Category: 3. Business

Equifax (EFX) has rolled out its new Ignite AI Advisor platform, which brings lender-focused analytics and generative AI capabilities to the forefront. This launch comes at a time of industry shifts, including changes to credit scoring access that could affect future revenue.

See our latest analysis for Equifax.

Despite Equifax’s ongoing push into AI-powered products for lenders, the company’s recent developments arrive amid shifting industry dynamics and competitive pressures. Over the past year, shareholders have faced a total return decline of nearly 19%, while the share price has fallen almost 10% year-to-date. This serves as a reminder that sentiment has faded even as management pursues new growth avenues. Meanwhile, three- and five-year total shareholder returns remain solidly positive, suggesting longer-term investors have still come out ahead.

If you’re interested in uncovering what else is gaining momentum beyond the headlines, this is a great time to expand your search and discover fast growing stocks with high insider ownership

Given recent innovations and ongoing industry disruptions, the key question for investors is whether Equifax’s current valuation still leaves room for upside, or if the market is already pricing in the company’s growth prospects.

Equifax’s most widely followed fair value narrative puts the company’s worth at $277.70 per share, notably above the last close price of $226.91. This suggests that, according to current consensus, the market is not yet pricing in all the drivers that underpin the long-term outlook.

“Accelerating customer adoption of new multi-data product solutions (e.g., TWN indicator, Single Data Fabric, EFX.AI) and continued high NPI (New Product Introduction) rates are expanding Equifax’s value proposition and positioning the company to capture incremental market share and drive sustained organic revenue growth above historical levels. Structural expansion of government verification requirements (e.g., semiannual redeterminations, added work requirements, improper payment focus) and a rising TAM for eligibility verification services are set to benefit long-term revenue growth and reduce business cyclicality as Equifax’s solutions become more critical to federal and state programs.”

Read the complete narrative.

Curious what’s behind that premium price? The secret sauce is in the projected pace of revenue expansion, ambitious margin targets, and a future earnings multiple seldom seen in the industry. Want to see which bullish financial levers drive this fair value? Click through for the complete playbook; your next big insight could be one number away.

Result: Fair Value of $277.70 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, ongoing legal costs and fresh regulatory uncertainty may cloud the earnings outlook and challenge Equifax’s momentum over the next few years.

Find out about the key risks to this Equifax narrative.

While the analyst consensus sees Equifax as undervalued based on future earnings growth and price targets, price-based metrics tell a different story. The shares trade at about 43.9 times earnings, which is much higher than both its industry peers and the market’s fair ratio of 34.8. This premium suggests investors are already paying up for expected growth, increasing the risk if those expectations fall short. Could this gap be a warning sign or an opportunity in disguise?

See what the numbers say about this price — find out in our valuation breakdown.

If you think there’s another side to this story, or want to dive deeper yourself, building your own data-driven narrative takes just a few minutes. Do it your way

A great starting point for your Equifax research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.

Smart investors know opportunities go far beyond just one company, so don’t limit yourself. Explore unique market trends and sharpen your edge today.

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 EFX.

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

Tarlatamab-dlle (Imdelltra) demonstrated a significant overall survival (OS) advantage over standard chemotherapy in patients with small cell lung cancer (SCLC), irrespective of chemotherapy-free interval (CFI) duration or prior anti–PD-(L)1 therapy, according to results from the phase 3 DeLLphi-304 trial (NCT05740566) presented at the 2025 ESMO Congress.

The median OS was 10.9 months in the tarlatamab arm vs 6.4 months in the chemotherapy arm among patients with a CFI of less than 90 days (HR, 0.60; 95% CI, 0.43-0.84). The 12-month OS rates in this population were 40% vs 24% with tarlatamab and chemotherapy, respectively.

Among patients with a CFI of 90 days or longer, the median OS was 17.1 months compared with 10.6 months in each arm, with respective 12-month OS rates of 64% and 48% (HR, 0.65; 95% CI, 0.45-0.93). Regarding patients with disease progression within 2 weeks of their most recent platinum-containing treatment, the Kaplan-Meier estimated 6-month OS rates were 55% with tarlatamab and 35% with chemotherapy.

Among patients with prior receipt of anti–PD-(L)1 agents, the median OS was 14.1 months in the tarlatamab arm and 8.3 months in the chemotherapy arm; the respective 12-month OS rates were 53% vs 36% (HR, 0.61; 95% CI, 0.45-0.82). In the group of patients without prior anti–PD-(L)1 therapy, the median OS was 13.6 months vs 8.3 months, and the 12-month OS rates were 53% vs 40% (HR, 0.65; 95% CI, 0.42-1.03). Overall, data showed that prior exposure to anti–PD-(L)1 agents did not affect OS benefits with tarlatamab vs chemotherapy.

“In the second line, standard chemotherapies have demonstrated modest survival benefits, especially [in] those patients with platinum-resistant disease, [who] often have a poor prognosis. DeLLphi-304 is the first randomized phase 3 trial to demonstrate superior OS with tarlatamab compared with standard chemotherapy. Importantly, this survival benefit extended to patients with platinum-resistant disease,” presenting author Pedro F. Simoes da Rocha, MD, PhD, of Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology in Barcelona, Spain, stated in the presentation.¹ “These findings reinforce the use of tarlatamab as a standard of care in second-line SCLC, including those patients with worse prognosis, such as [those] with platinum-resistant disease.”

In the randomized DeLLphi-304 trial, 509 patients were assigned 1:1 to receive tarlatamab (n = 254) or investigator’s choice of chemotherapy (n = 255), which included options of topotecan (n = 185), lurbinectedin (Zepzelca; n = 47), and amrubicin (n = 23). Investigators stratified patients by prior receipt of anti–PD-(L)1 agents, CFI interval, presence of brain metastases, and intended chemotherapy.

The trial’s primary end point was OS. Secondary end points included progression-free survival, patient-reported outcomes, objective response rate, and safety.

Patients with histologically or cytologically confirmed SCLC, disease progression following frontline platinum-based chemotherapy with or without anti–PD-(L)1 therapy, and an ECOG performance status of 0 or 1 were eligible for enrollment on the trial. Those with asymptomatic, treated, or untreated brain metastases were able to enroll.

In the tarlatamab and chemotherapy arms, respectively, 43% and 45% of patients had a CFI of less than 90 days, and 57% and 55% had a CFI of 90 days or longer. Additionally, 71% of patients in both arms had prior receipt of anti–PD-(L)1 therapy, while 29% from both arms did not. Investigators noted that subgroup baseline characteristics appeared to be balanced between treatment arms.

Across the different CFI and anti–PD-(L)1 subgroups, rates of grade 3 or higher treatment-related adverse effects (AEs) ranged from 24% to 30% in the tarlatamab arm and 58% to 69% in the chemotherapy arm. Any-grade events of cytokine release syndrome (CRS) occurred in 51% to 59% of patients who received tarlatamab across various subgroups, and subgroup status did not impact the risk of CRS.

Previously, the FDA granted accelerated approval to tarlatamab as a treatment for patients with extensive-stage SCLC following progression on prior platinum-based chemotherapy in May 2024.² Supporting data for this indication came from the phase 2 DELLphi-301 trial (NCT05060016).

References

1. 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 the European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. LBA101.
2. FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer. News release. FDA. May 16, 2024. Accessed October 18, 2024. https://tinyurl.com/48k34rw5

The combination of pembrolizumab (Keytruda) plus weekly paclitaxel with or without bevacizumab (Avastin) generated a statistically significant progression-free survival (PFS) benefit vs placebo plus paclitaxel with or without bevacizumab regardless of PD-L1 status, as well as an overall survival (OS) benefit, in patients with recurrent, PD-L1–expressing platinum-resistant ovarian cancer (PROC), according to data from the phase 3 ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189) presented at the 2025 ESMO Congress.

The analysis was broken down between the population of patients with a combined positive score (CPS) of 1 or higher and the intention-to-treat population. Furthermore, data were broken down between interim analysis 1 (IA1), which had a data cutoff date of April 3, 2024, and interim analysis 2 (IA2), which had a data cutoff date of May 5, 2025.

The CPS of 1 or Higher Population

At IA1, the median PFS was 8.3 months (95% CI, 7.0-9.4) in the pembrolizumab arm compared with 7.2 months (95% CI, 6.2-8.1) in the placebo arm, with 12-month PFS rates of 35.2% (95% CI, 28.8%-41.7%) vs 22.6% (95% CI, 17.0%-28.7%), respectively (HR, 0.72; 95% CI, 0.58-0.89; P = .0014).

At IA2, the median PFS was 8.3 months in the pembrolizumab arm compared with 7.2 months in the placebo arm (HR, 0.75; 95% CI, 0.61-0.91); the 12-month PFS rates were 35.9% vs 23.9%, respectively, and the 18-month rates were 18.7% vs 10.5%.

The median OS was 18.2 months (95% CI, 15.3-21.0) in the pembrolizumab arm compared with 14.0 months (95% CI, 12.5-16.1) in the placebo arm, with 12-month OS rates of 69.1% vs 59.3%, and 18-month OS rates of 51.5% vs 38.9%, respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053).

The objective response rate (ORR) was 53.0% (95% CI, 45.8%-60.0%), with a complete response (CR) rate of 9.9% and a partial response (PR) rate of 43.1%, in the pembrolizumab arm; in the placebo arm, the ORR was 46.6% (95% CI, 39.6%-53.7%), with a CR rate of 7.8% and a PR rate of 38.7%. The 12- and 18-month duration of response (DOR) rates in the pembrolizumab arm were 46.7% and 28.4% compared with 29.6% and 16.4% in the placebo arm.

The ITT Population

At IA1, the median PFS was 8.3 months (95% CI, 7.2-8.6) with pembrolizumab compared with 6.4 months (95% CI, 6.2-8.1) with placebo, with 12-month PFS rates of 33.1% (95% CI, 27.7%-38.5%) and 21.3% (95% CI, 16.6%-26.4%), respectively (HR, 0.70; 95% CI, 0.58-0.84; P <.0001).

At IA2, the median PFS was 8.3 months vs 6.4 months, respectively (HR, 0.73; 95% CI, 0.62-0.86); the 12-month PFS rates were 33.7% vs 22.5%, and the 18-month PFS rates were 17.3% vs 9.0%.

The ORR was 50.4% (95% CI, 44.3%-56.4%), with a CR rate of 8.3% and a PR rate of 42.0%, in the pembrolizumab arm; in the placebo arm, the ORR was 40.8% (95% CI, 35.0%-46.8%), with a CR rate of 6.0% and a PR rate of 34.8%.Furthermore, the 12- and 18-month DOR rates in the pembrolizumab arm were 46.6% and 26.5% compared with 28.4% and 14.5% in the placebo arm.

“These data support the use of pembrolizumab plus weekly paclitaxel, with or without bevacizumab, as a new standard of care for patients with [recurrent] PROC,” presenting author Nicoletta Colombo, MD, PhD, of the Gynecologic Oncology Program at the European Institute of Oncology, IRCCS, in Milan, Italy, and the Department of Medicine and Surgery at the University of Milan-Bicocca in Italy, wrote with coauthors in the presentation.

Safety Analyses

Any-grade treatment-related adverse events (TRAEs) occurred in 97.8% of the pembrolizumab arm and 95.3% of the placebo arm; grade 3 or higher TRAEs occurred in 67.5% and 55.3%, respectively. TRAEs were serious in 33.1% and 19.5%, led to death in 0.9% and 1.6%, and led to discontinuation of any treatment in 35.9% and 28.0%.

Any-grade immune-mediated AEs occurred in 39.1% and 18.9%, and grade 3 or higher events occurred in 11.6% and 3.5%. They were serious events in 10.9% and 2.2%, and led to treatment discontinuation in 6.9% and 2.5%.

The most common TRAEs in both groups included anemia (49.7% vs 42.1%, respectively), peripheral neuropathy (38.8% vs 31.1%), alopecia (37.8% vs 34.0%), fatigue (35.3% vs 33.0%), and nausea (31.3% vs 27.4%). The most common immune-mediated AEs were hypothyroidism (17.8% vs 6.0%), infusion reactions (5.9% vs 4.7%), and hyperthyroidism (5.0% vs 0.6%).

Trial Breakdown

A total of 643 patients with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were enrolled in the trial and randomly assigned to either the pembrolizumab arm (n = 322) or the placebo arm (n = 321). Treatment was either pembrolizumab at 400 mg once every 6 weeks for 18 cycles or placebo on the same schedule; all patients received paclitaxel at 80 mg/m² on days 1, 8, and 15 of each 3-week-long cycle, and they either did or did not receive bevacizumab at 10 mg/kg every 2 weeks.

Patients were enrolled in the trial if they had received 1 or 2 prior lines of therapy with at least 1 platinum-based chemotherapy; prior anti-PD-1 or anti-PD-L1 agents, PARP inhibitors, and bevacizumab were permitted. Additionally, patients had radiographic progression within 6 months after the last dose of platinum-based chemotherapy and an ECOG performance status of 0 or 1.

The primary end point of the trial was PFS per RECIST v1.1 by investigator assessment, and a key secondary end point was OS.

The median age of patients was 62 years vs 61 years in the pembrolizumab vs placebo arm, 64.3% and 67.6% of patients were White, 41.3% and 41.1% had a PD-L1 CPS from 1 to less than 10, and 31.4% and 31.2% had a PD-L1 CPS of at least 10.

Reference

Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Presented at: European Society of Medical Oncology Congress 2025; October 17–20, 2025; Berlin, Germany. Abstract LBA3.

Tim Brown will remember 12 December 2020 for ever.

It was the day the software company SolarWinds was notified it had been hacked by Russia.

Brown, the chief information security officer at SolarWinds, immediately understood the implications: any of the company’s more than 300,000 global clients could be affected too.

The exploit allowed the hackers remote access to the systems of customers that had installed SolarWinds’ network software Orion, including the US treasury department, the US department of commerce’s National Telecommunications and Information Administration, along with thousands of companies and public institutions.

Brown says he was “running on adrenaline” in the first few days after the attack.

It was during the early stages of the Covid pandemic when full-time work-from-home was the norm, but the company’s email was compromised and couldn’t be used to communicate with staff.

“We gave up on the phones and just everybody came into the office and we got Covid testing,” Brown says. “I lost 25 pounds in about 20 days … just going, going, going.”

He appeared on CNN and 60 Minutes, and in every major newspaper.

“The world’s on fire. You’re trying to get information out and trying to have people understand what’s safe and what’s not safe.”

The company switched to Proton email and Signal while its email was compromised, Brown says. He was taking calls from companies and government agencies across the globe, including the US army and the Covid vaccine program Operation Warp Speed.

“You get the world wanting verbal communication not written communication. And that is a kind of an important lesson: you can write things down, but they want to talk to the [chief information security officer],” says Brown, who spoke at Melbourne’s CyberCon on Friday.

“They want to be able to hear colour around the outside of it, so very important to be prepared for that kind of response.”

How the cyber-attack unfolded

The notification about the hack came in a phone call from Kevin Mandia, the founder of the cybersecurity firm Mandiant, to SolarWinds’ then CEO Kevin Thompson.

Mandia told Thompson that SolarWinds had “shipped tainted code” to its Orion software, which helps organisations monitor outages on their computer networks and servers.

The exploit in Orion was being used to attack government agencies, Mandia told Thompson.

“We could see in that code [it] was not ours, so when we got that, it was ‘all right, this is real’,” Brown recalls.

The Texas-based SolarWinds determined that 18,000 people had downloaded the tainted product, which the hackers, later attributed to the Russian Foreign Intelligence Service, were able to insert into Orion in the build environment where source code is turned into software.

The news broke on the Sunday. SolarWinds notified the stock market before it opened on Monday.

The original estimate that up to 18,000 clients could be affected was later revised down to about 100 government agencies and companies that actually were.

“It would have been nice to know that on day one, but that was the truth of the matter, right?” Brown says. “We weren’t really the target. We were just a route to the target.”

SolarWinds called in CrowdStrike, KPMG and the law firm DLA Piper to deal with the response and investigation.

Aftermath: the heart attack

SolarWinds stopped work on new features for the next six months and its team of 400 engineers focused on systems and security to get the company back on its feet.

“We really took transparency to heart – how can we make sure people realise [what] threat actor models [are out there], what they do, how they do reconnaissance, how they then do an attack [and] how they then leave.”

Brown says the company’s customer renewal rate fell into the 80% range in the first few months after the incident, but has since returned to more than 98%.

But then came the legal implications.

The Biden administration imposed sanctions and expelled Russian diplomats in 2021, partly in response to the attack.

SolarWinds settled a class action lawsuit over the attack in 2022 for US$26m. The Securities and Exchange Commission (SEC) then filed a lawsuit against SolarWinds and Brown personally in October 2023, accusing the company and Brown of misleading investors over its claims about cybersecurity protections, and failing to disclose known vulnerabilities.

Brown was in Zurich when he found out he was being charged.

“When I walked up a hill, I would lose my breath. My arms would get heavy, my chest would get tight. I was just not getting enough oxygen,” he says. “I did a silly thing. I flew home … I couldn’t walk from the terminal to my car without stopping. That’s a walk I had done thousand of times.”

He was having a heart attack. When he got home, his wife took him to the hospital, where he underwent surgery. He has since recovered.

“Stress keeps building up and I thought I was managing it well and I didn’t proactively go to a doctor,” he says.

Brown says he now advocates for companies going through similar incidents to employ psychiatrists to help staff process the stress.

“The stress level was pumped up, and then it just went over the edge, but stress was building up all the time.”

A confidential jointly proposed settlement with the SEC was announced in July, but has yet to be approved. The US government shutdown has delayed the finalisation of the agreement.

Brown has remained with SolarWinds throughout the process.

“It happened on my watch, that’s how I look at it. There are reasons why it occurred, nation state attack, et cetera, but still it happened on my watch,” he says.

“I guess I’m stubborn. But it was just very important for us to get through this whole cycle, so leaving wasn’t an option until it was done.”

Wikipedia is often described as the last good website on an internet increasingly filled with toxic social media and AI slop. But it seems the online encyclopedia is not completely immune to broader trends, with human pageviews falling 8% year-over-year, according to a new blog post from Marshall Miller of the Wikimedia Foundation.

The foundation works to distinguish between traffic from humans and bots, and Miller writes that the decline “over the past few months” was revealed after an update to Wikipedia’s bot detection systems appeared to show that “much of the unusually high traffic for the period of May and June was coming from bots that were built to evade detection.”

Why is traffic falling? Miller points to “the impact of generative AI and social media on how people seek information,” particularly as “search engines are increasingly using generative AI to provide answers directly to searchers rather than linking to sites like ours” and as “younger generations are seeking information on social video platforms rather than the open web.” (Google has disputed the claim that AI summaries reduce traffic from search.)

Miller says the foundation welcomes “new ways for people to gain knowledge” and argues this doesn’t make Wikipedia any less important, since knowledge sourced from the encyclopedia is still reaching people even if they don’t visit the website. Wikipedia even experimented with AI summaries of its own, though it paused the effort after editors complained.

But this shift does present risks, particularly if people are becoming less aware of where their information actually comes from. As Miller puts it, “With fewer visits to Wikipedia, fewer volunteers may grow and enrich the content, and fewer individual donors may support this work.” (Some of those volunteers are truly remarkable, reportedly disarming a gunman at a Wikipedia editors’ conference on Friday.)

For that reason, he argues that AI, search, and social companies using content from Wikipedia “must encourage more visitors” to the website itself.

And he says Wikipedia is taking steps of its own, for example by developing a new framework for attributing content from the encyclopedia. The organization also has two teams tasked with helping Wikipedia reach new readers, and it’s looking for volunteers to help.

Miller also encourages readers to “support content integrity and content creation” more broadly.

“When you search for information online, look for citations and click through to the original source material,” he writes. “Talk with the people you know about the importance of trusted, human curated knowledge, and help them understand that the content underlying generative AI was created by real people who deserve their support.”

This article first appeared on GuruFocus.

Release Date: October 17, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

• Reliance Industries Ltd (WBO:RLI) reported strong performance across all business segments, with a notable 18% growth in EBITDA for Jio, driven by strong customer additions in both mobility and home segments.

• The retail segment saw a robust year-on-year growth of 17% in EBITDA, with revenues increasing by 18%, supported by significant growth in fashion, lifestyle, grocery, and electronics categories.

• The energy business reported a 21% increase in performance, driven by higher cracks across gasoline, gas oil, and ATF, along with increased domestic placements.

• Reliance Industries Ltd (WBO:RLI) is making significant progress in its new energy initiatives, with plans to start renewable energy round-the-clock power plants in Kutch next year.

• The company is expanding its digital services and AI capabilities, with Reliance Intelligence set to develop AI products and solutions, leveraging partnerships with global tech companies like Meta.

• Despite strong overall performance, the upstream segment experienced a decline due to natural production falls in the KGD6 fields.

• Finance costs increased by 14%, and depreciation rose by 12%, primarily due to 5G capitalization and spectrum interest.

• The petrochemical segment faced challenges with weak demand for PVC and PET due to heavy rains and floods affecting agricultural and packaging sectors.

• The media business, while showing growth, faces challenges in maintaining momentum post-IPL, with a need to convert cricket audiences to entertainment content.

• The geopolitical situation and increased OSPs have impacted the refining margins, despite high cracks in the refining segment.

Q: Are there any plans for a tariff hike in the near future? A: Unidentified_2: No immediate plans for a tariff hike. We are encouraging consumers to use more services, but there are no current plans to change tariffs.

Q: Is the current monthly run rate for connecting new homes expected to increase? A: Unidentified_2: We expect to ramp up the rate of connecting new homes. The technology is working well, and many new connections are being done wirelessly, allowing for simpler and faster implementation.

Q: How will Reliance Intelligence and Geo Platforms collaborate on AI initiatives? A: Unidentified_2: Reliance Intelligence will develop AI products and solutions, while Geo Platforms will bring these to market. Geo Platforms can also work with other partners like Meta, OpenAI, and Google.

Q: What is the status of the battery cell assembly plant, and how is Reliance handling equipment sourcing given China’s export restrictions? A: Unidentified_8: The battery cell factories are progressing well, and we have secured all equipment for the first phase of cell manufacturing. Equipment sourcing is happening globally, and we are monitoring the impact of new regulations.

Q: How is the Quick commerce model different from other models, and what advantages does it offer? A: Unidentified_3: The Quick commerce model has pivoted to focus on instant deliveries, offering the widest assortment, best pricing, and no hidden charges. The model leverages a vast store network and localized assortment knowledge, providing a significant advantage over competitors.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Adjuvant treatment with cemiplimab-rwlc (Libtayo) was associated with a similar incidence of second primary tumors (SPTs) compared with placebo in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery and postoperative radiotherapy, according to findings from an analysis of the phase 3 C-POST trial (NCT03969004) presented at the 2025 ESMO Congress.¹

During the treatment period, the proportion of patients who developed at least one SPT was 11% in the cemiplimab arm (n = 209) compared with 12% in the placebo arm (n = 206); during the study’s follow-up period, these rates were 8% and 7%, respectively. During the treatment period, the cumulative number of SPTs was 32 with cemiplimab vs 82 for placebo, corresponding to annualized, adjusted annualized SPT rates of 1.23 (95% CI, 0.60-2.54) and 2.81 (95% CI, 1.23-6.45), respectively. In the follow-up period, 36 total SPTs occurred in the cemiplimab arm vs 41 in the placebo arm, and the annualized SPT rates were 0.72 (95% CI, 0.30-1.71) and 1.17 (95% CI, 0.40-3.49), respectively.

During the treatment period, 9% of patients in the cemiplimab arm had 1 SPT, 1% had 2 SPTs, less than 1% had 3 SPTs, 0% had 4 SPTs, less than 1% had 5 SPTs, and 0% had 6 or more SPTs. In the placebo arm, these rates were 8%, 2%, less than 1%, less than 1%, 0%, and 1%, respectively. Incidence was similar during the follow-up period, with 4% of patients in each arm experiencing 1 SPT and less than 1% of patients falling into the multiple SPT groups within each arm.

In a post hoc analysis incorporating the first occurrence of SPTs alongside disease-free survival (DFS) events (recurrence or death), efficacy continued to favor cemiplimab over placebo (HR, 0.43; 95% CI, 0.30-0.60). The median DFS in this analysis was not reached (NR; 95% CI, not evaluable [NE]-NE) in the cemiplimab group vs 21.7 months (95% CI, 12.9-39.2) in the placebo group. At 24 months, DFS rates were 81.1% with cemiplimab vs 59.1% with placebo, and this benefit was maintained over time, with rates of 73.4% vs 48.7% at 36 months and 68.4% vs 41.5% at 48 months, respectively.

“The lower number of SPTs in the cemiplimab arm appeared to be driven by a small number of patients with multiple SPTs observed in the placebo arm. The robust [DFS] efficacy signal with cemiplimab vs placebo was maintained in a post hoc analysis in which SPTs were included as [DFS] events,” Danny Rischin, MD, who serves as the director of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, noted in the conclusion of his presentation. “These prospective, randomized data suggest that there may be a subset of patients who experience fewer SPTs with cemiplimab, although further investigation is required.”

What Was Established in the Primary Analysis of the C-POST Trial?

With a median follow-up of 24 months (range, 2-64), previously reported findings from the primary analysis showed that patients who received adjuvant cemiplimab after surgical resection and postoperative radiotherapy achieved a median DFS that was NR (95% CI, NE-NE) compared with 49.4 months (95% CI, 48.5-NE) among those treated with placebo (n = 206; HR, 0.32; 95% CI, 0.20-0.51; P < .001). The estimated 24-month DFS rates were 87.1% (and 64.1%, respectively.

Based on those findings, on October 8, 2025the FDA approved cemiplimab for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.² Following this decision, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the agent’s use in the same indication.³

What Was the Design of the C-POST Trial and the Post Hoc Analysis?

The phase 3 C-POST trial is a randomized, double-blind, placebo-controlled study designed to evaluate adjuvant cemiplimab in patients with histologically confirmed CSCC who had undergone complete resection with curative intent and completed postoperative radiotherapy.¹ Patients were required to have high-risk features, which included nodal extracapsular extension with at least one lymph node measuring 20 mm or more, or three or more involved lymph nodes; in-transit metastases; perineural invasion; T4 lesions; or recurrent CSCC with 1 or more additional high-risk characteristics.

Participants were randomly assigned 1:1 to receive cemiplimab or placebo. In part 1 of the study, patients received cemiplimab at 350 mg intravenously every 3 weeks for 12 weeks, followed by cemiplimab at 700 mg every 6 weeks for an additional 36 weeks. Those in the control group received matched placebo on the same schedule. Treatment continued until completion of the planned duration, disease recurrence, or unacceptable toxicity.

Patients who experienced recurrence after completing placebo treatment or after at least three months following cemiplimab completion were eligible to enter an optional open-label extension phase (part 2) to receive cemiplimab at 350 mg every 3 weeks for up to 96 weeks.

The primary end point of the trial was DFS. Key secondary end points include freedom from locoregional recurrence, freedom from distant recurrence, cumulative occurrence of second primary tumors, overall survival, and safety.

The median age of patients was 71.0 years (range, 33-87) in the cemiplimab group and 70.5 years (range, 36-95) in the placebo group. Most patients were 65 years of age or older, representing 73% and 68% of each respective arm. The majority of participants were male (83% in both arms) and White (90% vs 92%).

Geographically, 43% of patients in the cemiplimab arm and 44% in the placebo arm were enrolled from Australia or New Zealand, 18% and 15% were from North America, and 39% and 41% were from the rest of the world.

Most patients had resected high-risk tumors located in the head and neck region (79% in the cemiplimab group vs 86% in the placebo group), and 21% and 14% had non–head and neck tumors, respectively. Regarding risk classification, 60% of patients in the cemiplimab arm and 57% in the placebo arm were categorized as having nodal high-risk disease; 40% and 43%, respectively, had non-nodal high-risk features.

Disclosures: Rischin reported receiving institutional research funding from ALX Oncology, AstraZeneca, Bicara Therapeutics, Decibel Therapeutics, Erasca, Marck, and Regeneron Pharmaceuticals; and having uncompensated relationships with Eisai, GSK, Merck, and Regeneron Pharmaceuticals.

References

1. Rischin D, Porceddu S, Day F, et al. Analysis of second primary CSCC tumors (SPTs) reported during the C-POST trial, a randomized phase 3 study of adjuvant cemiplimab vs placebo for high-risk CSCC. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 1603MO.
2. FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma. FDA. October 8, 2025. Accessed October 18, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma
3. Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence after surgery and radiation. News release. Regeneron. October 17, 2025. Accessed October 18, 2025. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-recommended-eu-approval-chmp-adjuvant

Story Continues

A ‘perfect storm’ lifts gold

Kyle Rodda, senior financial market analyst, said a “perfect storm” of global factors has pushed gold prices higher. Rising trade tensions between the United States and China, expectations of another Federal Reserve rate cut, and worries about regional banks have all driven investors toward safe-haven assets like gold.

Rodda, who is a market analyst at Capital.com, described the surge as “parabolic,” noting that prices have risen unusually fast. “Gold is sending an ominous message about the future,” he said. “It could be pointing to global instability or a sign of speculation that might burst later.”

Central banks and ETFs fuel demand

Gold’s year-to-date performance has been remarkable, up nearly 59%. Central banks worldwide have been buying gold at record levels, while a weaker US dollar and falling interest rates have made holding gold more attractive than cash or bonds.

At the same time, gold-backed exchange-traded funds (ETFs) saw record inflows last quarter, highlighting strong appetite from both retail and institutional investors.

Why investors are buying gold

A Bank of America Fund Managers Survey recently found that gold is the most crowded trade in the market, beating out the “Magnificent Seven” tech stocks. 39% of fund managers have no gold, 35% have 2-4% of their portfolio in gold.

Also Read: Gold, silver prices hit records on US credit fears and ‘US-China trade war’

Wall Street raises its price forecasts

Several major banks have lifted their gold price targets. BofA analysts reiterated their “long gold” call, predicting prices could reach $6,000 per ounce by mid-2026. Goldman Sachs raised its forecast to $4,900 by the end of next year, and JPMorgan expects prices could climb to $6,000 by 2029.

For now, gold’s upsurge is due to global uncertainty and investor nervousness. Whether it continues or becomes a bubble will depend on how central banks and the world economies react to inflation, rate cuts and geopolitical risks in the coming months.

Also Read: No Kings protests to sweep US as millions plan to march against Trump’s policies

FAQs:

Why did gold prices rise so much this week?

Gold prices rose due to trade tensions, rate-cut expectations, and worries about banks, making investors buy gold as a safe option.

How high did gold prices go?

Gold futures reached an intraday high of around $4,380 an ounce before ending the week near $4,260.

Will gold prices keep rising?

Experts say prices may rise further if global uncertainty, inflation, and interest rate cuts continue, but some warn it could become a bubble.