Solucin (177Lu-edotreotide) / ITM Isotope Technologies Munich, China Grand Pharma - LARVOL DELTA

177Lu-edotreotide Absorbed Dose In Patients with Gastroenteropancreatic Neuroendocrine Tumors: Dosimetry Results from Compete (ASTRO 2026) - P3 | "Purpose/Objective(s): In the Phase 3 COMPETE trial, patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) were randomized to receive 177Lu-edotreotide 7.5 ± 0.7 GBq every 3 months (maximum 4 cycles) or everolimus 10 mg daily (NCT03049189). Kidney ADCs remained constant over time with low intra-patient variability, which allows for estimating individual radiation burden based on cycle 1 dosimetry data. The tumor ADC decreased over time, but the tumor-to-kidney ADC ratio remained positive across cycles. Future research will explore the relationship between absorbed dose and treatment response."

Clinical • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Renal Cell Carcinoma • Solid Tumor

Re-Treatment with 177Lu-edotreotide in Patients with Progressive NETs: A SwissNET Registry Analysis (ASTRO 2026) - "Re-treatment with 177Lu-edotreotide in this small retrospective cohort demonstrated potential for positive efficacy outcomes in patients with progressive NETs after prior 177Lu-edotreotide therapy. Further studies are needed to strengthen the evidence. Table 1: Treatment Data and Efficacy Results"

Clinical • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

ITM and Lumara Bio Announce Upcoming Dosimetry and Re-treatment Data Presentations on ¹⁷⁷Lu-edotreotide at ASTRO 2026 (The Manila Times) - "One poster will feature Phase 3 COMPETE trial dosimetry results for 177Lu-edotreotide in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A second poster will highlight findings from a registry analysis of re-treatment with 177Lu-edotreotide in patients with progressive neuroendocrine tumors (NETs)."

Clinical data • P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

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

177Lu-edotreotide for the treatment of pancreatic neuroendocrine tumours: A subgroup analysis from the COMPETE study (ENETS 2026) - "177Lu-edotreotide showed improved outcomes and a favourable safety profile compared with everolimus for pa - tients with P-NETs."

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

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

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

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

[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial. (PubMed, Lancet) - P3 | "[177Lu]Lu-edotreotide led to statistically significant and clinically meaningful improvements in progression-free survival. Efficacy and harms results support the use of [177Lu]Lu-edotreotide in early lines of therapy in patients with advanced, progressive GEP NETs."

Head-to-Head • Journal • P3 data • Gastrointestinal Neuroendocrine Tumor • Hematological Disorders • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • SSTR

Telix Pharmaceuticals Limited…announces it has signed a strategic agreement to lead a merger with ITM Isotope Technologies Munich SE ("ITM"), a global leader in radioisotope production and radiopharmaceutical development. (The Manila Times) - "ITM-11 has completed a successful Phase 3 trial (COMPETE, NCT03049189) and fully enrolled a second indication expansion Phase 3 study (COMPOSE, NCT04919226) with an interim analysis expected in H1 2027....Additional contingent consideration of up to US$700 million will become payable upon the achievement of specified regulatory approvals and sales milestones for ITM-11 as set out below: Up to US$250 million upon U.S. Food and Drug Administration (FDA) approval of ITM-11 across three different indications: US$100 million upon FDA approval for expected first indication in G1-G2 GEP-NETs no later than December 31, 2027; US$100 million upon FDA approval for G2-G3 GEP-NETs indication no later than December 31, 2030; and US$50 million upon FDA approval for Lung NETs indication no later than December 31, 2031; and Up to US$450 million based on ITM-11 net global sales in FY 2030 in excess of US$150 million."

M&A • P3 data • Trial completion • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

ITM Isotope Technologies Munich SE… announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (GlobeNewswire) - "The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved. The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties....The Company intends to resubmit to complete the review of the NDA."

CRL • FDA filing • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

ITM Isotope Technologies Munich SE (ITM)…introduced Lumara Bio as a dedicated oncology therapeutics division that combines ITM’s existing pipeline and the internal teams supporting its development and commercialization (GlobeNewswire) - "Lumara Bio will operate as a defined division within ITM to focus key resources toward commercial readiness for its most advanced drug candidate, 177Lu-edotreotide (ITM-11), which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026, alongside its broader early- and late-stage drug development activities."

Commercial • PDUFA • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Second-line 177Lu-edotreotide shows promise in GEP NETs. (PubMed, Nat Rev Clin Oncol) - No abstract available

Journal • Gastrointestinal Neuroendocrine Tumor

ITM Isotope Technologies...announced the publication of its primary result analysis of the Phase 3 COMPETE trial in The Lancet. (The Manila Times) - "The clinical data demonstrated that non-carrier-added (n.c.a.) 177Lu-edotreotide (also known as 177Lu-edotreotide or ITM-11) significantly improved progression-free survival (PFS) compared to everolimus in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)...Median PFS was significantly longer in the 177Lu-edotreotide arm compared to everolimus (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48-0.95]); Objective response rate (ORR) was significantly higher in the 177Lu-edotreotide arm compared to everolimus in central review"

P3 data • Gastrointestinal Neuroendocrine Tumor • Pancreatic Cancer • Pancreatic Neuroendocrine Tumor

ITM Announces Phase 3 COMPETE Data Supporting Single-Timepoint Dosimetry for n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) at SNMMI 2026 (The Manila Times) - "The PBMS NLMEM approach accurately estimated absorbed doses for both kidneys and tumors using a single imaging timepoint, achieving mean absolute percentage error (MAPE) values of 3-20% for kidney dosimetry across evaluated timepoints; PBMS NLMEM outperformed comparator single-timepoint dosimetry methods with respect to MAPE and R20 for kidney absorbed dose estimation across all evaluated timepoints; Findings suggest individualized dosimetry may be achievable with just one scan approximately six hours after treatment, offering an alternative for centers with limited imaging capacity and potentially expanding the routine use of personalized dosimetry."

P3 data • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Quality of life in patients with gastroenteropancreatic neuroendocrine tumors receiving 177Lu-edotreotide or everolimus: Results from the COMPETE study. (ASCO 2026) - P3 | "Consistent with the overall COMPETE outcomes, this analysis demonstrated clinically meaningful and durable HRQoL benefits for 177Lu-edotreotide compared with everolimus. Time to deterioration in global health status/QoL (≥10 points). aEstimated via Kaplan-Meier method."

Clinical • HEOR • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

ITM Announces Phase 3 COMPETE Patient-Reported Quality of Life Data with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) vs. Everolimus at ASCO 2026 (PRNewswire) - "On average, patients on the ¹⁷⁷Lu-edotreotide arm maintained their quality of life (score change: +0.9) while patients in the everolimus arm experienced a meaningful decline in quality of life (score change: -9.9). Patients on ¹⁷⁷Lu-edotreotide experienced a longer period of time before their quality of life began to decline: a median of 10.3 months vs. 2.3 months for everolimus. A meaningful overall improvement in quality of life was reported by 43.5% of patients on ¹⁷⁷Lu-edotreotide vs. 30.4% of those on everolimus. Among those who improved, median duration of improvement was 22.0 months vs. 10.2 months, respectively."

P3 data • Patient reported outcomes • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Accurate single-time-point dosimetry of [177Lu]Lu-edotreotide using non-linear mixed-effects modeling: results from the COMPETE Phase 3 trial (SNMMI 2026) - P3 | "Dosimetry using a single timepoint within PBMS NLMEM has the potential to provide accurate absorbed dose estimates for kidneys and tumors in [¹⁷⁷Lu]Lu-edotreotide therapy. The method outperforms commonly used STP approaches with respect to MAPE and R20 and supports wider clinical adoption of individualized dosimetry with fewer imaging requirements, potentially even with a single timepoint 6h after administration. Thus, STP dosimetry offers an alternative for centers with limited imaging capacity and may help to reduce inter-center disparities while supporting more personalized radiopharmaceutical treatments."

P3 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Renal Cell Carcinoma • Solid Tumor

LEVEL: Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: Grupo Espanol de Tumores Neuroendocrinos | N=120 ➔ 170 | Trial completion date: Jul 2028 ➔ Oct 2029 | Trial primary completion date: Mar 2028 ➔ Mar 2029

Enrollment change • Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thymus Cancer • SSTR

ITM to Announce Dosimetry Data from the Phase 3 COMPETE Trial at SNMMI 2026 and Host Satellite Symposium (The Manila Times) - "During the conference, ITM will exhibit its innovative isotope portfolio, including Lutetium-177, Actinium-225 and Terbium-161...The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus."

P3 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

ITM to Announce Quality of Life Data from the Phase 3 COMPETE Trial in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) at ASCO 2026 (GlobeNewswire)

P3 data • Gastrointestinal Neuroendocrine Tumor

ITM11 Expanded Access Program (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: ITM Solucin GmbH

New trial • Brain Cancer • Meningioma • Oncology • Solid Tumor

ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026 Conference (The Manila Times) - "Median PFS was longer in the 177Lu-edotreotide arm compared to everolimus (24.5 months vs. 14.7 months; p=0.114; HR 0.70, 95% CI [0.45, 1.09]) and ORR in the 177Lu-edotreotide arm was 33.3% vs. 3.6% in everolimus arm; ORR in the 177Lu-edotreotide arm was ≥ 30% in P-NET patients with non-functional disease, across all patients regardless of line of therapy and Ki-67 index. This includes 38.1% ORR in P-NET patients with non-functional disease and 34.2% ORR in patients with a Ki-67 index ≥10%; Median overall survival was numerically longer in the 177Lu-edotreotide arm compared to everolimus (65.7 months vs. 49.3 months) at the time of analyses; data continue to mature with ongoing five-year follow up."

P3 data • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026 (The Manila Times) - "The company will also host a conference booth (#6) and an interactive symposium on March 5, 2026, bringing together leading experts in radiopharmaceutical oncology to share their perspectives on key challenges and emerging clinical approaches for the treatment of neuroendocrine tumors (NETs)."

P3 data • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

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."

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