STAT+: For prostate cancer patients set on surgery, new hormone regimen may improve outcomes, study finds

CHICAGO — Patients with high risk prostate cancer that hasn’t spread typically have two standard treatment paths before them. Remove the prostate surgically, or do a combination of radiation therapy and hormone therapy. Now, with the results of a new phase 3 clinical trial, some oncologists believe a third option may soon be laid on the table: surgery with hormone therapy both before and after the operation.

The study, called the PROTEUS trial, found that combining two hormone therapies both before and after surgery was superior to just one hormone therapy before and after surgery in high risk, early stage prostate cases. 

There is a range in how prostate cancer experts are interpreting the results, however. Many told STAT that they believed it would lead to a new standard of care, with Emmanual Antonarakis, a genitourinary medical oncologist at the University of Minnesota, calling it a “watershed moment” in prostate cancer in a New England Journal of Medicine editorial.

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Imaging Technique Can Differentiate Lung Inflammation from Fibrosis

A type of computed tomography (CT) imaging known as SPECT (Single Photon Emission Computed Tomography) in combination with a new imaging agent could allow clinicians and researchers to visualize inflammation in the lungs to better target treatment to patients.

Interstitial lung disease includes over 200 conditions that scar and inflame the lungs. Researchers estimate around 650,000 people in the U.S. have this kind of lung disease and 50,000 new patients are diagnosed in the U.S. each year with interstitial pulmonary fibrosis (IPF) alone. The main problem with interstitial lung disease is that doctors currently cannot reliably tell inflammation from scarring without invasive diagnostic procedures.

In this Phase II study, presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Los Angeles, Druin Burch, consultant physician at John Radcliffe Hospital in Oxford, U.K., and colleagues tested whether a radioactive imaging agent, 99mTc-maraciclatide, injected into patients imaged with SPECT-CT could detect inflammation in the lungs.

“The molecular imaging agent 99mTc-maraciclatide binds to αvβ3 integrin, which is upregulated in vascular endothelial cells during angiogenesis, a cardinal feature of inflammation,” explain Burch and colleagues. “The agent has demonstrated diagnostic promise in other inflammatory conditions such as endometriosis.”

Overall, 15 people were scanned as part of the study: five healthy controls, five with IPF, and five with fibrotic hypersensitivity pneumonitis, which involves more active inflammation. The researchers found that those with fibrotic hypersensitivity pneumonitis had nearly double the inflammatory signal on imaging of healthy controls. Patients with IPF were somewhere between these two groups, which might be expected as IPF is known to be more fibrotic than inflammatory.

“While current imaging techniques can provide a structural view of fibrosis in the lungs, there is no reliable, non-invasive way to identify inflammation,” commented Burch in a press statement. “A tool that could detect inflammation in interstitial lung disease patients could help pinpoint those most likely to respond to anti-inflammatory therapy.”

To reach a wider group of patients a Phase III study is required to test the imaging agent in more people. 99mTc-maraciclatide has FDA Fast Track status for use in patients with interstitial lung disease, so if a larger study is successful it could be available to patients in less than five years.

“Being able to differentiate the fibrotic and inflammation stages of interstitial lung disease is not just beneficial to inform treatment decisions, but also for the development new therapies,” said Burch. “This approach has the potential to unlock a wide range of anti-inflammatory drugs.”

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STAT+: Practice-changing results reported for Revolution Medicines pancreatic cancer drug

CHICAGO — Rachna Shroff, a physician and pancreatic cancer expert, was seeing patients at the University of Arizona Cancer Center in April when she heard the striking clinical results about an experimental pill called daraxonrasib. Patients taking the targeted drug lived nearly twice as long as patients offered standard chemotherapy — an outcome never seen before in the pancreatic cancer field. 

“Having treated pancreatic cancer for 16 years, I actually started crying in the clinic,” Shroff said at a media briefing. “This is such an incredibly impactful study for our patients.”

On Sunday, detailed results from the daraxonrasib clinical trial conducted by the drug’s maker, the biotech company Revolution Medicines, were presented here at the plenary session of the annual meeting of the American Society of Clinical Oncology. The study was published simultaneously in the New England Journal of Medicine. 

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Teclistamab Outperforms Standard Therapy in Relapsed Multiple Myeloma

The treatment landscape for multiple myeloma has undergone a dramatic transformation over the past decade, driven by a growing arsenal of immunotherapies that harness the patient’s own immune system to fight cancer. Now, results from a large international Phase III trial suggest that one of the newest entrants to this class, the bispecific antibody teclistamab, may be poised to move even earlier in the treatment paradigm.

The findings, published in the New England Journal of Medicine and presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that teclistamab significantly improved progression-free survival and depth of response compared with standard therapies in patients with relapsed multiple myeloma.

The study represents one of the strongest demonstrations to date that chemotherapy-free immunotherapy can outperform conventional approaches even after only a limited number of prior treatments.

Moving bispecific antibodies earlier in treatment

Teclistamab belongs to a rapidly expanding class of therapies known as bispecific antibodies. Unlike traditional monoclonal antibodies, bispecifics are engineered to bind two targets simultaneously. Teclistamab recognizes both BCMA, a protein expressed on multiple myeloma cells, and CD3 on T cells, effectively bringing immune cells into direct contact with tumor cells and triggering targeted cancer cell killing.

The therapy has already shown substantial activity in heavily pretreated patients with advanced disease. However, investigators wanted to determine whether moving the drug earlier in the disease course could provide even greater benefit.

“Now we have chemotherapy-free immunotherapy options for patients whose myeloma has relapsed for the first time,” said C. Ola Landgren, MD, chief of the Sylvester Myeloma Institute and senior author of the study. “We are seeing very deep responses and long clinical benefit from these therapies. This is part of a much bigger transformation happening in myeloma care.”

Landmark global trial

The Phase III MajesTEC-9 trial enrolled 593 patients across 24 countries. Participants had relapsed multiple myeloma after one to three prior lines of therapy, representing a patient population increasingly encountered in routine clinical practice.

Approximately three-quarters of patients had already become refractory to commonly used treatments, including immunomodulatory drugs such as lenalidomide and anti-CD38 therapies such as daratumumab. These patients typically face diminishing treatment options and shorter durations of disease control.

Patients were randomized to receive either teclistamab or standard treatment regimens.

The results demonstrated a clear advantage for the bispecific antibody.

After 18 months of follow-up, nearly 70% of patients treated with teclistamab remained free from disease progression, compared with only about 27% of patients receiving standard therapies.

The magnitude of benefit exceeded what many clinicians have come to expect in relapsed myeloma, where treatment resistance often emerges rapidly.

Deep remissions become increasingly common

Beyond delaying disease progression, teclistamab produced remarkably deep responses.

Nearly two-thirds of treated patients achieved complete remission, meaning no evidence of disease could be detected using conventional testing methods.

Another highlight was the frequency of minimal residual disease (MRD) negativity, an increasingly important endpoint in multiple myeloma research. MRD testing uses highly sensitive techniques capable of detecting tiny numbers of remaining cancer cells that standard assessments might miss.

Many patients receiving teclistamab achieved MRD-negative status, suggesting that the therapy may be capable of driving deep eradication of disease.

“To see that this drug is so efficacious and so safe across patients from all these locations worldwide is a very strong signal,” Landgren said. “To see that in patients who have been exposed and refractory to commonly used myeloma treatments is very important.”

The broader shift away from chemotherapy

The results reflect a larger evolution occurring throughout multiple myeloma treatment.

For decades, chemotherapy served as the backbone of therapy. Today, however, treatment increasingly revolves around immune-based approaches including monoclonal antibodies, CAR T-cell therapies, and bispecific antibodies.

Researchers are not only developing new immunotherapies but also moving them earlier into treatment algorithms, where the immune system may be more intact and capable of mounting stronger anti-tumor responses.

The success of teclistamab in earlier-relapse patients supports this strategy and raises the possibility that bispecific antibodies could eventually become standard components of frontline treatment.

Managing infection risk remains critical

Despite the encouraging efficacy results, teclistamab is not without challenges.

Because the therapy activates T cells and alters immune function, infection remains one of the most important safety considerations. The risk is particularly pronounced during the first several months of treatment, when immune suppression can occur as part of the therapeutic response.

To mitigate this risk, patients typically receive antiviral and antibiotic prophylaxis, undergo routine monitoring of immunoglobulin levels, and may receive supplemental immunoglobulin infusions when necessary.

Investigators reported that these risks were manageable with appropriate monitoring and supportive care, consistent with previous studies of bispecific antibodies.

Looking toward curative strategies

The success of teclistamab is part of a broader effort to transform multiple myeloma from a chronic relapsing disease into one that can potentially be controlled for extended periods, or perhaps one day cured.

Researchers are already investigating whether teclistamab and related bispecific antibodies can be incorporated into even earlier treatment settings, including newly diagnosed disease.

“For me, the goal is to develop curative strategies,” Landgren said. “We are working toward treatments that can either eliminate the disease entirely or control it for very long periods while minimizing the burden on patients and preserving quality of life.”

As bispecific antibodies continue to demonstrate increasingly durable responses, the field is moving closer to that goal. The MajesTEC-9 results suggest that immune-based therapies are no longer merely alternatives to conventional treatment, they may be emerging as the new standard for many patients with relapsed multiple myeloma.

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Antibiotic Design Strategy Overcomes Efflux-Mediated Resistance in Preclinical Study

Researchers headed by a team at King’s College London have developed a new way of designing antibiotics that could support the discovery of new treatments for drug-resistant infections.

Designed to overcome one of the ways bacteria escape antibiotic treatment, the Efflux Resistance Breaker (ERB) approach allows researcher to chemically redesign antibiotics so that they are less easily removed from the cells by bacterial efflux pumps. The technology could also help revive antibiotics that have lost effectiveness due to the evolution of efflux-mediated resistance.

Study lead Professor Khondaker Miraz Rahman, PhD, a professor of medicinal chemistry at King’s College London, said: “Antimicrobial resistance is rising, but the number of truly new antibiotics in development remains worryingly low. Our work shows that we can redesign antibiotics so they stay inside bacterial cells at higher concentrations and overcome resistance mechanisms that would normally make them ineffective. This approach could help us design better new antibiotics, but it could also help revive existing antibiotic classes that bacteria have learned to defeat.”

Rahman is senior author of the team’s published paper in Journal of Medicinal Chemistry, titled “Designing Antibiotics with Inherent Resistance to Efflux as a Strategy to Revive Discovery against Multidrug-Resistant Pathogens.”

Worldwide increase in antimicrobial resistance (AMR) is threatening new developments in antibiotics, the authors noted. “The development and approval of new antibiotics are currently being outpaced by the emergence of resistance to existing drugs, a trend that must be reversed to ensure the long-term effectiveness of antibiotics.”

Many bacteria use molecular pumps, known as efflux pumps, to push antibiotics out of the cell before the drugs can reach levels high enough to kill them. This reduces the amount of antibiotic inside the bacteria and allows resistant infections to survive. Previous strategies have tried to combine antibiotics with separate efflux pump inhibitors (EPIs), the team continued. “Efflux pump inhibitors (EPIs) have been pursued as adjunct therapies to safeguard approved antibiotics prone to efflux-based resistance.” However, no EPI has yet been approved. “As well as a lack of mechanistic insight and biochemical information regarding efflux pumps, we opine that this failure is rooted in a fundamental flaw in the EPI-antibiotic combination approach: that the antibiotics remain unmodified substrates and can be effluxed by different pumps despite the presence of EPIs,” the authors noted.

The study by Rahman and colleagues has now shown that antibiotics can be chemically redesigned so they are less easily removed by these pumps. Their approach builds resistance-breaking properties directly into the antibiotic molecule, meaning that the antibiotic is designed to protect itself from being pumped out, allowing it to remain inside the bacterial cell at higher concentrations, and so restoring its ability to kill bacteria even when resistance mechanisms are present.

Importantly, the work shows that the ERB approach could support a new way of developing antibiotics by building resistance-breaking properties directly into their design. In their reported study the team developed ERB-modified fluoroquinolones and demonstrated their effectiveness against multiple bacterial pathogens, and in mouse infection models. The study provides an important proof of concept for antibiotic discovery, showing that maintaining high intracellular antibiotic concentration can help overcome resistance, including in bacteria that already show reduced susceptibility to existing antibiotics. “This study demonstrates that ERB modification enhances intracellular accumulation, reduces efflux susceptibility, and preserves antibacterial potency, as supported by complementary mechanistic, biochemical, and in vivo evidence,” the scientists concluded.

Added J. Mark Sutton, PhD, at the UK Health Security Agency, a key collaborator on this project, “Efflux pumps are a major cause of antibiotic resistance because they reduce the concentration of drug inside the bacterial cell. This study shows that rational chemical design can be used to overcome that problem. By building efflux resistance directly into the antibiotic, we may be able to restore activity against bacteria that are no longer controlled by current drugs.”

The researchers believe the ERB platform could be used as a general strategy to design antibiotics with built-in resilience to efflux-mediated resistance. Their team describes the ERB technology as a framework for developing next-generation antibiotics and for revitalizing existing drugs. “Beyond revitalizing existing drugs, ERB technology provides a general framework for designing next-generation antibiotics with built-in resilience to efflux-mediated resistance at the earliest stages of discovery,” they stated.

The team says it will work towards commercializing the ERB technology and advancing antibiotics developed using this strategy towards clinical development, with the aim of translating this discovery into new treatment options for drug-resistant infections.

The post Antibiotic Design Strategy Overcomes Efflux-Mediated Resistance in Preclinical Study appeared first on GEN – Genetic Engineering and Biotechnology News.

Sleep-related problems among patients with rheumatoid arthritis in the World Health Organization Eastern Mediterranean region: a systematic review and meta-analysis

BackgroundSleep-related problems are common among patients with rheumatoid arthritis (RA) and contribute substantially to disease burden and reduced quality of life. Evidence from the World Health Organization Eastern Mediterranean Region (WHO EMRO) remains fragmented, with variability in reported prevalence, sleep constructs assessed, and associated risk factors. This study aimed to systematically review and meta-analyze the prevalence and correlates of sleep-related problems among adults with RA in WHO EMRO countries.MethodsA systematic search of PubMed, Scopus, Web of Science, Embase, CINAHL, and Google Scholar was conducted to identify observational studies reporting sleep-related outcomes among adults (≥18 years) with RA in WHO EMRO countries from inception to 27 July 2025. Study screening, data extraction, and quality appraisal using Joanna Briggs Institute (JBI) checklists were conducted primarily by a single author, with methodological oversight and consultation from senior collaborators. Eligible studies reported prevalence or sufficient data to calculate prevalence of specific sleep-related constructs, including subjective sleep quality, insomnia symptoms, daytime sleepiness, or obstructive sleep apnea. Random-effects meta-analysis (DerSimonian-Laird) was used to pool prevalence estimates and odds ratios (ORs) for associated risk factors. Heterogeneity was assessed using the I² statistic and Cochran’s Q test. Subgroup analyses were conducted by sleep construct, assessment method, and country. Publication bias was evaluated using funnel plots, Egger’s test, and Begg’s test, with cautious interpretation due to the small number of studies.ResultsTen studies met inclusion criteria for qualitative synthesis, and six studies (n = 2,315 participants) were included in the quantitative meta-analysis. The pooled prevalence of sleep-related problems was 60.9% (95% CI: 56.5%–65.2%), with substantial heterogeneity (I² = 88%, p < 0.001), reflecting differences in sleep constructs and assessment methods. Subgroup analyses yielded pooled prevalence estimates of 58% for insomnia symptoms, 65% for obstructive sleep apnea-related measures, and 61% for poor subjective sleep quality (PSQI above cut-off), with no statistically significant differences between subgroups. Among associated factors, depression showed the strongest association with sleep-related problems (OR = 2.65; 95% CI: 1.87–3.75), followed by pain (OR = 2.18; 95% CI: 1.68–2.84), fatigue (OR = 1.91; 95% CI: 1.45–2.52), female gender (OR = 1.67; 95% CI: 1.25–2.23), and older age (OR = 1.42; 95% CI: 1.12–1.80). Heterogeneity for risk factor analyses ranged from low to moderate. Publication bias assessments did not indicate statistically significant small-study effects but were underpowered.ConclusionSleep-related problems—assessed using heterogeneous subjective and objective measures—are highly prevalent among patients with RA in WHO EMRO countries with available data. Given substantial clinical and methodological heterogeneity and the limited number of contributing countries, findings should be interpreted as reflecting overall sleep-related burden rather than the prevalence of a single clinical disorder. Routine screening, multidisciplinary management, and culturally adapted interventions are recommended. Future large-scale, longitudinal studies using standardized diagnostic criteria across a broader range of WHO EMRO countries are needed to strengthen the evidence base.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251109906, identifier CRD420251109906.

Antibody Drug Slows Disability Progression in Advanced Multiple Sclerosis

Results from the Phase III ORATORIO-HAND study show that ocrelizumab, an antibody drug already prescribed to some patients with multiple sclerosis (MS), could benefit a much larger patient population, including those who are older or at more advanced stages of the disease. Published today in The Lancet, these findings could change the way clinicians understand and manage MS. 

“Our study suggests we should think differently about what successful treatment looks like in advanced MS and that we shouldn’t assume a lack of benefit in certain groups,” said Gavin Giovannoni, MD, PhD, professor of neurology at Queen Mary University of London. “These findings show that treatment can make a meaningful difference to people with more advanced forms of MS and can help preserve hand and arm function, which is important for maintaining independence, daily activities and quality of life.” 

The clinical trial recruited over 1,000 patients with primary progressive multiple sclerosis (PPMS), a form of MS where disability worsens over time that affects about 10–15% of people diagnosed with the autoimmune condition. Ocrelizumab is currently available to patients early on in their PPMS with lower levels of disability, delivered as an infusion every six months to reduce disability progression. However, those with advanced disease, including patients who need a wheelchair to move around, are not eligible for this treatment and currently have limited options available to them. 

Compared to a placebo, ocrelizumab significantly reduced the risk of disability progression by 30%, with stronger effects in patients showing signs of inflammatory activity on MRI scans, for whom the drug reduced this risk by 55%. The treatment also reduced the worsening of hand and arm function by 41% after 12 weeks and lowered the need for a wheelchair by 52% among patients who were already unable to walk freely at the start.  

These results settle a longstanding debate over whether more advanced forms of multiple sclerosis can still benefit from treatment. In contrast with previous studies, which often excluded patients over 55 and those with advanced disability, this clinical trial recruited participants up to 65 years old and those with substantial mobility impairment. 

In addition to assessing walking ability, the study focused on assessing hand and arm function. This decision was based on a separate survey conducted by Giovannoni’s team in which patients with worsening multiple sclerosis reported prioritizing upper-limb function due to its importance for their independence, including their ability for cleaning and grooming themselves. 

“MS can be debilitating, exhausting and unpredictable, and hand and arm function is essential for helping people to remain independent,” said Catherine Godbold, PhD, senior research communications manager at the MS Society. “Many previous trials have focused solely on walking ability as a measure of whether a drug is effective. But trials like this are vital in helping us find treatments for everyone.”  

“Ocrelizumab is already used as a treatment for active relapsing MS and early primary progressive MS,” she added. “These results could mean it is made available for more people with primary progressive MS, who don’t currently have access to any treatment options. The key now is how we work together to see these findings translated into clinical practice.” 

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Hormone Cell Atlas Maps Body’s Chemical Messengers

An initiative to map hormones in the human body has revealed the breadth and complexity of the endocrine system and could deliver transformative insights into disease for the creation of new therapeutics.

The Hormone Cell Atlas provides a comprehensive framework to explore the impact of these chemical messengers in health and disease, combining a system-level overview with detail at a cellular level.

Its creation incorporates transcriptome-level data from dozens of tissue types and involves the expression of hundreds of hormone and receptor genes in millions of cells and nuclei.

The research, in Science, reveal the distributed and interconnected nature of hormonal regulation, involving a wide repertoire of cell types derived from multiple cell lineages.

These cells show the potential to both synthesize or modulate hormones, with most expressing receptor genes that may integrate signals from multiple hormones.

“These findings have implications not only for understanding physiology and its perturbation in disease, but also for understanding the pleiotropic effects of hormone-based therapies,” reported Lijiang Fei, PhD, from the University of Cambridge, and co-workers.

“For example, expression of GLP1R and GIPR in cardiomyocytes and cardiac pacemaker cells raises the possibility that any cardiovascular benefits or risks of these drugs may arise from direct receptor engagement, not solely from weight loss or improvements in glycemic control.”

Hormones are secreted by endocrine glands and act across tissues and organs to coordinate physiological functions, orchestrating metabolism, growth, reproduction, and other essential physiological processes using tightly regulated synthesis and release.

Inspired by the creation of the Human Cell Atlas, which aims to map all the cells in the human body, Fei and co-workers set out to improve understanding of the synthesis and action of hormones.

Using information from that initiative, the team analyzed the expression of 379 hormone and receptor genes in a transcriptomic dataset comprising 14 million single cells and nuclei across 47 human tissues.

The team mapped the cellular architecture of hormone production and action across diverse tissues and lineages, charted long-range endocrine feedback loops, and localized the expression of genes associated with monogenic endocrine and metabolic disease at cell type resolution across a variety of tissues.

Through this, they created a comprehensive, high-resolution, browsable map that predicted hormone production at cellular resolution.

“The atlas not only recovers classical endocrine axes but also illuminates underappreciated sites of hormone production and action,” the authors pointed out.

“We highlight important principles in endocrine biology, including local modulation of steroidogenic signals in peripheral tissues, specialized vascular-endocrine niches, and the role of adipocytes as dynamic hormone-producing and -sensing cell types.”

They conclude: “This accessible, adaptable resource establishes a dynamic framework for dissecting endocrine physiology and paves the way for mechanistic and physiological studies, which together may deliver transformative insights into human endocrine disease and inform rational drug discovery.”

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