Aviva (LSE:AV.) shares have seen mixed performance recently, coming off a recent dip of about 1% in the past day and sliding 3% over the past month. The stock’s year-to-date gain remains firmly positive, which raises questions about its current valuation ahead of further catalysts.
See our latest analysis for Aviva.
Over the past year, Aviva has delivered a robust 42% total shareholder return, even as recent weeks have seen the share price ease off its highs. This momentum points to solid long-term confidence in the company’s progress, despite short-term fluctuations and shifting market sentiment.
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With solid returns and recent pullbacks, the big question now is whether Aviva is trading at a bargain or if the market has already factored in all the anticipated growth, leaving little room for upside.
Aviva’s latest fair value is slightly above its last close, suggesting a mild undervaluation that could be important for investors seeking upside. The narrative points to structural industry shifts and business transformations as the foundation for this forward-looking valuation.
*Accelerating the shift to ‘capital-light’ businesses (now over 66% of earnings and targeting 70% or more after the Direct Line integration) is driving improved group profit margins, lower capital requirements, and better return on equity. This creates a strong forward-looking outlook for net earnings and cash generation.*
Read the complete narrative.
Curious how a strategic pivot in business mix could fuel margin gains? The fair value estimate draws on some game-changing growth and profitability forecasts. Want to uncover the combination of ambitious projections and future assumptions behind that price? The real rationale is one click away.
Result: Fair Value of £6.84 (UNDERVALUED)
Have a read of the narrative in full and understand what’s behind the forecasts.
However, risks such as slower revenue growth or execution challenges with recent acquisitions could undermine these favorable margin and valuation forecasts for Aviva.
Find out about the key risks to this Aviva narrative.
While the latest fair value suggests Aviva is undervalued, looking at the price-to-earnings ratio paints a different picture. At 32.9x, Aviva’s ratio is much higher than the UK insurance industry average of 12.8x and a fair ratio of 22.4x. This sizeable gap suggests there may be greater valuation risk and raises the question of whether the market could quickly adjust if sentiment shifts.
See what the numbers say about this price — find out in our valuation breakdown.
LSE:AV. PE Ratio as at Nov 2025
If you have your own perspective or want to dig deeper into Aviva’s story, you can shape your own analysis in just a few minutes, and Do it your way.
A great starting point for your Aviva research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.
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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 AV.L.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
Warren Buffett published his last annual address as CEO of Berkshire Hathaway (NYSE:BRK, BRK.B)) earlier this week, urging the company’s “unusually generous” shareholders to act kindly and decently in an increasingly greedy world.
“Greatness does not come about through accumulating great amounts of money, great amounts of publicity or great power in government,” the billionaire investor wrote.
“When you help someone in any of thousands of ways, you help the world,” he continued. “Kindness is costless but also priceless. Whether you are religious or not, it’s hard to beat The Golden Rule as a guide to behavior.”
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For decades, Buffett has been dispensing life advice in his missives to shareholders, which has helped establish him not just as an accomplished businessman, but also as someone who has mastered the secrets to living a better life.
“I write this as one who has been thoughtless countless times and made many mistakes but also became very lucky in learning from some wonderful friends how to behave better (still a long way from perfect, however),” he continued.
“My advice: Don’t beat yourself up over past mistakes — learn at least a little from them and move on,” he wrote. “It is never too late to improve. Get the right heroes and copy them. You can start with Tom Murphy; he was the best.”
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Murphy spent decades as the CEO of Capital Cities Communications and was one of the masterminds behind the broadcaster’s merger with ABC and eventually Disney (NYSE:DIS). He was a close friend of Buffett’s and served on Berkshire Hathaway’s board until 2022, when he resigned following a battle with COVID. He died later that year.
Buffett’s letter to shareholders comes at a similar transition point in his career. In May, he announced that he’d be stepping down as CEO of Berkshire Hathaway by the end of the year, naming long-time lieutenant Greg Abel as his successor.
“I will continue talking to you and my children about Berkshire via my annual Thanksgiving message,” he continued. “Berkshire’s individual shareholders are a very special group who are unusually generous in sharing their gains with others less fortunate. I enjoy the chance to keep in touch with you.”
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At 95, Buffett has long surpassed traditional retirement age. While he wrote that he “generally feel[s] good,” he acknowledged that physical diminishment has pushed him to a point where a step back is necessary.
“When balance, sight, hearing and memory are all on a persistently downward slope, you know Father Time is in the neighborhood,” he wrote.
Age may have impacted his ability to put in the long weeks, but it’s only increased his wisdom, he said.
“Choose your heroes very carefully and then emulate them. You will never be perfect, but you can always be better,” was his closing advice.
Read Next: Wall Street’s $12B Real Estate Manager Is Opening Its Doors to Individual Investors — Without the Crowdfunding Middlemen
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This article ‘Kindness Is Costless But Also Priceless,’ Warren Buffett Urges Decency In His Annual Address originally appeared on Benzinga.com
Microsatellite-stable metastatic colorectal cancer remains one of the most difficult treatment settings in solid tumor oncology, especially after progression on standard cytotoxic and biologic therapies. Nearly 95% of colorectal cancers are MSS, and these tumors are largely resistant to immunotherapy, leaving clinicians with regorafenib or trifluridine/tipiracil as the primary later-line treatment options, both of which provide modest benefit and substantial toxicity (Grothey et al., Lancet, 2013). The development of zanzalintinib, a next-generation multi-kinase inhibitor designed by Exelixis, reflects growing interest in overcoming angiogenic and microenvironment-driven resistance mechanisms in MSS disease.
Read About Colorectal Cancer on OncoDaily
Mechanism of Action
Zanzalintinib (formerly XL092) is an oral tyrosine kinase inhibitor that targets VEGFR2, MET, AXL, and members of the TAM kinase family. These pathways regulate angiogenesis, tumor invasiveness, metastatic potential, and immune suppression. By inhibiting VEGFR2 and MET simultaneously, the drug counteracts key escape mechanisms frequently observed with earlier anti-angiogenic agents. Inhibition of AXL further reduces epithelial–mesenchymal transition, a process responsible for metastasis and therapy resistance. Early pharmacokinetic modeling indicates that zanzalintinib’s shorter half-life and improved kinase selectivity may lead to more predictable exposure and better tolerability compared with cabozantinib, its predecessor (Gao et al., Clin Cancer Res, 2021).
Why MSS Colorectal Cancer Responds to Zanzalintinib
MSS CRC is aggressive, immunologically cold, and resistant to checkpoint inhibitors.
Key features include:
low mutation burden
high angiogenesis
robust immune exclusion
strong EMT and metastasis signatures
upregulated MET/AXL signaling
These are precisely the pathways zanzalintinib inhibits.
By reducing angiogenesis while reversing MET- and AXL-driven immune evasion, zanzalintinib:
decreases tumor hypoxia
improves T-cell infiltration
reduces metastatic behaviors
enhances immune priming
This gradually converts immunologically cold tumors into more susceptible ones.
The STELLAR-303 Trial
The phase III STELLAR-303 trial evaluated zanzalintinib in previously treated MSS metastatic colorectal cancer. The trial enrolled patients who had progressed on fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab—with anti-EGFR therapy incorporated for RAS wild-type tumors—thus representing a heavily pretreated population with limited clinical options. Patients were randomized to receive either zanzalintinib or regorafenib, the established VEGF-targeting agent in this setting.
STELLAR-303 demonstrated that zanzalintinib improved overall survival and progression-free survival compared with regorafenib, marking one of the first meaningful advances in MSS colorectal cancer in nearly a decade. The survival benefit was consistent across key subgroups, including patients with liver metastases, a group known to derive limited benefit from immunotherapy (STELLAR-303 Investigators, ASCO GI, 2025).
While the detailed numerical OS and PFS values are still pending full publication, investigators reported a clinically meaningful improvement in disease control, with more durable responses and fewer early discontinuations compared with regorafenib.
Read About STELLAR-303 Trial on OncoDaily gi
Safety and Tolerability
The safety profile of zanzalintinib reflects the expected pattern of multi-target anti-angiogenic therapies, with hypertension, fatigue, diarrhea, and hand–foot syndrome among the more common adverse events. However, treatment-emergent toxicity appeared more manageable compared with regorafenib, which has historically been limited by dose-limiting hand–foot syndrome and gastrointestinal side effects.
The improved tolerability is attributed to the optimized kinase selectivity and shorter half-life of zanzalintinib, which allow for more consistent exposure and easier dose adjustments. Fewer grade ≥3 adverse events were reported in the zanzalintinib arm, and dose reductions occurred less frequently than with regorafenib (STELLAR-303 Investigators, ASCO GI, 2025). This tolerability advantage could translate into better treatment adherence and longer therapy duration, both of which are critical in later-line metastatic settings.
Clinical Significance
Zanzalintinib addresses several longstanding challenges in MSS metastatic colorectal cancer. The drug directly targets pro-angiogenic and mesenchymal signaling pathways that drive disease progression in MSS tumors, offering a biologically rational approach where traditional cytotoxic therapy provides diminishing returns. Because immunotherapy remains ineffective in nearly all MSS tumors, and because resistance to VEGF blockade is nearly universal, the introduction of a next-generation TKI with multi-pathway inhibition represents an important therapeutic evolution.
Given the persistent lack of innovation in later-line MSS CRC, the improvement in overall survival observed in STELLAR-303 positions zanzalintinib as a potential new standard of care after progression on first- and second-line therapies.
Future Directions and Combination Approaches
Preclinical data suggest that dual VEGFR2/MET blockade may enhance antitumor immunity by improving dendritic cell activation and reducing immunosuppressive signaling in the tumor microenvironment (Feng et al., Cancer Res, 2022). These findings support ongoing studies evaluating zanzalintinib in combination with checkpoint inhibitors, particularly in MSS colorectal cancer, where immune resistance is dominant.
Additional studies are exploring zanzalintinib in other tumors where MET or AXL signaling plays a role, including renal cell carcinoma, hepatocellular carcinoma, and select sarcoma subtypes. As full data from STELLAR-303 mature and additional combination studies read out, zanzalintinib may join the expanding class of rational multi-target TKIs designed to overcome the biological redundancy that characterizes advanced solid tumors.
Conclusion
Zanzalintinib represents a meaningful step forward in the treatment of MSS metastatic colorectal cancer, a disease setting with historically limited therapeutic progress. With improved survival, better tolerability than regorafenib, and a mechanism that addresses multiple resistance pathways simultaneously, the drug offers a rational and clinically impactful option for heavily pretreated patients. As future trials explore its synergy with immunotherapy and its applicability in other solid tumors, zanzalintinib may become a central component of modern targeted therapy strategies.
RTX Corporation (formerly Raytheon Technologies) is one of the world’s largest aerospace and defense companies, created through the merger of Raytheon and United Technologies. The company operates through three major segments: Collins Aerospace, which supplies aircraft systems, avionics, and interiors; Pratt & Whitney, known for its advanced jet engines and geared-turbofan technology; and Raytheon, a global leader in defense electronics, missile systems, radar, and intelligence solutions.
This dual-engine structure, balancing commercial aerospace with defense and government programs, gives RTX a uniquely diversified revenue base. The commercial side captures cyclical growth tied to global air travel and fleet modernization, while the defense portfolio provides steady, long-term cash flows supported by government budgets and multi-year contracts. This blend offers resilience through market cycles and positions RTX as a rare large-cap player with both growth and stability within the aerospace-defense sector.
RTX posted another strong quarter, with adjusted revenue of US$22.48 billion, up roughly 12 % year-on-year and ahead of consensus estimates of about US$21.3 billion. Organic growth stood at approximately 13 %, reflecting broad-based momentum even after accounting for divestitures. Adjusted EPS rose 17 % to US$1.70 versus US$1.45 in Q3 2024, while GAAP EPS came in at US$1.41, including about US$0.29 in acquisition-related adjustments. Free cash flow more than doubled to US$4.0 billion, underscoring improved execution and working-capital efficiency.
The company’s backlog climbed to a record US$251 billion, of which US$148 billion is from commercial programs and US$103 billion from defense, providing multi-year revenue visibility. Collins Aerospace delivered US$7.62 billion in sales (+8 %) and US$1.19 billion in operating profit (+9 %), supported by strong commercial OE (+16 %) and aftermarket (+13 %) growth. Pratt & Whitney reported US$8.42 billion in sales (+16 %) and US$751 million in profit (+26 %), led by a 23% surge in aftermarket and 15% military growth. Raytheon posted US$7.05 billion in sales (+10%) and US$859 million in profit (+30%), driven by robust demand across land, air, and naval defense programs.
Reflecting this performance, management raised full-year 2025 guidance. Adjusted sales are now expected to be between US$86.5 and 87.0 billion (up from US$84.7585.5 billion), and adjusted EPS to be between US$6.10 and 6.20 (up from US$5.805.95), while maintaining free cash flow guidance at US$7.07.5 billion.
RTX’s growth momentum remains strong across both commercial and defense segments. Collins Aerospace posted 16% OE and 13% aftermarket growth, reflecting a sustained aviation rebound, rising MRO activity, and airlines’ push for fuel-efficient upgrades. On the defense side, Raytheon secured about US$37 billion in new awards, lifting the total backlog to a record US$251 billion. Heightened global tensions and steady defense spending continue to support demand for RTX’s missile, radar, and command-and-control systems. With smoother production, supply-chain normalization, and stronger backlog conversion, management’s raised sales and EPS guidance underscores improving execution and free-cash-flow visibility through 2026.
That said, RTX still faces margin and execution risks. Input-cost inflation, especially in metals and electronics, could pressure profitability, while Pratt & Whitney’s rapid ramp-up in engine programs raises supply-chain and quality-control challenges. The commercial aviation rebound also remains cyclical and exposed to macro volatility. Even so, RTX enters the next phase from a position of strength, supported by solid demand, rising efficiency, and consistent FCF generation. If it sustains this operational rhythm, the premium valuation appears warranted, cementing RTX’s place among the most balanced and resilient aerospace and defense players globally.
Global defense spending continues to rise, giving RTX a durable structural tailwind and long-term earnings visibility. With defense budgets expanding across the U.S., Europe, and Asia, RTX’s Raytheon division stands to benefit from its leadership in missile defense, radar, and command-and-control systems. The company’s US$37 billion in new awards during Q3 and a record US$251 billion backlog highlight its deep integration in next-generation defense platforms and multi-year contracts that enhance revenue predictability and cash-flow resilience. On the commercial side, the aviation recovery is led by fleet modernization in Asia and India is driving sustained growth for Pratt & Whitney’s GTF engines and Collins Aerospace’s avionics and systems. This blend of cyclical commercial exposure and steady defense revenues gives RTX rare diversification and stability among aerospace peers.
Looking ahead, RTX’s focus on technology innovationhybrid-electric propulsion, next-gen missile systems, and digital avionics, adds optional upside to its intrinsic value. The path forward hinges on flawless execution: timely backlog conversion, operational efficiency, and continued R&D leadership. RTX’s premium valuation reflects high confidence in its ability to deliver; maintaining that trust will depend on consistent performance and disciplined capital allocation in both its commercial and defense businesses.
RTX Corporation: Strong Execution and Backlog Momentum, but Valuation Stretched vs Peers
Lockheed Martin (NYSE:LMT): Similar Scale, Lower Growth, Higher Cash Efficiency
Lockheed Martin remains RTX’s closest peer in scale and end-market exposure, though its revenue base leans more purely toward defense programs. In Q3 FY2025, Lockheed reported US$18.6 billion in sales (+9% YoY) and free cash flow of US$3.3 billion, representing an FCF margin near 17%. RTX outpaced Lockheed in both top-line growth (+12%) and cash generation (+104% YoY), signaling stronger post-pandemic commercial recovery leverage through Collins Aerospace and Pratt & Whitney. However, Lockheed’s backlog of US$179 billion remains highly defense-concentrated, offering steadier predictability and less exposure to commercial cyclicality. Its ROIC (~13%) is higher than RTX’s mid-single-digit level, indicating more efficient capital allocation. While RTX shows higher momentum in revenue and FCF efficient operator.
General Dynamics (GD): Stable Performer, Lower Growth but Leaner Valuation
General Dynamics is a diversified defense contractor spanning aerospace (Gulfstream), combat systems, marine systems, and IT services. For the same quarter, GD delivered ~US$11.5 billion in revenue (+6% YoY) with operating margins around 10%, roughly half of RTX’s growth rate. Its backlog stood near US$93 billion, materially smaller than RTX’s US$251 billion. The primary difference lies in exposure, GD’s business model is heavily defense-weighted with corporate aviation as the only cyclical leg. RTX’s mix gives it greater near-term growth potential but also higher volatility. In valuation terms, GD trades near 19 forward earnings, well below RTX’s 29, reflecting investor preference for RTX’s growth narrative but also GD’s stronger value case. Compared to GD, RTX offers superior organic expansion and margin recovery potential, though at a much higher multiple that assumes flawless execution.
Northrop Grumman (NOC): Margins Lead, Growth Lags
Northrop Grumman reported ~US$10.5 billion in Q3 sales (+7% YoY), with an operating margin of ~11% and a backlog near US$78 billion. Its growth pace trails RTX, but Northrop continues to lead in margin quality and contract profitability. The company’s exposure to classified programs and missile defense yields a steadier earnings base but limits growth acceleration in the near term. RTX, by contrast, enjoys both defense growth and a commercial aerospace rebound, giving it a broader runway for double-digit revenue expansion. However, that same dual exposure also brings higher cyclicality and integration risk. While Northrop’s FCF yield (~3.5%) is below RTX’s post-Q3 run-rate (~4.5%), its lower volatility and balanced contract structure keep it favored among conservative defense investors. Overall, RTX’s growth leadership comes at the expense of higher expectations and a premium valuation versus NOC’s steadier, more predictable model.
From a capital discipline standpoint, RTX’s return on invested capital (ROIC) of roughly 89% sits broadly in line with Lockheed Martin (~9%) and General Dynamics (~8%), indicating comparable cash efficiency rather than clear outperformance. This parity underscores that the current valuation premium is rooted more in growth expectations than in any structural capital-return advantage.
In relative terms, RTX is outgrowing all major U.S. defense peers, expanding its top line faster and showing stronger near-term free-cash-flow momentum. Its US$251 billion backlog also surpasses peers both in size and diversification. However, the company’s forward P/E of ~29 versus peer averages of 1921 reflects that the market already prices in superior execution, margin recovery, and steady cash conversion. The trade-off is clear: RTX’s commercial leverage offers cyclical upside, while Lockheed, GD, and NOC represent steadier but slower compounding models. For investors seeking growth within aerospace and defense, RTX remains the sector leader; for value and stability, its peers may offer better entry risk-reward at current multiples.
Notably, GuruFocus data indicates relatively limited involvement from well-known value investors in RTX at present. While large institutions and index funds maintain sizable passive holdings, few high-conviction value managers, such as Warren Buffett (Trades, Portfolio), Seth Klarman (Trades, Portfolio), or Tom Gayner (Trades, Portfolio), hold material positions. In contrast, peers like Lockheed Martin and General Dynamics feature more prominent ownership among long-term value funds. This muted participation suggests that while the market is pricing RTX for growth, disciplined value investors may be waiting for a more attractive entry point or greater proof of sustained free-cash-flow expansion before committing capital.
RTX’s latest results reaffirm its position as one of the most balanced and execution-driven players in global aerospace and defense. Its integrated commercialdefense model, blending Pratt & Whitney’s propulsion innovations, Collins Aerospace’s avionics, and Raytheon’s defense systems, enables technology sharing and scale efficiencies that few peers can replicate. In capital terms, RTX’s ROIC of around 89% remains comparable to peers like Lockheed Martin and General Dynamics, reflecting disciplined but not superior efficiency. This makes growth execution, rather than margin dominance, the critical driver of future value. Interestingly, GuruFocus data shows relatively limited participation from well-known value investors, which could help explain the valuation stretch, a market that’s confident in growth but cautious on cash realization.
With shares trading near 29 forward earnings, RTX’s valuation assumes continued backlog conversion, double-digit EPS growth, and expanding free cash flow. If the company sustains these trends, its intrinsic value could converge toward the upper end of the $195225 range. But given the high expectations, even minor execution shortfalls could trigger multiple compressions. RTX remains a high-quality compounder with durable tailwinds, but at current levels, conviction requires faith in flawless delivery rather than undervaluation.
India is entering a phase of rapid economic growth, with markets, innovation, and investment opportunities expanding at an unprecedented pace. For individuals under 40, this creates a unique chance to build substantial wealth if approached strategically. Chartered accountant Nitin Kaushik recently highlighted that young professionals have the potential to become crorepatis by adopting disciplined financial habits and leveraging the long-term growth of India’s economy with the power of compounding.
In a post shared on X, Kaushik emphasizes that financial discipline is the foundation of wealth accumulation. “If you save at least half of your income consistently, you create the base for substantial wealth over time,” he points out. For someone earning ₹1 lakh per month, saving 50% sets the stage for significant growth without drastically changing lifestyle choices.
Smart Investment Choices
Saving alone is not enough. Investing wisely is the next step. Kaushik recommends putting around 70% of your savings into equities, such as systematic investment plans (SIPs), index funds, or carefully selected quality stocks. Equities, he explains, benefit from India’s growth trajectory and the long-term upward trend of markets. “Investing consistently in equities allows your money to grow exponentially,” Kaushik notes. By focusing on long-term growth rather than short-term market fluctuations, investors can harness the power of compounding.
Consistency Over Decades
Perhaps the most critical factor, according to Kaushik, is time. Staying invested for 20 years or more can turn a monthly SIP of ₹1 lakh into more than ₹10 crore, assuming a reasonable 12% annual return. “This isn’t a fantasy or luck. It’s mathematics working quietly behind the scenes,” he adds.Kaushik stresses that investors do not need to engage in daily trading or attempt to time the market. Instead, the focus should be on believing in India’s long-term economic growth and remaining invested through market cycles.
— Finance_Bareek (@Finance_Bareek)
The Three Habits To Build Wealth
From Kaushik’s insights, three habits emerge for wealth creation before 40:
Save aggressively: Set aside at least 50% of monthly income.
Invest wisely: Allocate the majority of savings to equities for long-term growth.
Be patient and consistent: Maintain investments for decades to leverage compounding.
Those who adopt discipline, strategic investment, and patience now could enjoy a life of financial security and wealth accumulation in the years to come.
Patients with HIV may be able to switch from a multi-tablet regimen to a single-tablet regimen, as a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was found to be equally effective when patients switched from multi-tablet regimens to treat their HIV diagnosis. These results come from the ARTISTRY-1 clinical trial, a phase 3 study.1
Results from the ARTISTRY-1 trial had previously been published earlier in the year, with ARTISTRY-1 showing BIC/LEN was able to keep all but 1 of 103 participants virally suppressed compared with all 25 patients who remained virally suppressed on complex antiretroviral therapy (ART) regimens through 24 weeks.2 These new results update the previous study to evaluate the efficacy through 48 weeks.
Patients on complex regimens are often not able to benefit from single-tablet regimens due to drug-drug interactions, pre-existing resistance, and tolerability, which can leave them with a higher burden of pills to take. Those who participated in ARTISTRY-1 were taking between 2 and 11 pills per day to continue to be virally suppressed. The single-tablet regimen of BIC/LEN aims to address these patients by offering a combination therapy in a single tablet.
“Gilead developed the first single-tablet complete regimen for the treatment of HIV in 2006. Today, innovative single-tablet regimens are still needed to help suit people’s needs, modernizing treatment while helping to sustain viral suppression. By reducing the multi-tablet burden, we hope to improve health outcomes while expanding options,” said Jared Baeten, MD, PhD, senior vice president of clinical development at Gilead Sciences.1
BIC is an integrase strand transfer inhibitor that has a higher barrier to resistance and is only used in combination. LEN has been approved as a method of pre-exposure prophylaxis but has also been used to treat multi-drug-resistant HIV in adults, with its use approved in multiple countries.
Participants of the ARTISTRY-1 trial were aged 18 years or older,2 were virally suppressed for at least 6 months before screening, and were on a stable, complex ART regimen for at least 6 months due to either intolerance, previous viral resistance, or a contraindication to existing single-tablet regimens. Participants were recruited from Australia, Canada, the US, the Dominican Republic, and Puerto Rico.
For the phase 3 part of the study, participants were randomized 2:1 to either BIC/LEN or continued their baseline complex regimen. The study looked for a primary end point of viral suppression of less than 50 copies/mL after 48 weeks, as well as, change in baseline CD4 cell count and the occurrence of treatment-emergent adverse events (TEAEs).
In new results whose details will be revealed at a later date, researchers found that the primary efficacy end point of ARTISTRY-1 was met through 48 weeks and was well-tolerated in the patients.
“These ARTISTRY-1 trial results demonstrate that a combination regimen of bictegravir and lenacapavir maintains viral suppression in people living with HIV who would otherwise have to take a complex multi-tablet regimen. The findings are significant for those people, many of whom have lived with HIV for decades and who have medical comorbidities of aging and thus take many other medications as well,” said Chloe Orkin, MBE, clinical professor of Infection and Inequities at Queen Mary University of London.1
References
1. Gilead’s investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment meets primary endpoint in phase 3 ARTISTRY-1 trial. News release. Gilead. November 13, 2025. Accessed November 14, 2025. https://www.gilead.com/news/news-details/2025/gileads-investigational-single-tablet-regimen-of-bictegravir-and-lenacapavir-for-hiv-1-treatment-meets-primary-endpoint-in-phase-3-artistry-1-trial
2. Mounzer K, Slim J, Ramgopal M, et al. Efficacy and safety of switching to daily bictegravir plus lenacapavir from a complex HIV treatment regimen: a randomized, open-label, multicenter phase 2 study (ARTISTRY-1). Clin Infect Dis. 2025;80(4):881-888. doi:10.1093/cid/ciae522
This November has already provided many exciting developments across the multidisciplinary oncology world. Within the first half of the month alone, the FDA has been busy issuing new approvals and regulatory nods across different breast cancer, leukemia, and gynecologic malignancy populations. Additionally, presentations from the recent 2025 Society for Immunotherapy of Cancer Annual Meeting showcased novel treatment modalities that may show utility across various treatment settings.
CancerNetwork® reported on these latest potential shakeups across oncology. Here are the top 5 takeaways of the week that may influence the future of the field.
#1: FDA Approves Pertuzumab Biosimilar in Breast Cancer Indications
The FDA approved an interchangeable biosimilar formulation of pertuzumab (Perjeta) known as pertuzumab-dpzb (Poherdy), a HER2-neu receptor agonist, in different breast cancer populations.1
Based on various comparisons of parameters related to safety and efficacy, pharmacokinetic data, clinical immunogenicity findings, and supportive clinical data, the agency determined that the biosimilar exhibited sufficient similarity to the reference product. The biosimilar is indicated for use in combination with agents like trastuzumab (Herceptin) across different treatment settings, including adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 treatment or chemotherapy for metastatic disease.
#2: FDA Approves Ziftomenib in R/R NPM1-Mutated Acute Myeloid Leukemia
Another key regulatory decision was the FDA’s approval of ziftomenib (Komzifti) for patients with relapsed/refractory acute myeloid leukemia (AML) harboring NPM1 mutations, based on data from the phase 1b/2 KOMET-001/KO-MEN-001 trial (NCT04067336).2
Topline results from the study showed that 21.4% (95% CI, 14.2%-30.2%) of evaluable patients achieved a complete response (CR) or CR with partial hematologic recovery. Additionally, in 66 patients with red blood cell and/or platelet transfusion dependence at baseline, transfusion independence at any 56-day post-baseline period occurred in 14 (21.2%).
#3: Mecbotamab Vedotin Shows Positive OS Results in Soft Tissue Sarcoma
Data presented at SITC 2025 showed that treatment with mecbotamab vedotin (Mec-V) elicited an overall survival (OS) benefit for those with treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma in a phase 2 trial (NCT03425279).3
Across the overall population, the median OS was 18.4 months (95% CI, 7.2-not evaluable [NE]) with Mec-V alone and 22.9 months (95% CI, 14.2-NE) with Mec-V plus nivolumab (Opdivo). Across different subgroups, the median OS was 19.0 months (95% CI, 7.9-29.9) for patients with leiomyosarcoma, 21.7 months (95% CI, 3.7-NE) for those with liposarcoma, and 21.5 months (95% CI, 5.0-NE) for those with undifferentiated pleomorphic sarcoma.
#4: Novel T-Cell Therapies Yield Decade-Long Remission in Epithelial Cancer
In other presentations shared at SITC 2025, investigational cellular therapies demonstrated various benefits across different epithelial cancer populations.
Findings from one single-center phase 2 trial (NCT05686226) showed that T cell receptor (TCR)–T-cell therapy could produce responses in a small cohort of patients with metastatic HPV-associated cancers.4 Moreover, another presentation on a different phase 2 trial (NCT01585428) highlighted 2 patients with metastatic cervical cancer who remained in CR for at least 10 years following a single infusion of tumor-infiltrating lymphocyte therapy.5
#5: FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer
In another notable decision from the FDA, the agency approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite-stable endometrial carcinoma who may benefit from treatment with pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima).6
Previously, the agency approved pembrolizumab/lenvatinib for this endometrial carcinoma population in July 2021.7 This decision was based on findings from the phase 3 KEYNOTE-775 study (NCT03517449).
References
FDA approves new interchangeable biosimilar to Perjeta. News release. FDA. November 13, 2025. Accessed November 14, 2025. https://tinyurl.com/2vzwt6ej
FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation. News release. FDA. November 13, 2025. Accessed November 14, 2025. https://tinyurl.com/2mcsxzuv
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SEOUL, South Korea — SEOUL, South Korea (AP) — Samsung Electronics and other major South Korean companies on Sunday announced fresh domestic investment plans at a meeting with President Lee Jae Myung, who hopes the moves will counter concerns that the firms would prioritize U.S. investments under a trade deal.
Lee’s meeting with business leaders came days after his government finalized a trade deal with the United States, in which Seoul pledged to invest $350 billion in U.S. industries in exchange for averting the Trump administration’s highest tariffs.
Samsung, a global leader in computer chips, said it will invest 450 trillion won ($310 billion) over the next five years to expand its domestic operations, including building another production line at its Pyeongtaek manufacturing hub to meet surging global semiconductor demands fueled by artificial intelligence.
Samsung said the new line, set to begin operations in 2028, is part of its broader effort to secure additional production capacity in anticipation of rising mid- to long-term demands for memory chips. The company also plans to build AI data centers in the country’s southwest South Jeolla Province and the southeastern city of Gumi to support government efforts to reduce the development gap between the greater Seoul metropolitan area and other regions.
Hyundai Motor Group, South Korea’s largest automaker, said it plans to invest 125 trillion won ($86.3 billion) from 2026 to 2030 to expand domestic research and development and advance new technologies such as AI, robotics and self-driving cars.
SK Group, another semiconductor powerhouse, and shipbuilders Hanwha Ocean and HD Hyundai also announced plans to increase their domestic investments. Both are central to South Korean commitments to boost the U.S. shipbuilding industry, a sector highlighted by President Donald Trump in negotiations with Seoul.
In his meeting with the companies’ chiefs, Lee credited the business sector for helping his government negotiate the trade deal with Washington but urged the companies to maintain strong domestic investments to ease concerns they might cut spending at home to invest more in America. He said his government is exploring various policy steps, including easing regulations, to help create a more favorable business environment for the companies.
SK Chair Chey Tae-won, whose group plans to invest at least 128 trillion won ($88.3 billion) domestically through 2028 with a focus on AI, said the finalization of trade talks with the United States eases uncertainties and paves way for bolder domestic investment.
The two governments on Friday released the details of the trade agreement, including $150 billion in South Korean investments in the U.S. shipbuilding sector and an additional $200 billion in other American industries, which Seoul says will be capped at $20 billion per year to prevent financial instability.
The United States agreed to reduce tariffs on South Korean cars and auto parts from 25% to 15%, and to apply tariffs on South Korean semiconductors on terms “no less favorable” than those granted to comparable competitors in the future.
