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Introduction

MAESTRO-NASH is an ongoing 54-month, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy of resmetirom in patients with biopsy-confirmed MASH and fibrosis. 966 patients with biopsy-confirmed NASH were randomized 1:1:1 to resmetirom 80 mg, resmetirom 100 mg, or placebo once daily. Dual primary endpoints at Week 52 were achieved with both resmetirom 80 mg and 100 mg: NASH resolution with no worsening of fibrosis (NR) or ≥1-stage improvement in fibrosis with no worsening of NAS (FI). Both Week 52 liver biopsy endpoints, NR and FI, were achieved. Resmetirom was recently approved for the treatment of adult patients with noncirrhotic NASH and liver fibrosis consistent with F2 to F3 stages. Expert guidance recommends treatment with resmetirom based on staging fibrosis using Vibration-Controlled Transient Elastography (VCTE). EASL recommends stratifying patients using Fibrosis-4 Index (FIB-4). Most guidelines recommend using VCTE cutoffs lower than 10 to <15 kPa for treatment.

Aims & Methods

We assessed results from baseline noninvasive tests (FIB-4, VCTE) against biopsy results in MAESTRO-NASH to measure how well they diagnosed noncirrhotic patients with NASH (consistent
with F2-F3 stages at baseline). We assessed the utility of a lower VCTE cutoff (8.5 to <10 kPa) in capture of F2 and F3 patients who otherwise would be missed. Also evaluated was the addition of
MRE/MRI-PDFF or ELF to VCTE to assess diagnostic utility.

Results

FIB-4 poorly predicted patients in the non-cirrhotic fibrosis stages: F2 (60% patients fell into low-risk) and F3 (40% fell into low-risk). Including a lower cutoff of VCTE (8.5 to <10 kPa) captured
F1B (34% 8.5 to <10 kPa) and many F2 (25% 8.5 to <10 kPa) and F3 patients (19% 8.5 to <10 kPa). The addition of MRE/MRI-PDFF to VCTE increased diagnostic accuracy for F2/F3 to 68% and
F4 to 81%. The addition of the ELF to the VCTE suggested that a low ELF result paired with high VCTE may warrant a VCTE repeat.

Conclusion

Identification of patients with NASH F2 to F3 was achieved with VCTE. F1B are F2 equivalent (F1B is moderate fibrosis on biopsy). Patients with fibrosis stage F4 were effectively ruled out. In addition to VCTE, practitioners may consider expanded noninvasive criteria (ELF, MRE) to help refine fibrosis staging.

Disclosure

This study was supported by Madrigal Pharmaceuticals, Inc.

USE OF NONINVASIVE TESTS (NITS) TO DIAGNOSE AND FOLLOW METABOLIC DYSFUNCTION ASSOCIATED STEATOHEPATITIS (MASH) WITH LIVER FIBROSIS PATIENTS TREATED WITH RESMETIROM

Jörn Schattenberg 1

1 Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg, Germany

Conference

UEG Week Berlin 2025

Topics

Hepatobiliary

Submission format

Abstract

Session

MASH: Screening, monitoring and treatment (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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AN IMMUNE RESPONSIVE TUMOR MICROENVIRONMENT IMPRINTS INTO PBMCS AND ALLOWS TO PREDICT PATIENT OUTCOME USING MACHINE LEARNING IN ADVANCED PANCREATIC CANCER: LESSONS FROM THE PREDICT TRIAL

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Introduction

Prognosis in advanced pancreatic ductal adenocarcinoma (aPDAC) is particularly poor. Few patients benefit from second-line chemotherapy, while most experience side effects, highlighting the need for biomarkers. The PREDICT trial examined in aPDAC patients whether first-line time-to-treatment failure (TTF1) predicts second-line treatment failure (TTF2) but found no association. In our translational study we hypothesized that the responsiveness of the tumor immune microenvironment (TiME) might determine second-line therapy outcome and examined whether treatment-naive tissue immune features are also reflected in the peripheral blood after one line of chemotherapy.

Aims & Methods

In the PREDICT trial, patients received 5-FU/LV plus nanoliposomal irinotecan second-line after gemcitabine/nab-paclitaxel (Gem-nabPac) first-line therapy. We stratified PREDICT patients by shortest vs. longest TTF2. Treatment-naive primary tumor tissues from 20 patients were analyzed by NanoString transcriptomic profiling and multiplexed immunohistochemistry to characterize differences in the TiME. Peripheral blood mononuclear cells (PBMCs) were obtained immediately before second-line therapy from 82 patients and analyzed using multiparameter flow cytometry with an automated gating procedure and gene expression profiling via RT-qPCR. A feature selection and machine learning pipeline integrated PBMC and clinical data to derive a minimal predictor for TTF2 outcome and prognosis that was validated across different treatment regimens on an independent external cohort of 30 patients with aPDAC.

Results

Treatment-naive tumors of patients in the long-TTF2 group exhibited an immune-active (“hot”) TiME with CXCR3⁺CD8⁺ cytotoxic T cell infiltration into the cancer cell compartment via CXCR3-dependant inflammatory chemokine signaling. Analysis of PBMCs obtained directly before second-line therapy showed that these immune features were sustained over one line of treatment and reflected in PBMCs. A PBMC-based machine learning model (“TTF2Pred”) identified a 7-feature immune signature that accurately distinguished long vs. short TTF2 patient groups outperforming multivariate clinical data or CA19-9 benchmark models. TTF2Pred robustness was confirmed by external validation and showed the best overall performance post-Gem-nabPac first-line treatment. Among the seven TTF2Pred features, long-TTF2 patients exhibited more circulating CXCR3⁺ activated T cells and plasmacytoid dendritic cells, while short-TTF2 patients had more circulating platelet–leukocyte (platelet-monocyte, platelet-neutrophil) aggregates and exhausted T cells.

Conclusion

PDAC patients with an immune-active, treatment-naïve TiME have a better outcome on second-line therapy, and these tissue characteristics are reflected in circulating PBMCs after one line of chemotherapy. A parsimonious circulating PBMC-based signature offers a minimally invasive predictor of second-line outcome that could inform personalized therapy.

AN IMMUNE RESPONSIVE TUMOR MICROENVIRONMENT IMPRINTS INTO PBMCS AND ALLOWS TO PREDICT PATIENT OUTCOME USING MACHINE LEARNING IN ADVANCED PANCREATIC CANCER: LESSONS FROM THE PREDICT TRIAL

Anton Lahusen 1, Manfred P. Lutz 2, Rui Fang 3, Martina Kirchner 4, Sarah Wisser 5, Klaus Kluck 4, Meinolf Karthaus 6, Andreas Schwarzer 7, Gabriele Siegler 8, Thomas J. Ettrich 1, Alexander Becher 1, Sabine Hoefling 9, Jens T. Siveke 3, Jan Budczies 4, Andrea Tannapfel 5, Albrecht Stenzinger 4, Phyllis Fung-Yi Cheung 3, Tim Eiseler 1, Thomas Seufferlein 1

1 University Hospital Ulm, Ulm, Germany

2 Caritas Klinikum Saarbrücken St. Theresia, Saarbrücken, Germany

3 University Hospital Essen, Essen, Germany

4 Heidelberg University Hospital, Heidelberg, Germany

5 Ruhr University, Bochum, Germany

6 München Klinik Harlaching and Neuperlach, München, Germany

7 Onkopraxis Probstheida, Leipzig, Germany

8 Klinikum Nürnberg Nord/Paracelsus Medizinische Privatuniversität, Nürnberg, Germany

9 CROLLL GmbH, Nürnberg, Germany

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Immunology Pancreas Surgery

Submission format

Abstract

Session

PDAC surveillance and treatment: The how's and why's

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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POLYDEEP ADVANCE 3: MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING THE POLYDEEP-ASSISTED COLONOSCOPY WITH CONVENTIONAL COLONOSCOPY

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Introduction

Computer-aided diagnosis (CAD) systems are widely implemented in the medical field for the analysis of medical images. PolyDeep is a CAD system that has demonstrated its efficacy in lesion detection.

Aims & Methods

The aim of this study is to determine whether PolyDeep increases the adenoma detection rate (ADR) in the context of expert endoscopists participating in a regional, population-based colorectal cancer screening program in Spain. PolyDeep Advance 3 (NCT05513261) is a multicentric, randomized controlled clinical trial. For the primary endpoint, we aimed to assess whether the ADR is superior in PolyDeep-assisted colonoscopy compared to conventional colonoscopy. As secondary endpoints, we aimed to determine whether PolyDeep-assisted colonoscopy improves the polyp detection rate (PDR), serrated lesion detection rate (SLDR), advanced serrated lesion detection rate (ASLDR), and advanced adenoma detection rate (AADR). We included participants who underwent colonoscopy for screening (i.e. those with a positive faecal immunochemical occult blood test – FIT+) or for surveillance after resection of advanced adenomas. We compared both groups using the chi-square and t-Student test.

Results

Between November 2023 and May 2024, we recruited 857 patients, of whom 30 were excluded. The baseline characteristics of the 827 patients included in the analysis were similar (male: 59.3%, screening colonoscopy: 66.7%, mean age: 61.7 ± 6.5 years, withdrawal time: 10:49 ± 04:32 minutes, colorectal cancer incidence: 2.8%). However, there were significant differences between both groups in the Boston Bowel Preparation Scale (conventional colonoscopy: 7.7 ± 1.3 vs. PolyDeep-assisted colonoscopy: 7.4 ± 1.3, p = 0.01). Regarding ADR, we did not find statistically significant differences between conventional and PolyDeep-assisted colonoscopy (57.7% vs. 60.8%, p = 0.4). Similarly, for the secondary endpoints, there were no significant differences in PDR (68.7% vs. 69.6%, p = 0.8), SLDR (32.0% vs. 29.4%, p = 0.5), ASLDR (5.3% vs. 5.1%, p = 1.0), or AADR (24.5% vs. 23.6%, p = 0.8). In Table 1, we described lesion detection rates between both groups by indication (i.e., FIT+ or surveillance).

	Screening		p	Surveillance		p
	Conventional colonoscopy	Assisted colonoscopy	p	Conventional colonoscopy	Assisted colonoscopy	p
ADR	61.8%	65.4%	0.4	50.0%	51.1%	0.9
PDR	72.1%	72.1%	1.0	62.5%	64.1%	0.9
SLDR	30.5%	28.2%	0.6	34.7%	32.1%	0.7
ASLDR	5.9%	6.8%	0.8	4.2%	1.5%	0.3
AADR	34.6%	32.1%	0.6	5.6%	5.3%	1.0

Table 1: Lesion detection rates in both groups by indication.

Conclusion

In the context of expert endoscopists PolyDeep did not increase the ADR.

POLYDEEP ADVANCE 3: MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING THE POLYDEEP-ASSISTED COLONOSCOPY WITH CONVENTIONAL COLONOSCOPY

Pedro Davila-Piñón 1, Astrid Irene Díez Martín 1, Cristina Regueiro Expósito 1, Alba Nogueira-Rodríguez 2, Florentino Fdez-Riverola 2, Miguel Reboiro-Jato 2, Daniel Glez-Peña 2, Rubén Domínguez-Carbajales 3, Luisa De Castro Parga 4, Jesús Daniel Fernández de Castro 5, Pablo Vega 5, Miguel Telmo Galovart Araguas 4, Santiago Soto 5, Sara Alonso Lorenzo 4, Alfonso Martinez Turnes 4, Noel Pin Vieito 5, Sara Zarraquiños Martínez 5, David Remedios 5, Cristina Alejandra Sánchez Gómez 5, Raquel Souto Rodríguez 6, Franco Baiocchi 5, María José Iglesias-Varela 5, Coral Tejido Sandoval 5, Alejandro Ledo 6, Laura Rivas Moral 5, Natalia Garcia Morales 4, Antonio Rodríguez 4, Manuel Puga 5, María Belén Castiñeira-Domínguez 6, Nereida Fernández Fernández 4, Arantxa Germade-Martínez 4, Enrique González 6, Indhira Miosotis 6, Romina Fernández Poceiro 4, Eloy Sanchez Hernandez 5, Hugo López-Fernández 2, Joaquín Cubiella 7

1 Research Group in Gastrointestinal Oncology, Ourense, Spain|||Galicia-Sur Public Biomedical Foundation, Ourense, Spain

2 Universidade de Vigo, Ourense, Spain|||SING Research Group, Ourense, Spain

3 Complexo Hospitalario Universitario de Ourense, Ourense, Spain

4 Hospital Álvaro Cunqueiro de Vigo - CHUVI, Vigo, Spain

5 Hospital Universitario de Ourense, Ourense, Spain

6 Hospital Montecelo - CHUP, Pontevedra, Spain

7 Research Group in Gastrointestinal Oncology, Ourense, Spain|||Hospital Universitario de Ourense, Ourense, Spain

Event

UEG Week Berlin 2025

Topics

Endoscopy Colorectal

Submission format

Abstract

Session

Detecting polyps with the help of AI

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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... for medical therapy in colorectal cancer

Sebastian Foersch 1

1 University Medical Center Mainz, Mainz, Germany

Event

UEG Week Berlin 2025

Topics

Colorectal IBD Surgery

Session

Predicting patient outcomes...

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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NOVEL BIOLOGICAL AND RADIOLOGICAL MARKERS FOR PREDICTING MALIGNANT PROGRESSION IN INTRADUCTAL PAPILLARY MUCINOUS NEOPLAMS: A PROSPECTIVE STUDY

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Introduction

Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas are the most frequently identified precursor lesions of pancreatic cancer (PDAC). Only a minority progress towards malignancy, making their identification a critical point in cancer prevention. The available guidelines are imprecise, commonly resulting in over treatment of indolent lesions.

Aims & Methods

The aim of this study (EMI-IPMN, NCT06706700) is to discover novel biological and radiological biomarkers that can distinguish malignant from benign IPMNs. We focused on Endocrine, Metabolic and Inflammatory (EMI) factors, some pathways that are characterized in PDAC but poorly investigated in IPMN progression.
Patients with a presumed diagnosis of IPMN with indication for surgical resection who underwent high-quality magnetic resonance imaging (MRI) and/or computed tomography (CT), were prospectively enrolled. Peripheral blood (PB) and cyst fluid (CF) samples were collected during surgery, and lesions were histologically classified as IPMN with low-grade dysplasia (LGD), high-grade dysplasia (HGD), or invasive cancer (IC). Malignant IPMNs were defined as those with HGD and IC. Cytokine and hormone levels were measured in both fluids using multiplex assays and compared across the diagnostic groups. Continuous variables were converted into categorical variables based on optimal cut-off values, and both univariate and multivariate logistic regression analyses were conducted.

Results

Among the 205 patients enrolled, 133 (58 females, 75 males, median age 69.2) had a histological diagnosis of IPMN: 49 (36.8%) had LGD, 44 (33.1%) HGD and 40 (30.1%) had IC. Analysis of the EMI profile revealed higher concentrations of several markers (IL-8, VEGF, GLP-1, glucagon, and C-peptide) in CF compared to PB. Specific cytokines such as MCP-1 IP-10, TNFα, and IL-8 were significantly elevated in the CF of HGD/IC cases compared to LGD (p=0.05, 0.041, 0.001 and 0.025 respectively). Similarly, IP-10, IL-8, and MDC levels in PB were higher in HGD/IC patients (p=0.006, 0.008 and 0.004 respectively).
Pancreatic fat content, assessed with mDixon Quant Fat Fraction MRI sequences, was notably higher in HGD/IC patients (13.89%) compared to LGD patients (8.38%, p<0.05), and positively correlated with MCP-1 levels in CF.
Among these biological and radiological markers TNFα in the CF demonstrated a substantial diagnostic accuracy for identifying malignant IPMN, with an area under the ROC curve (AUC) of 0.72. In the final multivariable analysis we demonstrate that high TNFα levels in CF and HbA1c were the two independent risk factors for the identification of malignant IPMN (OR 10.8 and 1.11 respectively).

Conclusion

The progression of IPMN to PDAC is associated with a proinflammatory shift in the tumor microenvironment, reflected by local (CF) and systemic (PB) elevations in key cytokines (TNFα, MCP-1, and IL-8) whose involvement in PDAC progression is well established. Elevated hormone levels in CF, along with the strong association between malignant IPMN and HbA1c, underscore the critical role of endocrine alterations in the early stages of pancreatic tumorigenesis. These findings may be harnessed to enable earlier detection of malignant transformation in IPMN. Moreover, the correlation between imaging markers and biological profiles suggests that MRI could serve as non-invasive proxies for underlying pathological changes. Together, these results offer new insights into the pathophysiology of IPMN progression and may imporve diagnostic strategies