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Monday, August 4, 2025

'More Colorectal Cancers Detected in Younger Adults After Guideline Change'

 

  • The recommendation to begin colorectal cancer screening at ages 45 to 49 has increased participation rates in this younger age group.
  • Earlier screening appears to have increased the earlier detection of asymptomatic cancers.
  • A strategy involving mailing unsolicited FIT kits was more effective in increasing screening participation compared with three other screening strategies requiring active choice.

The proportion of younger adults undergoing colorectal cancer (CRC) screening has increased in the years after recommendations were first revised to include average-risk individuals ages 45 to 49, and this led to earlier detection of asymptomatic cancers in this age group, according to two studies.

In a study looking at screening participation trendsopens in a new tab or window using data from the National Health Interview Survey, CRC screening steadily increased among U.S. adults ages 45 to 49 after the American Cancer Societyopens in a new tab or window and U.S. Preventive Services Task Forceopens in a new tab or window (USPSTF) issued revised recommendations in 2018 and 2020, respectively, reported Jessica Star, MA, MPH, of the American Cancer Society, and colleagues in JAMA.

In a second studyopens in a new tab or window, also published as a research letter in JAMA, there was a steep increase in local-stage CRC incidence in adults ages 45 to 49 from 2019 to 2022, said Elizabeth J. Schafer, MPH, also of the American Cancer Society, and colleagues.

In addition, a randomized trialopens in a new tab or window found that the most effective way to promote CRC screening in this younger group was to send unsolicited fecal immunochemical test (FIT) kits, reported Folasade P. May, MD, PhD, of the University of California Los Angeles, and colleagues.

The revised screening recommendations raised a number of questions, including whether expanding eligibility to younger adults would divert resources from and compromise progress made in screening older adults, whether lowering the screening age would affect population-level outcomes, and which strategies are needed to reach those individuals newly eligible for screening, wrote Caitlin C. Murphy, PhD, MPH, of the UTHealth Houston School of Public Health, and colleagues in an editorial accompanying the three studiesopens in a new tab or window.

The good news, the editorialists noted, is that despite some concerns about unintended consequences of earlier screening, the results from these studies "begin to answer these questions, and together, they provide encouraging signals that may assuage initial skepticism."

Increased Screening Participation

Among adults ages 45 to 49 years, the prevalence of up-to-date CRC screening increased from 20.8% in 2019 and 19.7% in 2021 to 33.7% in 2023, Star and team reported.

Colonoscopy prevalence increased from 19.5% in 2019 and 17.8% in 2021 to 27.7% in 2023, while stool-based testing increased from 1.3% and 2.7% to 7.1%, respectively.

The researchers also found that screening for adults ages 50 to 75 remained stable, "suggesting no reduced access for older individuals," they wrote.

Evidence of screening participation in the younger group of adults "is encouraging because screening reduces CRC mortality, mostly through the detection and removal of potentially precancerous lesions," Star and colleagues noted. However, they added that these increases were restricted to highly educated and insured individuals, "which may foreshadow widening disparities."

Of 18,645, 17,300, and 17,293 survey respondents ages 40 to 75 in 2019, 2021, and 2023, 14.8%, 13.9%, and 14% were ages 45 to 49. Most of these younger respondents were white and privately insured.

Colorectal Cancer Incidence

CRC incidence increased steadily by 1.6% annually since 2004 among adults ages 20 to 39 and by 2% to 2.6% annually since 2012 among adults ages 40 to 44 and 50 to 54, reported Schafer and team.

Notably, among those ages 45 to 49, an increase of 1.1% annually from 2004 to 2019 skyrocketed to 12% annually during 2019 to 2022.

This steep increase was driven by local-stage tumors (annual percentage change 21.8%, 95% CI 13.8-26.2), with an increase from 9.4 per 100,000 in 2019 to 11.7 per 100,000 in 2021 (a 25% relative increase), and then to 17.5 per 100,000 in 2022 (a 50% increase relative to 2021), after stable rates from 2004 to 2019.

Schafer and colleagues contrasted those substantial increases with consistent increases of distant-stage diagnoses observed in that age group, which "likely reflects diagnosis of prevalent asymptomatic cancer through first-time screening due to recommendations for adults to begin screening at age 45 years instead of 50 years."

For this study, Schafer and colleagues used data on CRC cases diagnosed from 2004 to 2022 among adults ages 20 to 54 that were obtained from 21 registries in the Surveillance, Epidemiology, and End Results (SEER) Program.

They identified a total of 219,373 cases of CRC (119,877 men, 99,496 women, mean age 46.9 years) during that period.

In their editorial, Murphy and colleagues noted that it isn't clear if the increased rates in the incidence of local-stage disease reflect slow-growing, indolent tumors, or if the detection of asymptomatic cancers will ultimately lead to decreased mortality.

"It will be important to monitor population-level outcomes as screening participation continues to increase among adults aged 45 to 49 years, as well as critical to determine the effect on mortality," they wrote.

Optimal Screening Strategy

In the randomized trial among adults ages 45 to 49, mailing an unsolicited FIT kit was more effective in increasing screening participation compared with three other CRC screening strategies requiring active choice through an electronic health record portal, May and team reported.

The single-center trial included 20,509 participants randomized to one of four outreach strategies: FIT-only active choice, colonoscopy-only active choice, dual-modality (FIT or colonoscopy) active choice, and usual care default mailed FIT outreach.

Screening participation was significantly lower in each of the three active-choice groups (FIT only: 16.4%; colonoscopy only: 14.5%; dual-modality FIT or colonoscopy: 17.4%) compared with the usual care default mailed FIT group (26.2%; all P<0.001).

The authors noted that, overall, screening rates were low, "underscoring the need for more effective strategies to engage this group."

The editorialists concluded that results from the studies suggested that "the critical next steps are to evaluate longer-term outcomes, especially mortality, and to ensure benefits are equally realized by scaling up implementation across diverse settings."

Disclosures

Schafer's study was supported by the Intramural Research Department of the American Cancer Society.

The randomized trial was funded by the UCLA Melvin and Bren Simon Gastroenterology Quality Improvement Program and a grant from the National Science Foundation Social Science Research Council.

Star and colleagues reported no conflicts of interest.

Schafer and colleagues reported no conflicts of interest.

May reported serving on the advisory board for Exact Sciences, Medtronic, and Geneoscopy.

Co-authors reported grants from the National Science Foundation, the NBER Roybal Center for Behavior Change in Health, and the USC Roybal Center for Behavioral Interventions in Aging.

Murphy reported consulting for Freenome and Universal Diagnostics. Co-authors reported no conflicts of interest.

Primary Source

JAMA

Source Reference: opens in a new tab or windowStar J, et al "Trends in colorectal cancer screening in US adults aged 45 to 49 years" JAMA 2025; DOI: 10.1001/jama.2025.10618.

Secondary Source

JAMA

Source Reference: opens in a new tab or windowSchafer EJ, et al "Colorectal cancer incidence in US adults after recommendations for earlier screening" JAMA 2025; DOI: 10.1001/jama.2025.9147.

Additional Source

JAMA

Source Reference: opens in a new tab or windowGaloosian A, et al "Population health colorectal cancer screening strategies in adults aged 45 to 49 years: a randomized clinical trial" JAMA 2025; DOI: 10.1001/jama.2025.12049.

Additional Source

JAMA

Source Reference:opens in a new tab or window Murphy CC, et al “Younger adults, earlier screening — what we are learning about colorectal cancer and what comes next” JAMA 2025; DOI: 10.1001/jama.2025.11473.


https://www.medpagetoday.com/hematologyoncology/coloncancer/116815

BioNTech Commits to Infectious Diseases Amid Questions Over Vaccine Demand

 

The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady.

BioNTech has made the case for continuing to invest in infectious diseases amid its pivot to oncology and questions about demand for vaccines in the U.S.

The Pfizer-partnered COVID-19 vaccine Comirnaty is BioNTech’s key sales driver today but the company’s R&D teams are focused on bringing oncology candidates to market. While the cancer assets are central to BioNTech’s future, the company used its second-quarter earnings on Monday to confirm its intent to continue investing in its COVID-19 vaccines and in next-generation and combination shots.

During BioNTech’s earnings call, Bank of America analyst Tazeen Ahmad asked why it makes sense to keep investing in the infectious disease pipeline at a time when there is evidence vaccination rates are falling. Ryan Richardson, BioNTech’s chief strategy officer, outlined how the company can stimulate demand.

“Our COVID-19 vaccine business is going to continue to be a priority,” Richardson said. “As it relates to your question about what’s driving demand, I think ultimately it’s going to continue to be based on the value proposition of these vaccines. So, we’re going to continue to work on next-generation concepts, including exploring combination vaccines, that we think could add additional value for patients.”

BioNTech CFO Ramón Zapata told analysts the company’s revenue outlook for 2025 assumes COVID-19 vaccination rates will be lower in 2025 than last year given the “market dynamics and shifting policy.” Zapata said BioNTech expects that the U.S. vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady.

In oncology, BioNTech is working to bring its PD-L1xVEGF-A bispecific BNT327 to market. The candidate originated in China and some of the clinical evidence for the molecule comes from Chinese sites. With the FDA rejecting a filing for Roche’s Columvi over a lack of U.S. data, an analyst asked BioNTech if it has seen any shift in the agency’s willingness to accept results from Chinese sites.

In response, BioNTech CMO Özlem Türeci said discussions with the FDA “are very positive” and pointed to the data the company has generated in Western populations. Türeci said BioNTech expects to be able to move ahead in its three lead indications “within the next couple of weeks.”

BioNTech reported revenues of 260.8 million euros (~$302 million), up from 128.7 million euros (~$149 million) in the second quarter of 2024. The company attributed the increase to higher revenues from its COVID-19 vaccine collaboration with Pfizer. R&D costs fell as BioNTech reprioritized clinical trials toward its focus programs.

The company reaffirmed its full-year guidance. BioNTech continues to expect revenues of 1.7 billion to 2.2 billion euros (approximately $2 billion to $2.5 billion) and R&D expenses of 2.6 billion to 2.8 billion euros (~$3 billion to $3.2 billion). The full-year forecast reflects the assumption that sales will be concentrated in the final three to four months of 2025, when the COVID-19 vaccination season will be underway and a new variant-adapted vaccine could be on the market.

https://www.biospace.com/business/biontech-commits-to-infectious-diseases-amid-questions-over-vaccine-demand

Allogene Scraps Immunosuppressive Antibody After Patient Death in Lymphoma Trial

 

The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy.

A patient has died in Allogene Therapeutics’ Phase II ALPHA3 trial of cemacabtagene ansegedleucel, an investigative CAR T therapy for the treatment of large B-cell lymphoma.

However, the mortality wasn’t linked with the cell therapy itself, also known as cema-cel. Instead, Allogene attributed the death to ALL-647, a monoclonal antibody that targets the CD52 protein and was being used by the biotech as a lymphodepletion therapy to prepare patients for cema-cell treatment.

According to Allogene’s news release on Friday, the death was linked to liver failure, which in turn arose from “disseminated adenovirus infection in the setting of immune suppression.” The patient in question died 54 days after infusion. Severe infections such as these have been “rare” across Allogene’s trials, the biotech said, but “when present, they have been attributed to immunosuppression due in part to ALLO-647.”

Writing to investors on Friday afternoon, analysts at William Blair called the patient mortality “highly unfortunate,” and agreed with the company that “available evidence supports that the event was attributed to ALLO-647-mediated prolonged T-cell suppression rather than cema-cel.”

Allogene stock dropped 12% in trading Friday.

Owing to the mortality, Allogene has decided to discontinue the study arm that was using ALLO-647 as part of the immunosuppressive regimen and drop the antibody from its pipeline altogether. Instead, the biotech will move forward with only using fludarabine and cyclophosphamide (FC) as lymphodepletion treatments for patients receiving cema-cel. Allogene expects a futility analysis for ALPHA3 in the first half of 2026.

“We are supportive of the company’s decision to discontinue the FCA regimen in the ALPHA3 study,” William Blair wrote on Friday, however warning that “the standard lymphodepletion regimen with FC likely will not lead to as robust cema-cel expansion and persistence” as when ALLO-647 is added onto the regimen.

Still, the analysts noted that patients enrolled in ALPHA3 have lower burdens of disease, “suggesting that an enhanced lymphodepletion regimen may not be required.” Moving forward with just the FC regimen could also lead to “potentially higher commercial uptake” for cema-cel, if approved, “given the lower safety risks,” William Blair contended.

https://www.biospace.com/drug-development/allogene-scraps-immunosuppressive-antibody-after-patient-death-in-lymphoma-trial

Fed's Daly says time is nearing for rate cuts, may need more than two

 San Francisco Federal Reserve Bank President Mary Daly on Monday said that given mounting evidence that the U.S. job market is softening and no signs of persistent tariff-driven inflation, the time is nearing for interest rate cuts.

"I was willing to wait another cycle, but I can't wait forever," Daly said of the Fed's decision last week to leave short-term borrowing costs in their 4.25%-4.50% range rather than cut them, as a couple of her colleagues wanted and as President Donald Trump has demanded.

While that doesn't mean a September rate cut is a lock, she said, "I would lean to thinking that every meeting going forward is a live meeting to think about these policy adjustments."

The two quarter-point interest-rate cuts that Fed policymakers back in June penciled in for this year still "look to be an appropriate amount of recalibration, and less important is, does it happen in September and December than does it happen at all...there's all kinds of permutations to get those two cuts."

Daly said there is still plenty of data including a couple of labor market and inflation reports due out before the Fed's policy-setting meeting, in September, and she's keeping an open mind.

"We of course could do fewer than two (rate cuts) if inflation picks up and spills over or if the labor market springs back," Daly said. But "I think the more likely thing is that we might have to do more than two...we also should be prepared in my judgment to do more if the labor market looks to be entering that period of weakness and we still haven't seen spillovers to inflation."

A Labor Department report Friday showed U.S. employers added just 73,000 jobs last month, and massive revisions to previously reported data showed only 33,000 jobs were added in the two prior months.

Those figures, to Daly's mind, don't mean the job market is precariously weak - in times of economic flux, she said, raw employment numbers are often less informative than ratios like the unemployment rate, which ticked up just a tenth of a percentage point in July to 4.2%.

Still, she said, looking at a broad dashboard of labor-market measures, there is "evidence after piece of evidence" that the labor market is softening quite a bit compared to last year.

"I would see further softening as an unwelcome result," she said. "I'm comfortable with the decision we made in July, but I am increasingly less comfortable with making that decision again and again."

At the same time, she said, there's no evidence that tariff-driven price increases are seeping more broadly into inflation, and if the Fed waits long enough to be certain it won't -- a process that could take six months or a year, she said - the Fed will "for sure" be too late to move.

The Fed is approaching a "tradeoff space where you are trying to make a judgment about where does policy need to be to continue to put downward pressure on inflation, and where does it need to be to continue to make sure that sustainable employment can be achieved," she said. "That's why I didn't think that July was a necessary change, but I do think, increasingly, policy is not aligned."

https://uk.finance.yahoo.com/news/exclusive-feds-daly-says-time-200727179.html

Warren gushes over NYC mayoral candidate Mamdani — as other high-profile Dems stay silent

 It’s a steel.

Progressive Sen. Elizabeth Warren heaped praise Monday on socialist mayoral contender Zohran Mamdani’s “steely” focus on affordability — casting it as a winning path out of the political wilderness for Democrats.

Warren, who appeared alongside Mamdani at the DC37 union building to support his universal childcare proposal, said he kick-started that conversation in the right place.

“For me, New York City is the place to start the conversation for Democrats on how affordability is the central issue, the central reason to be a Democrat, and that delivering on it in meaningful, tangible ways that will touch working families is why we’re here,” Warren said.

Elizabeth Warren and Zohran Mamdani
Sen. Elizabeth Warren offered praise for NYC mayoral candidate Zohran Mamdani on Monday.Matthew McDermott

“That is the Democratic message… Zohran is on the front lines in that fight out there, fighting for families.”

The Massachusetts senator’s blessing came as Mamdani continues to struggle to gain actual endorsements from other high-profile Dems, notably his fellow New Yorkers Chuck Schumer, the Senate’s minority leader and House Minority Leader Hakeem Jeffries.

Both Schumer and Jeffries avoided outright endorsing Mamdani after the Queens state Assemblyman trounced former Gov. Andrew Cuomo in June’s Democratic mayoral primary — an upset that prompted a wave of soul-searching among more moderate Dems wary of a socialist being the party’s standard-bearer.

Warren, who unsuccessfully ran for president in 2020, also recently attacked Cuomo and incumbent Mayor Eric Adams, who are both running as independents in November, for allegedly cozying up to billionaires.

Zohran Mamdani
Mamdani speaks to reporters after Warren heaped praise on him Monday.Matthew McDermott

“Cuomo and Adams are tripping over themselves to haul in millions of campaign dollars from billionaire donors,” she wrote in Rolling Stone.

“Mamdani has charged ahead with plans to make New York more affordable, and he’s showing how to pay for it by taxing the ultra-rich and giant corporations. That may not make him popular with the richest New Yorkers, but he’s willing to let Adams and Cuomo suck up to those guys.”

This breaking a story. Please check back for updates.

https://nypost.com/2025/08/04/us-news/far-left-sen-warren-gushes-over-nyc-mayoral-candidate-zohran-mamdani-as-other-high-profile-dems-stay-silent/

Russia fades Medvedev as Trump says ordered nuke subs closer to Moscow: ‘No winner in nuke war’

 The Kremlin tried Monday to defuse tensions caused by remarks from one of Russia’s top officials that led President Trump to shift two nuclear submarines closer to Moscow.

“As you know, Russia holds a responsible position. President Putin’s stance is well known,” Kremlin spokesperson Dmitry Peskov told reporters, according to the official TASS news agency.

“Russia takes the issue of nuclear non-proliferation very seriously,” Peskov added. “And, of course, we believe that everyone should be extremely careful when it comes to nuclear rhetoric.”

President Donald Trump boards Air Force One on August 1, 2025 at Joint Base Andrews, Maryland.Getty Images
Ohio-class nuclear-powered submarines are the most likely to have been dispatched closer to Russia.Merrill Sherman / NYPost Design

Former Russian President Dmitry Medvedev had taunted Trump last week in a flurry of posts on X about the US possibly deploying additional sanctions on Moscow over its invasion of Ukraine — insisting that “each new ultimatum is a threat and a step towards war.”

Medvedev, now deputy chairman of the Security Council of Russia, previously warned Trump of World War III in May in response to the US president’s criticisms of Putin.

On Friday, Trump responded by announcing he was moving two nuclear submarines to “appropriate regions.”

Medvedev, a close ally of Putin and deputy chairman of Russia’s Security Council, taunted Trump in a series of posts on X last week.ZUMAPRESS.com
The US repositioned submarines to send a message to Russia as frustration over the lack of a cease-fire grows.ZUMAPRESS.com
“I have ordered two Nuclear Submarines to be positioned in the appropriate regions, just in case these foolish and inflammatory statements are more than just that,” he added, without further detailing where the vessels had been positioned.

https://nypost.com/2025/08/04/us-news/russia-backs-off-medvedev-rhetoric-after-trump-says-he-ordered-nuke-subs-closer-to-moscow/