EORTC shines a light on advancements in radioligand therapy

Brussels, Belgium, 8 October 2025 – EORTC is at the forefront of advancing cancer research, and one of the key areas of focus is Radioligand Therapy (RLT). On the occasion of the upcoming European Association of Nuclear Medicine (EANM) Congress (4-8 October 2025, Barcelona, Spain), where EORTC co-hosted a symposium, we are excited to highlight the significant strides being made by EORTC in this innovative field. 

The EANM and EORTC collaborate to advance cancer care by integrating nuclear medicine into clinical research. They leverage their combined expertise to design and run large, multidisciplinary clinical trials, especially in areas like radioligand therapy. This partnership is essential for establishing the robust clinical evidence needed to develop new standards of care and improve patient outcomes across Europe.

To further this partnership, EORTC & EANM co-hosted a symposium at the EANM Congress on Monday 6 October entitled “Oncology & Theranostics Committee / EORTC – Oncological Response Criteria for PET: beyond RECIST, EORTC & PERCIST”.

Check the programme here.

A cornerstone of EORTC’s commitment to RLT, this dedicated Task Force, chaired by Matthias Preusser & Christophe Deroose, was established to address the critical need for robust clinical evidence in this rapidly evolving field.

Its primary mission is to design and implement meaningful clinical trials using radioligands as theranostics-based approach, ensuring the generation of high-quality data to advance patient care. The Task Force also plays a crucial role in promoting standardisation and quality assurance within RLT research.

Learn more about the Task Force

• LUMEN-1 trial: improving patient outcomes recurrent meningioma

The RLT Task Force plays a crucial role in designing and implementing studies that aim to improve patient outcomes. A prime example of this dedication is the EORTC-2334-BTG LUMEN-1 clinical trial. This pivotal trial will evaluate the effectiveness of a new treatment strategy for meningioma called [177Lu]Lu-DOTATATE in patients with recurrent meningioma.

This treatment has shown promising results in smaller studies and is now being tested in a larger, randomised phase II trial involving 136 patients across 35 sites in 10 European countries.

You can also learn more by checking the publication of the protocol of LUMEN-1 in the Journal of Nuclear Medicine by Nathalie Albert et al.: https://pubmed.ncbi.nlm.nih.gov/40774695/

The study is supported by Advanced Accelerator Applications (a Novartis company).

• RENALUT: expanding the therapeutic landscape of renal cancer

Emmanuel Seront, study coordinator, introduces the Renalut study:

The EORTC-2361-GUCG RENALUT is a phase II, single-arm, multicentre trial led by EORTC. The objective of the trial is to evaluate the efficacy of [177Lu]Lu-PSMA-617 in second/third line metastatic clear cell renal cell carcinoma (ccRCC). The utilisation of [177Lu]Lu-PSMA-617, which targets PSMA (prostate-specific membrane antigen), has demonstrated both efficacy and safety in the treatment of metastatic prostate cancer. Although PSMA has been observed to be present on prostate tumour cells, the term is considered inappropriate due to its concomitant expression in neo vasculature and in other organs. Hypervascularization represents a significant consequence of the mutation of the Von Hippel-Lindau (VHL) gene, which is prevalent in cases of clear cell renal cell carcinoma (ccRCC). PSMA targeted imaging has been reported to demonstrate a high degree of accuracy in the evaluation of metastatic ccRCC, thus indicating its potential as a target for radioligand therapy.

The current standard of care involves the combination of a vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) and an immune checkpoint inhibitor (ICI). After progression on these regimens, the standard approach is sequential VEGFR-TKI therapy. Nevertheless, the efficacy is modest.

This innovative study introduces a novel therapeutic approach for aggressive disease, leveraging promising outcomes observed in prostate cancer and the known PSMA overexpression in ccRCC. RENALUT aims to expand the therapeutic landscape and provide new hope for patients with limited treatment options.

The study is supported by Advanced Accelerator Applications (a Novartis company).

• PEACE III: unlocking the potential of therapeutic radionuclides

The EORTC-1333-GUCG PEACE III phase III trial, which presented its late-breaking results at ESMO 2024 (European Society for Medical Oncology) on 14 September 2024 during a presidential symposium, is a landmark study demonstrating a significant improvement in patient outcomes for metastatic castration-resistant prostate cancer (mCRPC) patients with bone metastases.

The trial successfully showed that adding six cycles of the alpha-emitting radionuclide radium-223 (223RaCl2) to enzalutamide, an AR pathway inhibitor, increased median progression-free survival from 16 to 19 months, with an interim analysis also suggesting an overall survival advantage.

This groundbreaking study perfectly symbolises our work in nuclear medicine — specifically, using a targeted therapeutic radiopharmaceutical to provide effective, manageable, combination treatment—to meaningfully prolong life and establish a new standard of care in advanced cancer treatment.

The trial was a collaboration between EORTC, CTI CUOG, LACOG, and GETUG/UNICANCER, and also shows the importance of partnerships in clinical trials.

This trial is supported by an investigator driven clinical trial agreement from Bayer HealthCare Pharmaceuticals Inc. and Astellas Pharma Europe.

To conclude, EORTC’s work in radioligand therapy is highly representative of EORTC’s overarching multi-tumour approach to cancer research, leveraging the organisation’s unique multidisciplinary infrastructure. Its work is intrinsically linked to and supported by various EORTC Disease-Oriented Groups (e.g., Brain Tumour Group, Genito-Urinary Cancers Group) and transversal platforms, like the EORTC Imaging Group. This collaborative model ensures that the expertise in imaging and nuclear medicine is central to designing and executing studies across diverse cancer types.

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.