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Phase 2 Trial Reports Pre-Surgery Responses to Colon Cancer Immunotherapy

In the phase 2 UNICORN trial, botensilimab plus balstilimab produced major pathological responses in 36% of pMMR and 100% of dMMR colon cancer cohorts before surgery. The small, non-randomized study provides an early clinical signal rather than a treatment comparison.

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Phase 2 lung cancer trial tests durvalumab before surgery or chemoradiotherapy

In the single-arm MDT-BRIDGE phase 2 study, 142 people with resectable or borderline resectable non-small-cell lung cancer received durvalumab plus chemotherapy before multidisciplinary teams directed them to surgery or chemoradiotherapy. Surgery was performed in 74.6%; survival follow-up is still early.

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Preprint finds surrogate endpoints dominate US cancer-drug approvals

A medRxiv analysis of 354 FDA oncology approvals from 2014 through early 2025 found surrogate endpoints had become the dominant primary measure used for approval. The authors also reported different relationships between surrogate-endpoint benefits and overall survival for immunotherapy and non-immunotherapy approvals.

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Five-year melanoma trial finds continued benefit from relatlimab–nivolumab

A prespecified five-year analysis of RELATIVITY-047 found lower hazards of progression and death with relatlimab plus nivolumab than with nivolumab alone. Exploratory biomarker analyses also linked higher LAG-3-positive CD8 cell levels to worse outcomes on nivolumab in a defined subgroup.

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Camupepimut misses primary endpoint in phase 2 pancreatic cancer trial

In the randomized AMPLIFY-7P phase 2 trial, camupepimut did not significantly improve disease-free survival across all participants after pancreatic cancer surgery. Prespecified subgroup analyses and immune-response findings provide signals for testing in a larger trial.

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Recent-infection testing could reduce TB vaccine-trial enrolment needs

A statistical model estimated that testing for recent tuberculosis infection could reduce the median number of people needed for a vaccine trial by 4.2- to 6-fold compared with long-lasting IGRA positivity under favourable conditions. The estimates are preprint model results, and the authors say candidate tests still need to be characterised.

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HER2-positive in 7.7% of screened ESCC cases in Danish study

A Danish nationwide screening effort found conventional HER2-positive status in 62 of 806 people with esophageal squamous cell carcinoma. In a small phase II trial, trastuzumab-based treatment showed responses, while tissue mapping found HER2-poor fibrotic areas enriched for B7-H3.

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Trial eligibility can make genetic scores appear to predict treatment response

A medRxiv preprint reports that trial eligibility criteria can create apparent differences in lipid-lowering treatment response by polygenic risk score, even when the true genetic interaction is set to zero. Its cohort analyses found little evidence that coronary artery disease risk scores modified statin effects.

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Phase 1 Trial Tests EGFR-Targeted Toxin in Recurrent Glioma

A single-site phase 1 trial evaluated D2C7-ATC, an EGFR-targeted antibody-toxin conjugate, in recurrent malignant glioma. Among 72 patients with IDH-wild-type recurrent glioblastoma, median overall survival was 7.9 months.

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PanChol booster study finds antibody seroconversion in 15 of 20 adults

In a phase 1a study of 20 healthy adults, 15 developed a fourfold rise in antibody titres against both cholera serotypes after a second PanChol dose. The preprint also reports reduced vaccine shedding after the booster, an indirect measure of intestinal immunity rather than a measure of protection from cholera illness.

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Talazoparib Plus Enzalutamide Shows No Clear Extra Benefit in Prostate Cancer Trial

In a randomized phase 2 trial of 54 men with high-volume metastatic hormone-naive prostate cancer, talazoparib plus enzalutamide produced a high PSA response rate but no clear advantage over enzalutamide alone. Severe adverse events were more frequent with the combination, and two patients developed fatal acute myeloid leukaemia.

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In-vivo BCMA CAR-T follow-up finds one 15-month remission

A phase 1 follow-up of four patients with relapsed or refractory multiple myeloma found that one maintained a stringent complete response for 15 months. The other three progressed within five months, and median progression-free survival was 4.0 months.

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A 52-week semaglutide trial examines kidney effects in diabetes

In the 52-week REMODEL trial, semaglutide was associated with changes in kidney vascular measures and tissue signals in people with type 2 diabetes and chronic kidney disease. The three coprimary MRI outcomes did not differ significantly from placebo.

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technology

Wearables enter clinical trials, but validation still limits adoption

Wearable devices are increasingly being used in clinical trials to collect continuous physiological data outside research centres. Their broader adoption depends on measurement accuracy, technical reliability, meaningful clinical endpoints and responsible data governance.