Solucin (177Lu-edotreotide) / ITM Isotopen Technologien Munchen, China Grand Pharma - LARVOL DELTA

Efficacy and safety of [177Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial (ENETS 2025) - "CONCLUSION The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful PFS benefit with [177Lu]Lu-edotreotide vs. everolimus. [177Lu]Luedotreotide was well tolerated, supporting its potential as a treatment option for GEP-NET."

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

A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217). (PubMed, BMC Cancer) - P3 | "The LEVEL trial will investigate if 177Lu-edotreotide has the potential to be incorporated as a standard treatment option for patients with NETs from the lung and Thymus."

Clinical • Clinical protocol • HEOR • Journal • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR • SSTR2

Efficacy, safety and subgroup analysis of 177Lu-edotreotide vs everolimus in patients with grade 1 or grade 2 GEP-NETs: Phase III COMPETE trial (ESMO 2025) - P3 | "Table: 1706O Subgroup 177 Lu-edotreotide EVE p value Stratified HR (95%CI) n mPFS (months) n mPFS (months) Primary tumor origin GE-NET P-NET 88 119 23.9 24.5 43 59 12.0 14.7 0.1072 0.1033 0.7 (0.4-1.1) 0.7 (0.4-1.1) Tumour grade (local) Grade 1 Grade 2 43 164 30.0 21.8 29 73 23.7 9.2 0.8745 0.0031 0.9 (0.4-2.0) 0.6 (0.4-0.8) Prior medical therapy Treatment naïve (1 st line) Prior therapy (2 nd line) 30 177 Not reached 23.9 17 85 18.1 14.1 0.2666 0.0444 0.6 (0.2-1.5) 0.7 (0.5-1.0) Conclusions 177 Lu-edotreotide compared to EVE significantly improved PFS and ORR in patients with GEP-NETs. 177 Lu-edotreotide demonstrated meaningful clinical benefit across the subgroups (origin, grade and prior treatment) and was well-tolerated."

Clinical • P3 data • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • SSTR

COMPOSE: Pivotal phase III trial to compare 177Lu-edotreotide with best standard of care for well-differentiated aggressive grade 2 and grade 3 gastroenteropancreatic neuroendocrine tumours (ESMO 2022) - P3 | "For well-differentiated high grade 2 and 3 GEP-NETs, current therapies include peptide receptor radionuclide therapy (PRRT), somatostatin analogues, chemotherapy, cytoreduction and molecular targeted therapies (everolimus, sunitinib) with no specified use sequence...More sites and countries will follow. Results are expected to increase treatment options for patients with well-differentiated aggressive grade 2 and 3 GEP-NETs, including for 1st-line therapy."

P3 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

PRRT With 177Lu-Edotreotide Improves Outcomes vs Everolimus in Metastatic GEP-NETs: With Jonathan R. Strosberg, MD (OncLive) - "In our exclusive interview, Dr Strosberg contextualized 177Lu-edotreotide as a PRRT approach that is mechanistically similar to lutetium Lu 177 dotatate (Lutathera) but uses a different somatostatin analog vector. He also emphasized the relevance of COMPETE as a head-to-head comparison of lutetium-based PRRT vs an active standard option everolimus (Afinitor) in this setting. He summarized key efficacy signals, including an improvement in progression-free survival and higher response rates with PRRT vs everolimus, and discussed subgroup trends by grade, primary site, and line of therapy. He also highlighted practical takeaways relevant to real-word clinical practice."

Audio

Dr Strosberg on Survival Outcomes With 177Lu-edotreotide in Select SSTR+ GEP-NET Subgroups (OncLive) - "Strosberg concluded that the statistical significance observed in the second-line group was primarily due to the way the study was powered, as approximately 85% of the total participants were treated in the second line. He emphasized that despite the lack of statistical significance in other subgroups, including those in the first-line setting, the strong trends toward improvement across tumor grades and locations suggest a broad benefit for this therapy in the GEP-NET population."

Video

KinLET: Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: ITM Solucin GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Brain Cancer • CNS Tumor • Embryonal Tumor • Hematological Malignancies • Lymphoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Systematic review and meta-analysis of the efficacy and safety of [177Lu]Lu-edotreotide ([177Lu]Lu-DOTATOC) for the treatment of neuroendocrine tumors. (PubMed, J Neuroendocrinol) - "Overall, these findings suggest that the efficacy and safety of [177Lu]Lu-edotreotide are in line with those reported for other RPTs in similar clinical settings. Clinical Trial Registration: PROSPERO 2024 CRD42024518028."

Journal • Retrospective data • Review • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (GlobeNewswire) - "The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026...The NDA submission for 177Lu-edotreotide is supported by results from the Phase 3 COMPETE study, a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs as a first- or second-line treatment."

FDA filing • PDUFA • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Efficacy of 177Lu-edotreotide vs Everolimus in patients with Grade 1 or Grade 2 GEP-NETs: Phase 3 COMPETE trial (post hoc subgroup analyses) (NANETS 2025) - "The efficacy of 177Lu-edotreotide was largely maintained across the subgroups (origin, grade, and prior treatment). These findings confirm the meaningful clinical benefit of 177Lu-edotreotide vs. everolimus in GEP-NETs patients with high unmet needs."

Clinical • P3 data • Retrospective data • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • SSTR

First-line Treatment with [177Lu]Lu-edotreotide ([177Lu]Lu-DOTATOC) in patients with NETs: a SwissNET Registry Analysis (NANETS 2025) - "CONCLUSIONS This is the first report of first-line treatment with 177Lu-edotreotide in a real-world population. First-line therapy with 177Lu-edotreotide can be considered a promising treatment option for patients with metastatic, somatostatin receptor positive, well-differentiated NETs of different origins."

Clinical • Neuroendocrine Tumor • Oncology • SSTR

Efficacy and safety of [177Lu]Lu-edotreotide ([177Lu]Lu-DOTATOC) for the treatment of neuroendocrine tumors (NETs) – a systematic literature review (SLR) and meta-analysis (NANETS 2025) - "Response and PFS outcomes were encouraging in relation to recent phase 3 [177Lu]Lu-edotreotide data from COMPETE. The safety/tolerability profile of [177Lu]Luedotreotide also appears to be good and in line with the findings in COMPETE."

Retrospective data • Review • Neuroendocrine Tumor • Oncology • Solid Tumor

ITM Announces Phase 3 COMPETE Data Demonstrating a Statistically Significant Higher Objective Response Rate with n.c.a. 177Lu-edotreotide (ITM-11) vs. Everolimus in Patients with Gastroenteropancreatic Neuroendocrine Tumors at ESMO 2025 (GlobeNewswire) - "mPFS, by central assessment, was longer in the 177Lu-edotreotide arm in patient subgroups: gastroenteric NET, pancreatic NET, Grade 1, Grade 2, 1st line, 2nd line; Frequency of patients who experienced treatment-emergent adverse events (TEAEs) leading to premature study discontinuation was lower in the 177Lu-edotreotide arm"

P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Cancer

ITM to Announce Phase 3 COMPETE Trial Post Hoc Subgroup Analyses and Host Satellite Symposium at NANETS 2025 (The Manila Times) - "The company will also host a medical booth (booth number: 16) at the conference and a satellite symposium on advancing targeted therapies and molecular imaging in gastroenteropancreatic neuroendocrine tumors (GEP-NETs)."

P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Cancer

Feasibility of single-time-point dosimetry application in 177 Lu -DOTATATE/DOTATOC-treated pediatric neuroblastoma (EANM 2025) - "The corresponding correlation values were 0.97 (lesions), 0.77 (kidneys), 0.35 (bone marrow), 0.48 (liver), and 0.93 (spleen) Conclusion The 96-hour STP H method represents a clinically feasible alternative to MTP for dosimetric evaluation in pediatric NB patients undergoing 177 Lu-DOTATATE therapy. It also shows satisfactory performance, particularly for renal dosimetry, in the context of 177 Lu-DOTATOC treatment."

Clinical • Neuroblastoma • Pediatrics • Solid Tumor

Alpha Peptide Receptor Radionuclide Therapy (PRRT) with the somatostatin receptor (SSTR)-antagonist 225Ac-DOTA-LM3 as rescue therapy after failure of conventional treatments in neuroendocrine neoplasm G3 (EANM 2025) - "Hydration, antiemetics, dexamethasone and para-aminohippuric acid were provided...Prior treatments: SSTR analogues (100%), chemotherapy (93%), surgery (64%), 177Lu-DOTATATE (64%), Everolimus (64%), 177Lu-DOTA-LM3 (36%), 177Lu-DOTATOC (29%), 90Y-DOTATOC (21%), hepatic intra-arterial PRRT (14%), 90Y-DOTATATE (7%)...Conclusion This retrospective analysis showed that α-PRRT with SSTR-antagonist 225 Ac-DOTA-LM3 in heavily pre-treated advanced well-differentiated NEN G3 patients failing standard treatments is well-tolerated , with favourable safety and encouraging efficacy results. Prospective randomized trials are warranted to confirm and optimize its clinical use."

Anemia • Endocrine Cancer • Hematological Disorders • Hepatocellular Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • SSTR

Translating evidence into practise: The role of 177LU-Edotreotide in nets (EANM 2025) - "Sponsored by ITM Isotope Technologies Munich SE"

From concept to clinic: The Origins of 177LU-Edotreotide in nets (EANM 2025) - "Sponsored by ITM Isotope Technologies Munich SE"

SSTR-Targeting Theranostics in NETs and Beyond: Milestones and New Frontiers (EANM 2025) - "Sponsored by ITM Isotope Technologies Munich SE Learn more about the development and emerging clinical role of 177Lu-edotreotide in the treatment of neuroendocrine tumors, focusing on its scientific origins and current evidence supporting its use in gastroenteropancreatic NETs. Additionally, the session will explore future directions in SSTR-targeted therapies."

Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

ITM Presents Dosimetry Data from Phase 3 COMPETE Trial Supporting Favorable Efficacy and Safety Profile with n.c.a. 177Lu-edotreotide (ITM-11) in Patients with Gastroenteropancreatic Neuroendocrine Tumors at EANM 2025 Annual Congress (GlobeNewswire) - "Absorbed dose in tumors was significantly higher compared to normal organs, supporting therapeutic efficacy and safety; Normal organ absorbed doses were well below safety thresholds; Grade ≥1 renal adverse events occurred less often with 177Lu-edotreotide vs. everolimus (14.7% vs. 21.2%)....Additional dosimetry data will be presented at future medical congresses."

P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Cancer

ITM to Present COMPETE Dosimetry Data and Host Satellite Symposium at EANM 2025 (GlobeNewswire)

P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Cancer

START-NET: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Lund University Hospital | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

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

ITM to Present New Subgroup Analysis Data from the COMPETE Trial at ESMO 2025 and Host an Educational Event for Healthcare Professionals (The Manila Times)

P3 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor

Predicting the [177Lu]Lu-edotreotide Uptake in Tumors using Pre-therapeutic Ga-68 PET/CT Imaging (SNMMI 2025) - "Purpose/Background: The COMPETE trial is a prospective, randomized, controlled, open-label, multicenter phase 3 study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with [177Lu]Lu-edotreotide (compared to targeted molecular therapy with everolimus) in patients with inoperable, progressive, somatostatin receptor positive (SSTR-positive), neuroendocrine tumors of gastroenteric (GE-NET) or pancreatic (P-NET) origin. 130 participants (76 male/54 female) were included for this analysis. Both SUVmean PET/CT (p < 0.001) and tumor type (p = 0.016) were significantly associated with SUVmean SPECT/CT. The relationship between SUVmean by SPECT/CT and SUVmean by PET/CT is shown in Figure 1."

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

Alpha Peptide Receptor Radionuclide Therapy (PRRT) with the SSTR antagonist 225Ac-DOTA-LM3 as rescue therapy after failure of PRRT with SSTR agonists/conventional treatment options in neuroendocrine neoplasm G3 (remote) (SNMMI 2025) - "Hydration, premedication (antiemetics/dexamethasone) and para-aminohippuric acid for renal protection were provided during each cycle...Previous PRRT included: 177Lu-DOTATATE (n=7, 58%), 177Lu-DOTATOC (n=5, 42%), 90Y-DOTATOC (n=3, 25%), 90Y-DOTATATE (n=1, 8%), intra-arterial liver administration of 177Lu-DOTATATE or 90Y-DOTATOC (n=1 each, 8%)... Our retrospective analysis shows that α-PRRT with the SSTR antagonist 225Ac-DOTA-LM3 is well-tolerated with a favorable long-term safety profile. In patients with advanced NEN G3 failing standard treatments, including PRRT with SSTR agonists, and no other therapeutic options, promising survival outcomes and very encouraging efficacy results were achieved. Efficacy and survival were comparable with those in a NEN G2 cohort treated under the same conditions."

Acute Myelogenous Leukemia • Anemia • Colorectal Cancer • Endocrine Cancer • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Neuroendocrine Tumor • Oncology • Pain • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • SSTR