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

Pancreatic Neuroendocrine Tumor With Liver and Lung Metastases (ATS 2025) - "Discussion : While the estimated incidence rate of PNETs is less than 1 case in every 100,000 individuals per year, the Surveillance, Epidemiology and End Results (SEER) program demonstrated an increased incidence in the United States from 0.17 to 0.47 per 100,000 people within a span of 3 decades. In essence, this case draws attention to the challenges in managing metastatic PNET treated with target radiation therapies such as Lutathera and issues a clarion call for advancement of treatment modalities of a rare malignancy with steadily increasing occurrences."

Cholestasis • Endocrine Cancer • Hepatology • Infectious Disease • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Septic Shock • Solid Tumor • GAST

Acute Respiratory Failure Following Initiation of Lutetium Lu 177 Dotatate (ATS 2025) - "This abstract is funded by: None Introduction: Lutetium Lu 177 dotatate (Lu-177) is a peptide receptor radionuclide therapy (PRRT) that is used in the treatment of neuroendocrine tumors (NETs). Retrospective analysis of everolimus induced pneumonitis report a median onset of symptoms of 3.6 months, however our patient tolerated this medication for over 9 years and it was discontinued prior to starting Lu-177. Overall, the timing of the patient's illness and the rapid response to treatment favors a reaction to Lu-177 rather than pneumonitis due to everolimus."

Cardiovascular • Endocrine Cancer • Fatigue • Immunology • Infectious Disease • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Pneumonia • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

Lutathera - withdrawal of application for variation to marketing authorisation (European Medicines Agency) - "Advanced Accelerator Applications withdrew its application for the use of Lutathera in the treatment of adults with newly diagnosed tumours in the gut, known as gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs). The company withdrew the application on 9 May 2025."

European regulatory • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

NETTER-P: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs (clinicaltrials.gov) - P2 | N=11 | Active, not recruiting | Sponsor: Advanced Accelerator Applications | Trial completion date: May 2029 ➔ May 2034

Trial completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Radiation absorbed dose efficacy of 177Lu-DOTATATE in radionuclide therapy of neuroendocrine tumors: a hybrid study of patient and simulation. (PubMed, Radiat Prot Dosimetry) - "The mean absorbed doses from the GATE were 0.076, 0.20, 0.29, and 0.47 mGy/MBq for the liver, kidneys, spleen, and tumors, respectively. Assessment of the results obtained from the GATE code as a voxel-level dose calculation tool in non-uniform media showed that 177Lu-DOTATATE may provide beneficial therapeutic effects."

Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Real world outcome analysis of the two McGill University–associated hospitals with Lu-177 PRRT for metastatic NET. (ASCO 2025) - "Despite the benefits in PFS, response rates and likely OS as a result of the use of Lutathera, its implementation in wider clinical practice outside the established PRRT centres in Europe and the US has been rather slow due to difficulties with acquisition of Dotatate imaging and subsequent treatment, as only certain specialized centres have experience and access to the required resources...Survival/progression free survival estimates were computed using the Kaplan-Meier method. Potential association between variables was measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests."

Clinical • Metastases • Real-world • Real-world evidence • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

iPRRT: Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Weill Medical College of Cornell University | Suspended ➔ Recruiting

Enrollment open • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • SSTR

Peptide receptor radionuclide therapy (Lu-177 PRRT) in neuroendocrine tumors (NET): Single institution experience over 15 years. (ASCO 2025) - "Treatment with Lu177-Dotatate PRRT therapy results in superior progression-free survival and overall survival and a significantly higher response rate than high-dose octreotide LAR.This study aims to report the efficacy of PRRT in NET cases treated at King Faisal Specialist Hospital and Research Center (KFSHRC) in Saudi Arabia This retrospective analysis included patients with unresectable, well-differentiated NETs who received PRRT between 2008 and 2022. Lu177-Dotatate PRRT is an effective treatment for well-differentiated NETs, demonstrating consistent efficacy across various subgroups, regardless of WHO grade, Ki67 index, or primary tumor site. This study, conducted at a single institution in Saudi Arabia, reinforces the role of PRRT in improving survival outcomes for NET patients, both as a first-line option after SSA therapy and in later lines of treatment. Results align with international data, supporting its broad applicability"

Clinical • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

A phase 2 study of lanreotide as a therapy for pheochromocytomas (PCs) and paragangliomas (PGs). (ASCO 2025) - P2 | " Conducted clinical trial to assess efficacy/toxicity of Somatuline Depot / Lanreotide Autogel every 4 weeks in patients with advanced/metastatic PC/PG. These data demonstrate efficacy for lanreotide in the treatment of PC/PG comparable to that previously found in NETs with prolonged disease stability the primary outcome. Given emerging data with PC and PG reports limited efficacy for Lutathera with meaningful toxicity, these data with lanreotide achieving a longer median PFS support a management strategy for PC/PG similar to that employed with NETs. Begin with a SSTR antagonist, extract its benefit and delay Lutathera administration until meaningful, consistent disease progression is documented."

P2 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

NCI 10479: A phase I dose escalation-expansion trial of sunitinib malate plus lutetium (Lu-177) dotatate in somatostatin receptor positive pancreatic neuroendocrine tumors. (ASCO 2025) - P1 | "Enrollment is ongoing. Clinical trial information: NCT05687123."

P1 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

A multi-centre, stratified, open, randomized, comparator-controlled, parallel group phase II trial comparing adjuvant treatment with 177Lu-DOTATATE to standard of care in patients after resection of neuroendocrine liver metastases (NELMAS). (ASCO 2025) - P2 | "Follow-up data will be collected for 5 years overall from the date of randomisation of the last patient. The NELMAS trial aims to investigate the efficacy of adjuvant therapy with 177Lu-DOTATATE (2 cycles) compared to standard of care in preventing tumour recurrence in patients following R0/R1 resection of LM of well differentiated GEP NET."

Clinical • P2 data • Endocrine Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Radioimmunotherapy-associated myeloid neoplasms: Real-world multicenter retrospective study using TriNetX database. (ASCO 2025) - "This study aims to investigate the risk of t-MNs following treatment with Lutathera (177Lu-DOTATATE) and Pluvicto (177Lu-PSMA-617) in patients with neuroendocrine tumors and metastatic castration-resistant prostate cancer. This is the largest study reporting the incidence of t-MN associated with RIT. Our study demonstrated a significant risk of therapy-related t-MNs following RIT, even in patients who did not receive additional chemoradiotherapy. Given the short follow-up, we hypothesize that the risk may increase with longer-term follow-up."

IO biomarker • Real-world • Real-world evidence • Retrospective data • Acute Myelogenous Leukemia • Castration-Resistant Prostate Cancer • Endocrine Cancer • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Solid Tumor

Outcomes with 177 lutetium-dotatate (177Lu-dotatate) in olfactory neuroblastoma (ONB): A case series. (ASCO 2025) - "Prior therapies included somatostatin analogues (n=4), chemotherapy plus PD-L1 inhibitor (n=1), Lenvatinib (n=1), and clinical trials with experimental drugs (n=3). 177Lu-dotate demonstrates activity in R/M ONB, with a favorable PFS compared to previously administered lines of systemic therapy. This case series, the largest reported to date to our knowledge, supports the growing evidence supporting for the use of 177Lu-dotate in this orphan disease."

Clinical • Endocrine Cancer • Neuroblastoma • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

Can 177Lu-DOTATATE Kidney Absorbed Doses be Predicted from Pretherapy SSTR PET? Findings from Multicenter Data. (PubMed, J Nucl Med) - "The prediction model achieved a mean relative absolute error 28% or less for both external and internal validation of PET-predicted absorbed doses. The intercenter differences suggest the need for standardized imaging protocols and dosimetry workflows."

Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Establishing In Vitro Dosimetric Models and Dose-Effect Relationships for 177Lu-DOTATATE in Neuroendocrine Tumors. (PubMed, J Nucl Med) - " PRRT requires on average an absorbed dose 3 times higher than EBRT to achieve equivalent effects in vitro. Traditional dosimetry overestimates the relative biologic effectiveness by underestimating the absorbed dose."

Journal • Preclinical • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Clinical Outcomes of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Skeletal Metastases from Neuroendocrine Tumors: Insights from Real-World Experience. (PubMed, J Nucl Med) - "Serum alkaline phosphatase monitoring is essential in this patient cohort. Achieving an optimal cumulative activity is crucial to maximizing the survival benefit of patients receiving PRRT."

Clinical data • Journal • Real-world evidence • Endocrine Cancer • Hematological Disorders • Leukopenia • Musculoskeletal Pain • Neuroendocrine Tumor • Neutropenia • Oncology • Pain • Solid Tumor • Thrombocytopenia

Removal of 177Lu radiotherapy drugs from Public Waste streams (SNMMI 2025) - "The radio-TLC showed that Pluvicto remained at the origin, while minimal movement was observed for Lutathera (Rf = 0.1). This was as expected based on literature and ensured that minimal elution occurs when subjected to urine as an eluant. After passing the radiopharmaceutical through the column, the total activity remaining on the column was 98% and 92% for Pluvicto and Lutathera, respectively."

Oncology

First-in-class Actinium-225 (Ac-225) antibody radioconjugate ATNM-400 exhibits potent anti-tumor activity in preclinical solid tumor models (SNMMI 2025) - "Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) and Lutathera® (lutetium Lu 177 dotatate), both FDA-approved beta-emitting therapies, have demonstrated efficacy in metastatic prostate cancer and gastroenteropancreatic neuroendocrine tumors, respectively, highlighting the potential of TR in addressing unmet clinical needs. ATNM-400 demonstrated robust anti-tumor efficacy in multiple preclinical models of solid tumors, supporting its potential as a novel therapeutic option for patients with limited treatment options or resistant to current targeted therapies. These findings underscore the promise of ATNM-400 for clinical translation and its role in addressing unmet needs in cancer therapy."

Preclinical • Breast Cancer • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Impact of Post-Therapy Imaging and Dosimetry on Patient Management in Radionuclide Therapy: A Case Study Review (SNMMI 2025) - "Patient 5: Severe fatigue and constipation after Pluvicto therapy were linked to a colon dose of up to 9.6 Gy. Case studies demonstrate the critical role of dosimetry in patient safety and therapy optimization: Patient 1: Acute renal failure following the third Lutathera dose. Dosimetry revealed a kidney dose of only 5 Gy per therapy, below critical thresholds. Investigation confirmed non-compliance with hydration/activity guidelines, leading to patient re-education and therapy continuation."

Case study • Clinical • Review • Acute Kidney Injury • Biliary Cancer • Cholangiocarcinoma • Cholestasis • Constipation • Endocrine Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Neuroendocrine Tumor • Novel Coronavirus Disease • Oncology • Renal Disease • Respiratory Diseases • Solid Tumor

Using Clinical Labs and Diagnostic Reports to Evaluate Organ Uptake Stability and Streamline Dosimetry Workflows in Radionuclide Therapy (SNMMI 2025) - "Purpose/Background: Dosimetry in radionuclide therapies, such as 177Lu-DOTATATE (Lutathera) and 177Lu-PSMA-617 (Pluvicto), is traditionally conducted using at least two imaging time points: at least one early and at least one late post-therapy. The findings support the hypothesis that clinical labs and diagnostic imaging can serve as reliable indicators of organ uptake stability. Although clearance is not specifically tested, these findings have implications in dosimetry workflows that may help streamline dosimetry and increase access to routine dosimetry calculations clinically. If uptake is consistent in the presence of consistent labs and diagnostic performance, then perhaps single time point imaging after initial effective half-life determination may provide accurate dose assessments, reducing the need for multiple imaging sessions in subsequent therapy cycles."

Clinical

An Institutional Framework Using Standardized Checklists for Theranostics Procedures (SNMMI 2025) - "Two theranostics procedures commonly performed at our institution include LutatheraTM (177Lu-Dotatate), which is approved for treating neuroendocrine tumors, and PluvictoTM (177Lu-Vipivotide tetraxetan), which targets prostate-specific membrane antigen (PSMA)-expressing metastatic prostate cancer. With the rapid advancements and growth in the field of theranostics and establishment of new theranostics centers, maintaining high standards for patient safety, organization, and procedural consistency is essential. By sharing the framework that has proven effective at our high-volume institution, we aim to provide a model and launching point for other centers looking to initiate or improve their theranostics programs and workflows. This structured approach can serve as a foundation for enhancing procedural safety and efficiency across the field with the ultimate goal of ensuring the best outcomes for patients undergoing these advanced therapies."

Clinical • Endocrine Cancer • Genito-urinary Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • SSTR

The Case for Population-Based Effective Half-Lives: Addressing Dosimetry Access and Variability in Radionuclide Therapy (SNMMI 2025) - "Purpose/Background: Radionuclide therapies, such as 177Lu-DOTATATE (Lutathera) and 177Lu-PSMA-617 (Pluvicto), rely heavily on accurate dosimetry for optimizing treatment efficacy and minimizing toxicity. This study reveals significant differences between population-based effective half-lives at a single institution and dosimetry estimates found in FDA prescribing information, highlighting the limitations of standardized dosing guidance for diverse clinical populations. While FDA data provides a useful baseline, population-based models derived from local patient data provide an effective way to decrease uncertainty and lower barriers to performing patient dosimetry. Future work should focus on refining population-based approaches to address organ-specific variability and validate their use across diverse clinical settings."

Clinical

RaPTR: Registry for Real-World Radiopharmaceutical Therapy Data (SNMMI 2025) - "Since then, the approval of Lutathera (177Lu-Dotatate) in 2018 and Pluvicto (177Lu-PSMA-617) in 2022 for neuroendocrine tumors and prostate cancer, respectively, has led to exponential growth in the use and importance of RPTs. As the use of RPTs increases with label expansions (e.g., Pluvicto), off-label indications, and new agents, multi-institutional data will be critical for refining treatment paradigms and improving patient outcomes. This robust registry will provide additional, real-world safety data and serve as an indispensable resource for physicians, technologists, and trainees."

Clinical • Real-world • Real-world evidence • Endocrine Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • Thyroid Gland Carcinoma

Peripheral SPECT/CT Imaging Combined with Centralized Dosimetry Expands Access to Patient-Specific Voxel-Based Post-Radiopharmaceutical Therapy Dosimetry (SNMMI 2025) - "For Lu-177 DOTATATE therapy, dosimetry was done for all patients. Patients who received RPT at our institution between 12/2023-12/2024 (Lu-177 PSMA-617) and 4/2023-12/2023 (Lu-177 DOTATE) were included in this analysis. For Lu-177 PSMA-617 patients (n=27), 66% of these patients would have experienced a reduction in drive time. In addition, the percentage of patients living within a 1-hour, one-way drive increased from 37 to 70.4% and within a 2-hour drive from 40.7 to 92.6% by having a peripheral site available for post-treatment dosimetry."

Clinical • Oncology

A Web Application to Streamline Radionuclide Therapy Adverse Event Grading and Dose Modification Guidance (SNMMI 2025) - "The application successfully identified and graded adverse events in simulated and real-world datasets for patients undergoing Lutathera and Pluvicto therapy. Key findings include: Accurate detection of clinically relevant lab-based toxicities based on CTAE Accurate determination of suggested FDA prescribing information dose modifications Users reported a significant reduction in the time required for AE analysis and decision-making compared to traditional workflows. The web app is publicly available currently at the pre-website integration location below: https://therapy-labs.streamlit.app/ Conclusion : This novel web-based application enhances radionuclide therapy workflows by integrating standardized AE grading and dose modification recommendations into a single platform."

Adverse events • Fatigue • Hematological Disorders • Hepatology • Neutropenia • Oncology • Thrombocytopenia • Xerostomia