Sponsors: AstraZeneca
Not yet recruiting
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.
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.”
The post Imaging Technique Can Differentiate Lung Inflammation from Fibrosis appeared first on Inside Precision Medicine.
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.
Background: Geographical and economic barriers limit access to health care services in rural regions of Colombia. In San Vicente del Caguán, the lack of infrastructure and rehabilitation professionals forces patients to travel long distances. Asynchronous telerehabilitation using video broadcasting is a viable strategy to address these challenges. Objective: This study aims to design and validate a telerehabilitation model using asynchronous audiovisual content broadcasting for rural patients, evaluating functionality, usability, and clinical effectiveness. Methods: A 4-stage case study developed and validated the model in San Vicente del Caguán: (1) analysis of telemedicine experiences and video-based therapy; (2) solution design including telecommunications infrastructure (radio links and Wi-Fi), mobile app (HSRehabiAPP), and web platform (HSRehabiWEB); (3) fieldwork with 7 patients receiving physical, occupational, or speech therapy, evaluating functionality (11 criteria), usability (8 criteria), and content quality (5 criteria); and (4) results analysis. The infrastructure connected San Rafael Hospital with remote centers in Los Pozos and Tres Esquinas. Participants (aged 7-68 years) from urban and rural areas had conditions including stroke, shoulder injuries, knee pathologies, hypertension, and attention-deficit hyperactivity disorder. Results: All 7 patients achieved 100% compliance across functional, usability, and audiovisual content criteria. Functional evaluation covered login, navigation, therapy access, session viewing, exercise execution, pain assessment, therapist communication, and satisfaction surveys. Usability assessment evaluated initial access, content location, navigation comfort, instructional guidance, session organization, video playback, instruction clarity, and interface intuitiveness. Content criteria included exercise clarity, step-by-step instructions, visual quality, audio quality, and correct posture demonstration. Patients reported high satisfaction, noting reduced travel costs and time, family convenience, and effective outcomes. Offline functionality proved essential in areas with limited internet connectivity. Conclusions: The asynchronous audiovisual telerehabilitation model is an effective solution for improving access to rehabilitation services in rural areas. It successfully addressed geographical barriers and infrastructure limitations while maintaining clinical effectiveness across therapies. Implementation requires adequate technological infrastructure, user-friendly platforms with offline capabilities, and quality therapeutic content. Future work demands inclusive health policies, professional training, and research with larger sample sizes to assess long-term sustainability in diverse rural contexts.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/eba510aecc9c2ca2d8a859c04f88c558" />
Background: Recent research has found that concurrent intimate partner violence (IPV) experience (ie, victimization) and use (ie, perpetration) may be more common than experiencing or using IPV in isolation. Therefore, screening for IPV experience and use concurrently is needed to provide resources and connect patients to care. Objective: In this work, we explore how clinicians made decisions to use a screening protocol for IPV use and experience and their perceptions of how concurrent screening impacted patients, clinicians, and the health care system. Methods: We conducted qualitative interviews with 19 clinicians (18 women and 1 man) who participated in a 90-day pilot screening implementation initiative, in which they were asked to integrate screening for IPV use and experience concurrently into their daily practice. Most clinicians (17/19, 89.5%) had prior IPV-related training. Interviews focused on clinicians’ experiences implementing the screening tool and were analyzed using thematic analysis. Results: We identified four themes: (1) new screening implementation is challenging, (2) screening for IPV use and experience concurrently can be uncomfortable, (3) pivoting strategies can make screening easier, and (4) screening for IPV use and experience concurrently is impactful. Findings highlighted complexities of implementing new screening protocols, as clinicians spoke about the importance of screening for IPV use and experience concurrently, while pointing out barriers to integrating the screening protocol into their daily clinical routines. Clinicians made adaptations to the screening protocol and the screener itself to assist with adherence to screening efforts. Conclusions: Findings demonstrate the need for and importance of screening concurrently for IPV use and experience, while bringing awareness to difficulties with implementing any new screener. Findings underscore the importance of addressing barriers to increasing screening efforts for IPV use and experience concurrently through increased allotment for screening efforts. The results also highlight opportunities for pivoting strategies and ongoing training and education around managing concurrent IPV use and experience. Future research should explore how decreasing barriers to screening efforts and adaptations to screening practices impact decisions to screen, while also exploring clients’ perspectives on being screened for IPV use and experiences concurrently.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/8a6b79ffc3a4f4317e82782c1221e158" />
The Trump administration has released a sweeping proposal to overhaul the bedrock regulation for all federal grants, and in doing so is seeking to codify tighter political control of federally funded research.
The changes, laid out in a 400-plus-page document published this week, would deemphasize the role of peer review in determining what work to fund, limit the ability for scientists to use federal funds to publish their research or travel to conferences, and offer political appointees more latitude to terminate grants at will.
The suite of proposed changes aligns in many respects with policies the administration has attempted to implement through executive orders and one-off announcements, sometimes at individual agencies; if formalized, the revised regulation would be in effect across the government and put the regulatory authority of the White House behind it.
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.
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.”
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.
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 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.
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.
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.
The post Teclistamab Outperforms Standard Therapy in Relapsed Multiple Myeloma appeared first on Inside Precision Medicine.