Category: 3. Business

WildBrain Ltd. (TSE:WILD) last week reported its latest quarterly results, which makes it a good time for investors to dive in and see if the business is performing in line with expectations. Revenues were in line with expectations, at CA$126m, while statutory losses ballooned to CA$0.15 per share. Earnings are an important time for investors, as they can track a company’s performance, look at what the analysts are forecasting for next year, and see if there’s been a change in sentiment towards the company. Readers will be glad to know we’ve aggregated the latest statutory forecasts to see whether the analysts have changed their mind on WildBrain after the latest results.

We’ve found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.

Taking into account the latest results, the consensus forecast from WildBrain’s four analysts is for revenues of CA$570.7m in 2026. This reflects a reasonable 6.1% improvement in revenue compared to the last 12 months. WildBrain is also expected to turn profitable, with statutory earnings of CA$0.023 per share. Before this latest report, the consensus had been expecting revenues of CA$564.9m and CA$0.01 per share in losses. While there’s been no material change to the revenue estimates, there’s been a pretty clear upgrade to earnings estimates, with the analysts expecting a per-share profit compared to previous expectations of a loss. So it seems like the latest results have led to a significant increase in sentiment for WildBrain.

View our latest analysis for WildBrain

There’s been no major changes to the consensus price target of CA$2.34, suggesting that the improved earnings per share outlook is not enough to have a long-term positive impact on the stock’s valuation. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. The most optimistic WildBrain analyst has a price target of CA$3.00 per share, while the most pessimistic values it at CA$1.60. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await WildBrain shareholders.

Taking a look at the bigger picture now, one of the ways we can understand these forecasts is to see how they compare to both past performance and industry growth estimates. It’s clear from the latest estimates that WildBrain’s rate of growth is expected to accelerate meaningfully, with the forecast 8.2% annualised revenue growth to the end of 2026 noticeably faster than its historical growth of 2.6% p.a. over the past five years. Other similar companies in the industry (with analyst coverage) are also forecast to grow their revenue at 9.9% per year. Factoring in the forecast acceleration in revenue, it’s pretty clear that WildBrain is expected to grow at about the same rate as the wider industry.

The most important thing to take away is that the analysts now expect WildBrain to become profitable next year, compared to previous expectations that it would report a loss. Happily, there were no real changes to revenue forecasts, with the business still expected to grow in line with the overall industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates.

Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have estimates – from multiple WildBrain analysts – going out to 2028, and you can see them free on our platform here.

We don’t want to rain on the parade too much, but we did also find 1 warning sign for WildBrain that you need to be mindful of.

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

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.

Global Ship Lease, Inc. (NYSE:GSL) is about to trade ex-dividend in the next 4 days. The ex-dividend date occurs one day before the record date, which is the day on which shareholders need to be on the company’s books in order to receive a dividend. The ex-dividend date is important as the process of settlement involves a full business day. So if you miss that date, you would not show up on the company’s books on the record date. Meaning, you will need to purchase Global Ship Lease’s shares before the 21st of November to receive the dividend, which will be paid on the 4th of December.

The company’s next dividend payment will be US$0.625 per share, on the back of last year when the company paid a total of US$2.50 to shareholders. Based on the last year’s worth of payments, Global Ship Lease stock has a trailing yield of around 7.2% on the current share price of US$34.51. We love seeing companies pay a dividend, but it’s also important to be sure that laying the golden eggs isn’t going to kill our golden goose! So we need to investigate whether Global Ship Lease can afford its dividend, and if the dividend could grow.

Trump has pledged to “unleash” American oil and gas and these 15 US stocks have developments that are poised to benefit.

Dividends are typically paid from company earnings. If a company pays more in dividends than it earned in profit, then the dividend could be unsustainable. Global Ship Lease has a low and conservative payout ratio of just 19% of its income after tax. Yet cash flows are even more important than profits for assessing a dividend, so we need to see if the company generated enough cash to pay its distribution. Over the last year it paid out 56% of its free cash flow as dividends, within the usual range for most companies.

It’s encouraging to see that the dividend is covered by both profit and cash flow. This generally suggests the dividend is sustainable, as long as earnings don’t drop precipitously.

Check out our latest analysis for Global Ship Lease

Click here to see the company’s payout ratio, plus analyst estimates of its future dividends.

Businesses with strong growth prospects usually make the best dividend payers, because it’s easier to grow dividends when earnings per share are improving. If business enters a downturn and the dividend is cut, the company could see its value fall precipitously. That’s why it’s comforting to see Global Ship Lease’s earnings have been skyrocketing, up 50% per annum for the past five years.

Another key way to measure a company’s dividend prospects is by measuring its historical rate of dividend growth. Global Ship Lease’s dividend payments per share have declined at 2.4% per year on average over the past 10 years, which is uninspiring. It’s unusual to see earnings per share increasing at the same time as dividends per share have been in decline. We’d hope it’s because the company is reinvesting heavily in its business, but it could also suggest business is lumpy.

From a dividend perspective, should investors buy or avoid Global Ship Lease? Earnings per share have grown at a nice rate in recent times and over the last year, Global Ship Lease paid out less than half its earnings and a bit over half its free cash flow. Global Ship Lease looks solid on this analysis overall, and we’d definitely consider investigating it more closely.

On that note, you’ll want to research what risks Global Ship Lease is facing. We’ve identified 2 warning signs with Global Ship Lease (at least 1 which is concerning), and understanding these should be part of your investment process.

Generally, we wouldn’t recommend just buying the first dividend stock you see. Here’s a curated list of interesting stocks that are strong dividend payers.

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

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.

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s agenda since he took office in January. He has taken a number of steps, including striking deals with pharmaceutical companies, to lower the costs of prescription drugs.

Trump has also directed the Food and Drug Administration (FDA) to streamline its regulation process to boost cheaper copycat drugs, such as generic and biosimilar drugs.

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Biosimilars are highly similar versions of biologics, a group of drugs produced through biological processes. One of the most widely used biologic drugs is insulin, which is used to treat diabetes.

Biologics, which make up just 5 percent of prescriptions, account for more than half of the total expenditures on medicines in the US, according to the health data analysis company IQVIA.

The Trump administration said it hopes to make these medications more affordable, partly by increasing access to biosimilars.

So what are biologics and biosimilars, and will the administration’s proposals help drive down their costs?

What are biologics?

Biologics is short for biological medications or products. It’s a broad category of products that include vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms, such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders.

Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Biosimilars Council at the Association for Accessible Medicines, an industry group that advocates on behalf of biosimilar manufacturers.

The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists to expedite COVID-19 vaccines, for example.

What are biosimilars?

As the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and sold after the original biologic has lost its patent exclusivity, Keeton said. Biosimilars for Humira, a drug used by people with rheumatoid arthritis, include Cyltezo, Amjevita and Idacio.

“They still work the same way clinically, but they’re not exactly the same,” Keeton said.

That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their components are derived from live organisms.

“Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,” Chen said.

The FDA evaluates proposed biosimilar products against the original biologic to determine whether the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic. To be approved, biosimilar manufacturers must show patients using their products don’t have new or worsening side effects compared with patients using the original biologic.

FDA approval for biosimilars often takes five to six years, Keeton said.

Biosimilars increase market competition, incentivising brand name drug manufacturers to lower their prices.

How much do biologics and biosimilars usually cost?

They’re pricey, and exact costs vary.

One 2018 study found that biologics and biosimilars can cost a US patient $10,000 to $30,000 each year on average.

Humira is more. It was listed at $6,922 for a month’s supply in early November. The Humira biosimilar Cyltezo advertises for 5 percent off Humira’s cost. The makers of Cyltezo also offer a non-brand name option for people who pay cash at pharmacies while using the GoodRx app at a price of $550.

The actual amount insured patients pay also depends on their plan and their insurer’s negotiated rates.

Biosimilar prices typically run 15 percent to 35 percent lower than their brand name biologic counterparts, one 2024 study found. The FDA found biologics produce a more dramatic cost savings of 50 percent on average.

Why are these medications so expensive?

Biologics and biosimilars are difficult to develop and produce, which adds to their expense.

Making a standard over-the-counter medication such as aspirin requires five ingredients. Making insulin, a biologic, requires genetic modifications to living organisms.

These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.

To put this in perspective, there were 226 marketed biologics in the US as of July, and the FDA had approved 76 biosimilars such as insulin. When it comes to non-biologic medications, the FDA has approved more than 32,000 generic drugs. That’s more than the number of approved brand name drugs.

Can biosimilars be used in place of the original, FDA-approved biologics?

Yes. All biosimilars must meet FDA requirements and must be highly similar and have no clinically meaningful differences from their existing FDA-approved biologic counterpart.

So how does the Trump administration hope to change the FDA approval process for biosimilars?

Under its draft guidance, the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart.

Currently, a manufacturer requesting a biosimilar licence has to provide clinical study data proving its product’s similarity. The FDA’s new proposal would no longer require drug developers to conduct these comparative clinical trials.

Manufacturers would still be required to test proposed biosimilars. Other data – including comparative analysis, immune response data and human study data showing how the drug moves through the body – could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.

Why does the FDA want to change the biosimilar approval process?

Ultimately, the agency said it aims to incentivise drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.

Saving that time might increase the number of biosimilar alternatives.

It would almost certainly lower the front-end development costs for drugmakers, Chen said.

Will that change lower the costs of these medications for patients who need them?

Regulatory changes alone may not significantly drive down prices for many Americans.

Several non-brand name options need to be available to produce significant price drops, according to a US Department of Health and Human Services report.

But prices could remain the same even with more options.

A 2024 study in the JAMA Health Forum, a health policy journal, found that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics.

That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others to manage prescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.

Are there any other obstacles to getting more biosimilars on the market?

Yes, another key hurdle remains: Name brand biologic manufacturers often hold many patents and file lawsuits blocking approved biosimilars from being commercially marketed.

A 2018 study conducted by Chen found that of 12 FDA-approved biosimilar products, five were commercially available as of October 2018. Six others were unavailable because of patent disputes.

PolitiFact researcher Caryn Baird contributed to this report.

Scott Bessent, the US treasury secretary, returned from South Carolina last week brandishing a small piece of metal, proclaiming that it was the first rare-earth magnet made in the US in a quarter of a century.

It was, he indicated to Fox Business, proof that the US is ending “China’s chokehold on our supply chain”. Thanks to the South Carolina company eVAC’s new rare-earth mineral processing center, Bessent added: “We’re finally becoming independent again.”

Breaking China’s processing and manufacturing dominance in these materials, essential for some semiconductors, batteries and armaments, is a top priority for the Trump administration that has made a bet, via tariffs and other economic tools, that it can return the industry to US shores.

Those tariffs led China to restrict rare-earth exports to the US and pushed Donald Trump to sign deals with Australia, Malaysia, Cambodia and Japan.

The US and China have now brokered a trade truce on rare earths but China, with approximately 70% of global mining and over 90% of global processing capacity, has a head start that Trump will struggle to erode.

There’s no easy fix for the US to reset its dependence on Chinese production of minerals critical to national security, semiconductor production, and the transfer of energy production from fossil fuels to wind and solar. The US imported 80% of the rare earths it used in 2024, according to the US Geological Survey.

For some rare-earth minerals such as dysprosium, used in chip production, and samarium, essential to military applications, Chinese refinement dominance rises to 99%. Dysprosium and terbium are used in magnets essential for electric engines in electric vehicles and generators in wind turbines, along with uses in cellphones, high-intensity lighting and nuclear reactors.

“These materials are used in electric motors for EV cars but also in guidance systems that have obvious applications for the defense department,” says Adam Webb, head of energy raw materials at Benchmark Mineral Intelligence. “Anything that has a decent magnet in it uses rare earths.”

Trump’s efforts to reduce the US’s dependence on Chinese production on rare-earth minerals could take years. “‘Rare earths’ is somewhat of a misnomer because they’re not that uncommon in terms of abundance in the earth’s crust,” Webb says, but many deposits, including in Ukraine, where Trump made a deal earlier this year, are only in the early stages of extraction.

“It’s not that there’s a shortage per se, it’s that China can limit how much is exported,” Webb said, adding that getting export licenses from China can be a lengthy, difficult process.

Greenland, another focus of Trump’s attention, and Brazil, are two other countries where there are significant rare-earth deposits. In the continental US, there are deposits in California, Wyoming and Missouri, with the largest operational mine operating at Mountain Pass, California, about 60 miles from Las Vegas.

In July, the Pentagon became the largest shareholder in MP Materials, the operator of the California mine, with plans to open a new “mine-to-magnet” plant, called 10X, to make magnets crucial in F-35 fighter jets, drones and submarines, according to the department.

In North America, measured and indicated resources of rare earths were estimated to include 3.6m tons in the US and more than 14m tons in Canada, according to the geological survey data – far less than the 44m tons estimated in China.

Mirroring direct investment and stakes in the steel industry and US chipmaker Intel, the interior department said it was prepared to make direct investments in critical mineral companies.

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“You’re competing against state capital because China is picking these strategically as areas that they want to invest in,” Doug Burgum, the US secretary of the interior, said during a speech at the Hamm Institute for American Energy in April.

Burgum floated that the US could utilize a sovereign wealth fund to speed production. “Why wouldn’t the wealthiest country in the world have the biggest sovereign wealth fund?” he asked.

US efforts to support domestic production have floundered in the past when China lowered prices, rendering unsupported rare-earth development uneconomic against China’s lower cost of production and long-term strategic outlook.

Five years ago, Simon Moores, managing director of Benchmark Mineral Intelligence, testified before the US Senate committee on energy and natural resources that “those who invest in battery capacity and supply chains today are likely to dominate this industry for generations to come. It is not too late for the US but action is needed now.”

Five years on, a scramble to assemble trading alliances around rare earths is accelerating.

“In about a year from now, we’ll have so much critical mineral and rare earths that you won’t know what to do with them,” Trump told reporters. That came eight months after Trump demanded $500bn of Ukraine’s minerals to compensate the US for the military aid. In September, the government of Pakistan signed a $500m deal with the American company US Strategic Metals, giving it access to minerals such as antimony and copper.

But can the US make up its shortfall and loosen China’s hold on rare-earth supply chains? “The US has taken really significant steps already,” Webb says. The US, he adds, cannot be “self-reliant in the short term because it takes time to bring a mine online and build refining capacity.”

• SAR 600M investment: Agreement represents phased investment of SAR 600 million to establish a localized industrial gases production supply chain in Oxagon and across NEOM
• Strategic infrastructure readiness: Production and distribution facility will enable tenants to commence seamless production, signaling a move into the activation phase of Oxagon’s industrial development

NEOM, Kingdom of Saudi Arabia – 16 November 2025 – Oxagon, the reimagined industrial city of NEOM, has announced the signing of a land lease agreement between NEOM and Abdullah Hashim Industrial Gases & Equipment Co. Ltd (AHG) – a leading provider of industrial gases to industries across Saudi Arabia.

As part of a planned SAR 600 million investment, AHG will develop in multiple phases a state-of-the-art industrial gases production and distribution facility in Oxagon’s Industrial Quarter, the city’s dedicated industrial district. With groundbreaking scheduled for February 2026, the first phase will include essential industrial gases infrastructure, offices, warehousing and distribution capabilities. Operations are also due to commence in late 2026 with subsequent phases expected to start in 2028.

This strategic partnership signals Oxagon’s readiness as an industrial city, with the production and distribution of industrial gases paving the way for tenants to ramp up development and begin production from 2026 onwards.

“Our partnership with AHG exemplifies Oxagon’s readiness to welcome world-class tenants and accelerate the Kingdom’s transition to a diversified, future-ready economy,” said Vishal Wanchoo, CEO of Oxagon. “Leveraging AHG’s industrial gases expertise, we are developing a streamlined local supply chain that meets the demands of modern industry and supports the transition to sustainable energy solutions, enabling cleaner manufacturing practices.”

“We are excited to be part of Oxagon’s development plan and are keen to play our role in supporting the industrial gases requirements of international and local investors with cost competitive, high reliability products and services,” said Khalid Abdullah Hashim CEO of the AHG Group Companies. “The land lease agreement, followed by our investment plan in low carbon industrial gases production facilities, demonstrates our commitment to supporting the clean industrial transformation taking place in Oxagon.”

The demand for industrial gases in Oxagon is anticipated to grow as the region continues to attract industries across manufacturing, transportation and beyond. AHG’s new facility will play a vital role in localized production and distribution, reducing reliance on long-distance imports, minimizing supply chain disruptions and reducing carbon dioxide (CO₂) emissions from transport. Additionally, it will enhance cost competitiveness for tenants by providing them with more affordable and reliable access to essential industrial gases. This is a step forward in addressing some of the broader environmental impacts of manufacturing, including value chain (scope 3) emissions.

As part of its phased development plan, AHG plans to produce green oxygen, nitrogen, argon and hydrogen, further supporting Saudi Arabia’s broader renewable energy transition goals. This plan will offer a strategic advantage for global manufacturers seeking to lower operating costs while meeting environmental targets.

A long-term partner of NEOM’s development, AHG currently supports the broader construction underway in northwest Saudi Arabia by supplying industrial gases and equipment to contractors. This new facility will strengthen those efforts, while also enabling tenants in Oxagon to advance infrastructure projects more efficiently. In line with Saudi Vision 2030, development of the facility will also stimulate GDP growth through the creation of specialized roles in the industrial gases sector, equipping local talent with advanced skills and expertise.

Several therapeutic advances have reshaped the treatment landscape in small cell lung cancer (SCLC) over the past year, signaling a long-anticipated shift away from historically stagnant standards of care (SOC) and toward a more dynamic, targeted paradigm, according to Charles M. Rudin, MD, PhD, who added that the future of drug development for this disease has never been brighter.¹

In a presentation delivered during the 20th Annual New York Lung Cancers Symposium®, Rudin highlighted how new drug classes, such as antibody-drug conjugates (ADCs) and T-cell engagers, and cell surface–directed strategies are driving this evolution, demonstrating efficacy that would have been difficult to envision a decade ago.

“2025 has been a real banner year for SCLC research, with some promising data emerging,” Rudin, who is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center in New York, stated. “ADCs have the potential to displace platinum/etoposide in the first-line setting… [which] we’ve been giving for decades together with immune checkpoint blockade…and given the data [we’ve seen] with tarlatamab [Imdelltra], a T-cell engager can be added here, potentially changing the first-line SOC.”

Rudin also serves as deputy director of the Cancer Center, co-director of the Druckenmiller Center for Lung Cancer Research, and the Sylvia Hassenfeld Chair in Lung Cancer Research.

Rudin Spotlights Key Advances in the Small Cell Lung Cancer

• SCLC treatment is rapidly evolving, with ADCs and T-cell engagers delivering efficacy once thought unattainable and signaling a shift away from long-standing standards.

• Tarlatamab is emerging as a new standard, demonstrating strong survival benefits in second-line ES-SCLC and promising activity in frontline maintenance combinations.

• Next-generation ADCs like I-DXd and ABBV-706 show high response rates, positioning them as potential future challengers to platinum/etoposide in the first-line setting.

How Has Checkpoint Inhibition Changed the SOC in SCLC?

Checkpoint inhibitors have now become embedded in the management of extensive-stage SCLC (ES-SCLC), but their impact is complex, Rudin explained. In limited-stage SCLC, durvalumab (Imfinzi) has recently shifted a decades-long paradigm dominated by concurrent platinum-based chemoradiotherapy alone.

Data from the phase 3 ADRIATIC trial (NCT03703297), which supported the December 2024 FDA approval of durvalumab in LS-SCLC, showed a statistically significant improvement in overall survival (OS) with durvalumab (n = 264) vs placebo (n = 266), at a median of 55.9 months (95% CI, 37.3-not reached [NR]) and 33.4 months (95% CI, 25.5-39.9), respectively (HR, 0.73; 95% CI, 0.57-0.93; P = .0104).² The median progression-free survival (PFS) was similarly improved with durvalumab (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).

“On the one hand, we do see real, long-term, transformative benefit [with checkpoint inhibitors] in a small subset of patients,” Rudin said about this “yin and yang” of immune checkpoint blockade in SCLC.¹ “We have patients with metastatic SCLC who are cured with immunotherapy. That is good for those patients, but it leaves out [approximately] 85% of the patients who [derive] no benefit from the addition of immune checkpoint blockade.”

Ultimately, checkpoint blockade has changed the SOC in SCLC, but only for a minority of patients, underscoring the need for additional strategies to broaden the benefit of immunotherapy, Rubin asserted.

Could Adding Chemotherapy to Maintenance Immunotherapy Improve Outcomes?

One emerging strategy for bolstering immunotherapy responses in SCLC is to intensify the maintenance phase by layering cytotoxic agents onto PD-L1 inhibition. The phase 3 IMforte trial (NCT05091567) explored the addition of lurbinectedin (Zepzelca) to atezolizumab (Tecentriq) vs atezolizumab alone as maintenance therapy in ES-SCLC after induction therapy.³

Primary results presented at the 2025 ASCO Annual Meeting showed that the combination (n = 242) significantly improved PFS vs atezolizumab alone (n = 241; HR, 0.54; 95% CI, 0.43-0.67; 2-sided P < .0001). The median PFS by independent review facility assessment was 5.4 months (95% CI, 4.2-5.8) with lurbinectedin plus atezolizumab vs 2.1 months (95% CI, 1.6-2.7) with atezolizumab monotherapy. The 12-month PFS rates were 20.5% vs 12.0%, respectively. Furthermore, the median OS was 13.2 months (95% CI, 11.9-16.4) with the combination vs 10.6 months (95% CI, 9.5-12.2) with atezolizumab alone (HR, 0.73; 95% CI, 0.57-0.95; 2-sided P = .0174). The 12-month OS rates were 56.3% vs 44.1%, respectively.

“This is a win. It’s a good drug and it works,” Rudin said. “However, I’m not sure this is as practice changing as I would like. One criticism that has been raised about this study is that only a minority of these patients on the control arm ever [received] lurbinectedin.”

Rubin also pointed out the clinical trade-off of introducing a cytotoxic agent at a time when patients might otherwise enjoy a chemotherapy break. In his view, a key goal of maintenance strategies should be to prolong survival outcomes, and he did not see compelling evidence from IMforte that the tail of the Kaplan-Meier curve was substantially altered.

“We need more follow-up from this trial, and we still need to work on better maintenance strategies.”

How Are T-Cell Engagers Reshaping Second-Line and Maintenance Therapy?

T-cell engagers represent one of the most promising new modalities in SCLC, particularly because they bypass some of the limitations of antigen presentation that constrain checkpoint blockade, Rubin explained. Tarlatamab (Imdelltra) is currently “the hot drug in this field,” although several other T-cell engagers are demonstrating comparable activity.

Tarlatamab in the Second-Line Setting

Rudin pointed to pivotal data from the phase 3 DeLLphi-304 trial (NCT05740566), which compared tarlatamab with chemotherapy in patients with previously treated ES-SCLC. Data published in the New England Journal of Medicine and presented at the 2025 ESMO Congress showed that the median OS was 13.6 months (95% CI, 11.1-NR) with tarlatamab (n = 254) vs 8.3 months (95% CI, 7.0-10.2) with chemotherapy (n = 255; HR, 0.60; 95% CI, 0.47-0.77; P < .001).⁵ In those with platinum-resistant disease, defined as a chemotherapy-free interval (CFI) of less than 90 days, the median OS with tarlatamab was 10.9 months vs 6.4 months with chemotherapy (HR, 0.60; 95% CI, 0.43-0.84).⁶ In those with platinum-sensitive disease, defined as a CFI of 90 days or longer, the median OS in the tarlatamab and chemotherapy arms was 17.1 months and 10.6 months, respectively (HR, 0.65; 95% CI, 0.45-0.93).

Importantly, prior exposure to PD-L1 blockade did not appear to negatively affect benefit with tarlatamab. In patients who had received prior anti–PD-L1 agents, the median OS was 14.1 months with tarlatamab vs 8.3 months with chemotherapy (HR, 0.61; 95% CI, 0.45-0.82). In those without prior anti–PD-L1 therapy, median OS was 13.6 vs 8.3 months, respectively (HR, 0.65; 95% CI, 0.42-1.03).

“I would argue that this is, for most patients, the new SOC in this country,” Rudin said, adding that the magnitude and consistency of benefit make tarlatamab compelling in the second line.

Tarlatamab in Frontline Maintenance Therapy

Rudin also highlighted emerging data signaling the potential efficacy of tarlatamab as part of frontline maintenance regimens. Extended follow-up from the phase 1b DeLLphi-303 trial (NCT05361395), presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer and published in Lancet Oncology, showed that tarlatamab plus anti–PD-L1 therapy (n = 88) led to a median OS of 25.3 months (95% CI, 20.3-not evaluable [NE]) and a median PFS of 5.6 months (95% CI, 3.5-9.0).⁷ The disease control rate (DCR) was 60% and the median duration of disease control was 14.6 months (95% CI, 7.2-18.4). The objective response rate (ORR) was 24% and comprised 2 complete responses and 19 partial responses; the median duration of response (DOR) was 16.6 months (95% CI, 7.1-NE).

Additional cohort data from DeLLphi-303 presented at the 2025 ESMO Congress explored tarlatamab in combination with frontline chemoimmunotherapy (n = 96) in ES-SCLC.⁸ At a median follow-up of 13.8 months (95% CI, 12.5-15.0), the ORR was 71% (95% CI, 61%-80%), with a complete response (CR) rate of 5% and a partial response rate of 66%; 11% of patients had stable disease, 8% had progressive disease, and responses were not evaluable in 9%. The median DOR was 11.0 months (95% CI, 8.5-NE), the DCR was 82% (95% CI, 73%-89%), and the median duration of disease control was 10.7 months (95% CI, 7.7-18.8).

“These are really striking results,” Rudin remarked. “We have not seen these sorts of survival curves for patients with recurrent SCLC. Even in the maintenance setting, you could argue the start of these curves should be lower… but this looks really good. [These are] early data, but this is a 96-patient trial—that is not to be [discounted].”

Could ADCs Eventually Displace Platinum/Etoposide in the First-Line Setting?

ADCs are another major component of what Rudin described as a new wave of drug development in SCLC, specifically targeting cell surface proteins rather than driver oncogenes. He focused on 2 agents that he believes may ultimately challenge platinum/etoposide in the frontline setting: the B7-H3–directed ADC ifinatamab deruxtecan (I-DXd) and a seizure-related homolog protein 6 (SEZ6)–targeting ADC ABBV-706.¹

Ifinatamab Deruxtecan

In the phase 2 IDeate-Lung01 trial (NCT05280470), patients who received I-DXd at the 12-mg/kg dose (n = 137) achieved a confirmed ORR of 48.2% (95% CI, 39.6%-56.9%), which included a 2.2% CR rate. The DCR was 87.6% (95% CI, 80.9%-92.6%).⁹

The median PFS was 4.9 months (95% CI, 4.2-5.5), with 3-, 6-, and 9-month PFS rates of 68.0% (95% CI, 59.4%-75.2%), 35.3% (95% CI, 27.3%-43.4%), and 19.3% (95% CI, 12.9%-26.5%), respectively. The median OS was 10.3 months (95% CI, 9.1-13.3), and the 3-, 6-, and 9-month OS rates were 89.1% (95% CI, 82.5%-93.2%), 77.4% (95% CI, 69.4%-83.5%), and 59.1% (95% CI, 50.4%-66.8%), respectively.

In August 2025, ifinatamab deruxtecan was granted breakthrough therapy designation from the FDA for patients with ES-SCLC whose disease progressed on or after platinum-based chemotherapy.¹⁰

“We have not seen this sort of activity for a cytotoxic in SCLC in a long time,” Rudin commented. “This is delivering the cytotoxic to the tumor, and we are seeing response rates in the second-line setting of over 50%.”

ABBV-706

Updated data from the dose-optimization portion of a phase 1 trial (NCT05599984), presented at the IASLC 2025 World Conference on Lung Cancer, showed that ABBV-706 induced a confirmed ORR (cORR) of 58% in the total population (n = 80).¹¹

Responses were observed across key clinical subgroups, including patients with platinum-refractory or -resistant disease and those with brain metastases. Among patients who had received 2 prior lines of therapy (n = 30) or at least 3 prior lines (n = 50), the confirmed ORRs (cORR) were 77% and 46%, respectively. For patients with a CFI of at least 90 days (n = 30), less than 90 days (n = 41), and less than 30 days (n = 19), cORRs were 57%, 59%, and 53%, respectively. Among patients with (n = 28) and without (n = 36) brain metastases at baseline, cORRs were 57% and 69%, respectively. Notably, SEZ6 expression levels were similar between responders and nonresponders.

“These are also nice-looking data, with a large majority of patients benefiting,” Rudin added. “[Both of these ADCs] have [produced] high response rates and have the potential to displace platinum-etoposide as a first-line therapy. We will see if that happens.”

What Do All These Agents Have in Common?

Across checkpoint inhibitors, T-cell engagers, and ADCs, Rudin pointed to a unifying theme: All the most promising agents in SCLC are targeting the cell surface rather than oncogenic drivers.¹ “This is a very different strategy than what we have seen for, say, lung adenocarcinoma, where we made such progress by defining driver mutations and specifically subsetting disease and going after these driver mutations one by one,” he explained. “That does not work in SCLC.”

SCLC is characterized by loss of key tumor suppressor genes rather than discrete kinase drivers, making traditional targeted approaches unsuccessful. Accordingly, unconventional targets such as LSD1and EZH2, as well as a range of cell surface proteins, are now under investigation.

“It is a different, orthogonal strategy, but it is one that is increasingly exciting for this disease,” Rudin concluded.

Looking ahead, Rudin envisions a treatment paradigm in which frontline chemoimmunotherapy is followed by more effective maintenance combinations, second-line T-cell engagers become new standards, and ADCs like I-DXd and ABBV-706 potentially move into the first-line setting, transforming what has been one of the most therapeutically constrained areas in lung cancer.

References

1. Rudin CN. New drugs for small cell lung cancer. Presented at: 20th Annual New York Lung Cancers Symposium; November 15, 2025; New York, New York. Accessed November 15, 2025.
2. FDA approves durvalumab for limited-stage small cell lung cancer. News Release. December 4, 2024. Accessed November 15, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer
3. Paz-Ares L, Borghaei H, Liu SV, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): primary results of the phase 3 IMforte trial. J Clin Oncol. 2025;43(suppl 16):8006. doi:10.1200/JCO.2025.43.16_suppl.8006
4. Rudin C, Mountzios G, Sun L, et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): primary analysis of Ph3 DeLLphi-304. J Clin Oncol. 2025;43(suppl 17):LBA8008. doi:10.1200/JCO.2025.43.17_suppl.LBA8008
5. Mountzios G, Sun L, Cho BC, et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med. Published online June 2, 2025. doi:10.1056/NEJMoa2502099
6. Rocha P, Sun L, Cho BC, et al. Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase 3 DeLLphi-304 trial. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA101.
7. Paulson KG, Lau SCM, Ahn M-J, et al. Safety and survival update of tarlatamab and anti-PD-L1 as first-line maintenance after chemo-immunotherapy for extensive-stage small cell lung cancer: DeLLphi-303 ph1b trial. Presented at: International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract OA13.01.
8. Wermke M, Lau SCM, Moskovitz M, et al. Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study. Ann Oncol.2025; 36 (suppl 2):S1365: doi:10.1016/j.annonc.2025.08.3368 External Link
9. Rudin CM, Johnson ML, Paz-Ares L, et al. Ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer: primary analysis of the phase II IDeate-Lung01 trial. J Clin Oncol. Published online October 14, 2025. doi:10.1200/JCO-25-02142
10. Ifinatamab deruxtecan granted breakthrough therapy designation by U.S. FDA for patients with pretreated extensive-stage small cell lung cancer. News release. Merck. August 18, 2025. Accessed November 15, 2025. https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/
11. Byers LA, Cho BC, Cooper AJ, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein 6–targeting antibody-drug conjugate, in R/R SCLC. Presented at: International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract OA06.04.

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JERUSALEM, Nov 16 (Reuters) – Israel’s economy grew an annualised 12.4% in the third quarter, the Central Bureau of Statistics said on Sunday, in data that showed a bounceback from a weak second quarter that was hit more by the Gaza war.

The gain in gross domestic product in the July-September period topped a Reuters consensus of an 8% expansion and was led by broad-based gains led by consumer spending, exports and investment.

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GDP in the second quarter was revised to a 4.3% contraction from a prior 3.9%.

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