSSION QUESTIONS

    • What is your reaction to the efficacy data from the phase 3 TiNivo-2 study (NCT04987203)? ​
      • The nivolumab (Opdivo) plus tivozanib combination arm?​
      • The tivozanib monotherapy arm?​

    Nizar M. Tannir, MD: Vis-a-vis the combination arm; we already know that the combination should not be given after a prior therapy with nivolumab/ipilimumab or an IO/TKI. But what do you take out of this monotherapy arm with 9.2 months’ median progression-free survival [PFS] in patients who received 1.34 mg tivozanib as second line?1 Do you consider these results to be clinically meaningful, practice changing, or practice confirming?

    Stephen Barman, MD: I think it depends on what you use in the first line. I use a lot of nivolumab plus ipilimumab [Yervoy] in the first line, unless…I need a very quick response in the first line, [or] somebody’s got significant hypoxia from lung disease; then I like to use a TKI. I still like cabozantinib [Cabometyx] in the second line and tivozanib more in the third line. Do you think that the FDA will update the indication in the second line?

    Tannir: You bring up a very important point. Tivozanib is approved after at least 2 [prior therapies]. It’s not approved after only 1 line. The approval is based on the TIVO-3 trial [NCT02627963] vs sorafenib [Nexavar], and that trial required patients to have had 2 or 3 prior lines. Only 26% of those patients had [received] immune checkpoint inhibitors.2 The approval and the package insert [require that the patient] had to have received 2 lines, meaning the patient had to have an IO and a TKI.3 So…nivolumab/ipilimumab is considered dual immunotherapy in 1 line. Technically speaking, you’re going to have a hard time with insurance approving tivozanib after nivolumab/ipilimumab.

    This is an important question. I think the data are impressive for tivozanib as a second line after nivolumab/ipilimumab with an 32% objective response rate and median PFS of 9.2 months.1 I like to prescribe this regimen because I like to give my patients an agent that’s well tolerated. When you look at hand-foot syndrome, mucositis, fatigue—except for hypertension—tivozanib doesn’t produce much of that compared with cabozantinib or lenvatinib [Lenvima] plus everolimus [Afinitor]. Even axitinib [Inlyta] causes more mucositis and hand-foot syndrome and liver toxicity, etc. Tivozanib, despite its long half-life, is very well tolerated compared with the other TKIs.

    Rebecca Yarborough, MD: I have an older, frailer population as well, so I don’t use as much combination immunotherapy in my patients, unless they’re fitter or younger, and sometimes with more aggressive pathologies, such as sarcomatoid…. I use a lot of IO/TKI in the first line. A lot of times I go to cabozantinib in the second line. I’ve been in practice for 3 or 4 years, so I don’t have any patients beyond second line in my practice right now, so I haven’t had a chance to use tivozanib or belzutifan yet. I think it was very interesting to see the tivozanib data…. I would like to be able to use that more. I’m interested in its better tolerability compared with cabozantinib.

    Parth Khade, MD: I thought it was significant in the sense that it favors supporting monotherapy as opposed to immune checkpoint inhibition rechallenge with the combination arm, resulting in slightly lower median PFS, but I think it also supports using tivozanib as monotherapy [with] the expected response rate in a multicenter trial looking at a diverse patient population. I think it gives good evidence that tivozanib is effective. The question just becomes what line of therapy to use it in, whether it’s third line, second line, etc.

    Tannir: I can tell you, the earlier line you use any TKI is going to be a better result. If you wait for third or fourth line, your efficacy is going to drop, or radiographic PFS will be [shorter].

    DISCUSSION QUESTIONS

    • What are your reactions to the final analysis data from LITESPARK-005 (NCT04195750)? ​
      • Do you consider them practice changing or practice confirming?​
      • What do you think about the toxicity profile of belzutifan? ​

    Dai Chu Luu, MD: I think this is just practice confirming. When I think about how to choose between the 2, I’d pick tivozanib; it seems to be better tolerated. Of course, [belzutifan] was studied in a later line. With belzutifan it looks like anemia was a pretty big adverse event, whereas tivozanib seem to be well tolerated.1,4

    Khusroo Qureshi, MD: All these things are very impressive. When I started [practicing] oncology and was in fellowship 25 years ago, we used to use IL-2, so when you compare it with interleukin therapy, all these things are very impressive. At Texas Oncology, we use a lot of pathways to guide us. My frontline therapy often is axitinib and pembrolizumab [Keytruda]. I’ve had patients tolerate axitinib quite well. Sometimes I’ve had issues with skin rash or diarrhea, and I just have them hold it if it’s really bad or just skip the weekends and it’s pretty well tolerated. Right now, I think I have 4 or 5 patients on first-line therapy for metastatic RCC, and they’re all doing really well. Some of them have been on therapy for over 1 year. For second-line therapy, cabozantinib would still be my preferred [option].

    The data…including the singlet [tivozanib] vs tivozanib plus IO are very convincing, but it’s still not approved for second-line therapy, and we get a lot of pushback regarding whether something is on Compendia and whether it’s approved or not. Unless there’s a change, I probably would still hold tivozanib for the third line. As far as fourth line and belzutifan…I’ve not had a chance to use that. In the past, when I’ve had patients reach that point, I’ve sent patients to my colleague who runs our phase 1 research programs and I send patients to Mary Crowley Cancer Research [in Dallas, Texas] to see what else is available. But so far, I’ve had an excellent response on my first-line therapies, so I have not even had a chance to use a second line in the last 18 to 24 months.

    Ofobuike Okani, MD: I have the same experience at Texas Oncology. I treated a 68-year-old patient close to 3 years ago, and he had clear cell metastatic RCC. He received 24 months of pembrolizumab/axitinib and I stopped at 24 months. He still has no evidence of disease on all his scans. I treated another 89-year-old patient who couldn’t tolerate pembrolizumab/axitinib. He had liver toxicity which was pretty bad, so I kept him on only axitinib, and he’s doing well at 89 years old. Another patient with metastatic clear cell RCC is on maintenance pembrolizumab for close to 9 months. I have another patient who is in his 40s, who is getting axitinib/pembrolizumab, and he’s doing very well. The only patient I have treated with second-line cabozantinib was a patient I treated with The University of Texas MD Anderson Cancer Center, but other than that, I’ve never gone beyond the second line, so I have not used tivozanib. I have not had any experience with any of these agents treating beyond the second line.

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    DISCLOSURES: Tannir previously reported research funding from Bristol-Myers Squibb Company (BMS), Calithera Biosciences, Nektar Therapeutics, Exelixis, Pfizer, Novartis, Arrowhead Pharmaceuticals, Mirati Therapeutics, Takeda, Epizyme, and Eisai Medical Research; consulting, advisory, travel accommodations, and expenses from BMS, Calithera Biosciences, Nektar Therapeutics, Exelixis, Pfizer, Novartis, Eisai Medical Research, Ipsen, Lilly Oncology, Neoleukin Therapeutics, Surface Oncology, ONO Pharmaceutical, and Oncorena; and honoraria from BMS, Exelixis, Nektar Therapeutics, Calithera Biosciences, Eisai Medical Research, ONO Pharmaceutical, Eli Lilly, Oncorena, Ipsen, and Surface Oncology.

    References:

    1. Choueiri TK, Albiges L, Barthélémy P, et al. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 study. Lancet. 2024;404(10460):1309-1320. doi:10.1016/S0140-6736(24)01758-6

    2. Rini BI, Pal SK, Escudier BJ, et al. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020;21(1):95-104. doi:10.1016/S1470-2045(19)30735-1

    3. Fotivda. Prescribing information. Aveo Pharmaceuticals; 2021. Accessed October 20, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212904s000lbl.pdf

    4. Choueiri TK, Powles T, Peltola K, et al. Belzutifan versus everolimus for advanced renal-cell carcinoma. N Engl J Med. 2024;391(8):710-721. doi:10.1056/NEJMoa2313906

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  • Gilead to spotlight new virology data across HIV, viral hepatitis and respiratory diseases at IDWeek 2025

    Gilead to spotlight new virology data across HIV, viral hepatitis and respiratory diseases at IDWeek 2025

    – Additional Phase 3 PURPOSE data reinforce the safety profile of twice-yearly Yeztugo® as an effective HIV prevention option across diverse populations –

    – New data show higher treatment satisfaction after switching from IM CAB+RPV to Biktarvy® –

    – New research reaffirms Veklury® in high-risk COVID-19 populations and obeldesivir in emerging pathogens –

    Read the full company press release here.

     

    Source : Gilead Sciences, Inc.

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