Lutathera (lutetium Lu 177 dotatate) / Novartis - LARVOL DELTA

177Lu-DOTATATE versus high-dose long-acting octreotide for somatostatin receptor-positive advanced GEP-NETs: A multicenter, randomised, open-label, positive-controlled phase III study (ESMO Asia 2025) - P3 | "177Lu-DOTATATE had an acceptable safety profile in GEP-NETs pts with PFS improvement versus high-dose long-acting octreotide."

Clinical • Late-breaking abstract • Metastases • P3 data • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • SSTR

Status of therapeutic nuclear medicine in Argentina. (PubMed, Phys Med) - "The available nuclear medicine therapies in Argentina in 2021 were based mainly on [131I]sodium iodide, and [223Ra]RaCl2. In contrast, [90Y] microspheres, and [177Lu]Lu-DOTA-TATE treatments were scarcely implemented. Dosimetry calculations were rarely performed and were conducted in complicated cases of Differentiated Thyroid Carcinoma or [90Y] microsphere therapies."

Journal • Endocrine Disorders • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Efficacy and safety of peptide radionuclide therapy with 177Lu-DOTATATE in Japanese patients with advanced neuroendocrine neoplasm: a multicenter retrospective study (JON2203-N). (PubMed, J Gastroenterol) - "177Lu-DOTATATE demonstrated favorable efficacy and safety in Japanese patients, particularly for pancreatic and hindgut NENs, with symptomatic benefits in functional tumors."

Journal • Retrospective data • Endocrine Cancer • Hematological Disorders • Liver Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Phase I trial of M3814 (Peposertib) in combination with lutetium 177 DOTATATE for metastatic well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (ENETS 2026) - P1 | "The combination of oral peposertib with Lu-177 do - tatate is safe, a promising radiation sensitizer in NET patients, and should be investigated in larger randomized clinical trials."

Combination therapy • Metastases • P1 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Multi-center NCI-sponsored phase I study of triapine in combination with 177Lu-dotatate in patients with well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs) (ESMO 2025) - P1 | "Triapine (150 mg) is the RP2D. A randomized phase 2 trial (ETCTN 10558) comparing the combination to 177Lu-dotatate monotherapy is currently enrolling at 14 sites across the United States."

Clinical • Combination therapy • P1 data • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Revisiting the segmentation threshold for Lu-177 SPECT. (PubMed, Med Phys) - "An optimal 177Lu-specific threshold (∼50%) was derived and clinically validated, differing from the conventional 42% threshold used for 99mTc. The new threshold improved segmentation accuracy across different therapeutic radiopharmaceutical distributions."

Journal • Oncology

KKS-312: Adjuvant radioligand therapy in neuroendocrine tumors (clinicaltrialsregister.eu) - P2/3 | N=160 | Recruiting | Sponsor: Philipps-Universitaet Marburg | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Cytotoxic T-cell signatures underlie therapeutic response to 177Lu-DOTATATE plus pembrolizumab in well-differentiated gastroenteric neuroendocrine tumors (AACR 2026) - P2 | "Responding patients with epNET exhibited prominent clonal expansion and upregulation of cytotoxic genes. These findings highlight key differences in peripheral immune dynamics associated with treatment response in WD-NETs and may inform strategies to optimize combination therapy."

IO biomarker • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • CD4 • CD8 • GNLY • GZMH • NKG7

Radiomics on 177Lu-DOTATATE Posttreatment Scans: Feasibility, Preprocessing Optimization, and Planar-SPECT Comparison. (PubMed, J Nucl Med Technol) - "Correlations between features assessed using the 2 different scaling methods were weak for intensity-based features and strong for histogram-based and second-order features. Except for intensity-based features, radiomic features derived from WBS images were not comparable with those obtained from SPECT scans."

Journal • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

A phase 1 trial of M3814 (peposertib) in combination with lutetium 177 DOTATATE for metastatic well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (AACR 2026) - "Abstract is embargoed at this time."

Combination therapy • Metastases • P1 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Dynamic systemic immune modulation in metastatic neuroendocrine tumor (NET) patients treated with targeted alpha-emitter212Pb-DOTAMTATE AlphaMedix (AACR 2026) - "Data-driven characterization of treatment-associated transcriptional changes in peripheral immune cells underscores immune modulation associated with clinical response to radioligand therapy. The translational potential of whole-blood RNA liquid biopsy is demonstrated with Immuno-Pharmacodynamic profiling of patient response to radioligand therapy, and identification of immune-related biomarkers of clinical response."

Clinical • Metastases • Gastrointestinal Neuroendocrine Tumor • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • SSTR

[177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study. (ASCO-GI 2024) - P3 | "177Lu-DOTATATE significantly prolonged PFS and demonstrated a clinically meaningful ORR, compared with high-dose octreotide LAR, in pts with newly diagnosed advanced G2 and G3 GEP-NETs. Safety was in line with the established profile of 177Lu-DOTATATE. This is the first randomized study to demonstrate efficacy of RLT as 1L treatment in any malignancy and will change clinical practice."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent. (clinicaltrials.gov) - P1 | N=65 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Jun 2026 ➔ Dec 2025

Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Medical Management of Well-Differentiated Pancreatic Neuroendocrine Tumors: From Conventional Therapies to Emerging Strategies. (PubMed, J Clin Med) - "In patients with radiologic progression requiring systemic disease control, targeted agents such as everolimus and sunitinib represent established subsequent options, particularly when disease stabilization is the primary therapeutic goal. Peptide receptor radionuclide therapy with 177Lu-DOTATATE has demonstrated meaningful antitumor activity and is generally considered in patients with SSTR-positive tumors with progressive disease (Ki-67 ≥ 10%) or increasing tumor burdens, especially when tumor reduction is desirable. Combination cytotoxic chemotherapy, most notably the capecitabine-temozolomide (CAPTEM) regimen, remains an important consideration for patients with higher tumor burdens or more aggressive tumor biology. This review summarizes current evidence and provides a practical overview of treatment selection and sequencing for the systemic management of Grade 1-2 pancreatic neuroendocrine tumors, while also highlighting emerging therapeutic strategies, including..."

Journal • Review • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR • SSTR2

MRI and 18F-fluorothymidine PET-MR for the early evaluation of renal and bone marrow effects in 177Lu-DOTATATE therapy. (PubMed, Endocr Oncol) - "This finding was supported by decreased FLT uptake on 18F-FLT PET-MR, indicating decreased bone marrow cell proliferation. MRI can also identify renal effects associated with this therapy."

Journal • Hematological Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor

Anaplastic meningioma: A single-center retrospective analysis (Sarcoma-RC 2026) - "Systemic therapy was used in 65%, most often bevacizumab (57%), followed by vorinostat, everolimus, immunotherapy, and Lutathera. Legal entity responsible for the study Mayo Clinic. Funding Mayo Clinic."

IO biomarker • Retrospective data • Brain Cancer • Meningioma • Solid Tumor • CDKN2A • CDKN2B • TERT

An international study of factors affecting variability of dosimetry calculations, part 5: impact of segmentation methods. (PubMed, EJNMMI Phys) - "Segmentation significantly contributes to variability in absorbed dose estimates, particularly for lesions and for kidneys with anatomical complexities. Standardizing segmentation protocols and providing training on advanced segmentation methods are essential to reduce variability."

Journal

NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2027 ➔ Aug 2026 | Trial primary completion date: Jun 2027 ➔ Aug 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CHGA • PTEN • RB1 • SSTR2 • SYP • TP53

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: NYU Langone Health | Trial primary completion date: Jan 2026 ➔ Apr 2025

Trial primary completion date • Brain Cancer • Meningioma • Oncology • Solid Tumor • SSTR2

Radiopharmaceuticals: Status, Regulatory Landscape and Future Perspective. (PubMed, AAPS PharmSciTech) - "Recent approvals highlight this clinical momentum, including Copper-64/Copper-67, a chemically matched theranostic radionuclide pair that reduces chelator-related variability and streamlines diagnostic therapeutic supply chains, Lutetium Lu-177 dotatate, an FDA approved radioligand therapy, and Lutetium Lu-177 vipivotide tetraxetan, a prostate cancer targeted radioligand therapy illustrate the clinical momentum of this field, yet hurdles remain in large-scale isotope supply, formulation robustness, and regulatory harmonization. This review highlights key innovations in vector design, radionuclide production, and formulation; explores how artificial intelligence is transforming imaging and therapy planning; and clarifies the shifting regulatory landscape for clinical translation. By highlighting both current achievements and future research priorities, we provide a comprehensive framework by integrating productions challenges, formulation considerations, and regulatory..."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Radiopharmaceutical: An Update and Comparison of Preclinical Investigation Result of Alpha and Beta Emitter Radioisotope. (PubMed, Drug Des Devel Ther) - "For instance, noticeable breakthroughs have been made with the approval of targeted beta-emitting radiopharmaceuticals using agents such as Lutathera ([177Lu]Lu-DOTA-TATE) or Pluvicto ([177Lu]Lu-PSMA-617). From the perspective of targeted beta therapy, limited studies on terbium-161 have revealed that it is more potent than lutetium-177 with the same targeting molecules in the same animal models. It has been concluded that targeted alpha therapy is generally better than targeted beta therapy in many preclinical settings."

Journal • Preclinical • Review

Drug interactions involving therapeutic radiopharmaceuticals: a systematic review. (PubMed, EJNMMI Radiopharm Chem) - "Drug interactions with therapeutic radiopharmaceuticals remain underreported, yet they may have significant clinical consequences. Clinical radiopharmacy plays a key role in detecting and preventing these interactions. Radiopharmacists, through their expertise, can identify potential interactions, influence therapeutic decisions, and positively impact patient management. Their involvement throughout the care pathway is essential to ensure the safe and effective use of these innovative therapies. Nuclear medicine physicians should also be aware that such interactions can alter biodistribution, compromise therapeutic efficacy, and increase the risk of adverse effects."

Journal • Review

LuPARPed-HM-2024: Study in children and adolescents for the treatment of recurrent or relapsed solid tumours with the treatment of Lutathera combined with olaparib Proposed (clinicaltrialsregister.eu) - P1/2 | N=27 | Recruiting | Sponsor: Fundacion De investigacion De Hm Hospitales | Active, not recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • SSTR

Recommendations for selection, treatment, and follow-up in peptide receptor radionuclide therapy (PRRT) for neuroendocrine tumors: a Delphi consensus from the Galician Multidisciplinary Group on Neuroendocrine and Endocrine Tumors (GGNET). (PubMed, Clin Transl Oncol) - "This Delphi consensus provides pragmatic, multidisciplinary, and evidence-informed guidance to harmonize routine clinical practice in the use of PRRT for well-differentiated, SSTR-positive NETs. The proposed statements and the algorithm aim to harmonize practice across centers, reduce variability in care, enhance safety, and ultimately improve patient outcomes."

Journal • Endocrine Disorders • Gastrointestinal Neuroendocrine Tumor • Hematological Disorders • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR