This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

Start Date01 Jan 2025

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+3]

NCT06607692

/ RecruitingPhase 2IIT

Single-arm Open-label Phase II Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed)

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

Start Date01 Oct 2024

Sponsor / Collaborator-

NCT05687123

/ RecruitingPhase 1IIT

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

Start Date14 Aug 2024

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Lutetium Dotatate LU-177

100 Translational Medicine associated with Lutetium Dotatate LU-177

100 Patents (Medical) associated with Lutetium Dotatate LU-177

1,106

Literatures (Medical) associated with Lutetium Dotatate LU-177

01 Feb 2025·ANNALS OF NUCLEAR MEDICINE

A Monte Carlo study comparing dead-time losses of a gamma camera between tungsten functional paper and lead sheet for dosimetry in targeted radionuclide therapy with Lu-177

Article

Author: Iwanaga, Haruna ; Kato, Katsuhiko ; Nishii, Ryuichi ; Abe, Shinji ; Asano, Yuki ; Nakanishi, Kohei ; Fujita, Naotoshi

Abstract:

Objective:

Dead-time loss is reported to be non-negligible for some patients with a high tumor burden in Lu-177 radionuclide therapy, even if the administered activity is 7.4 GBq. Hence, we proposed a simple method to shorten the apparent dead time and reduce dead-time loss using a thin lead sheet in previous work. The collimator surface of the gamma camera was covered with a lead sheet in our proposed method. While allowing the detection of 208-keV gamma photons of Lu-177 that penetrate the sheet, photons with energies lower than 208 keV, which cause dead-time loss, were shielded. In this study, we evaluated the usefulness of tungsten functional paper (TFP) for the proposed method using Monte Carlo simulation.

Methods:

The count rates in imaging of Lu-177 administered to patients were simulated with the International Commission on Radiological Protection (ICRP) 110 phantom using the GATE Monte Carlo simulation toolkit. The simulated gamma cameras with a 0.5-mm lead sheet, 1.2-mm TFP, or no filter were positioned closely on the anterior and posterior sides of the phantom. The apparent dead times and dead-time losses at 24 h after administration were calculated for an energy window of 208 keV ± 10%. Moreover, the dead-time losses at 24–120 h were analytically assessed using activity excretion data of Lu-177-DOTATATE.

Results:

The dead-time loss without a filter was 5% even 120 h after administration in patients with a high tumor burden and slow excretion, while those with a lead sheet and TFP were 0.22 and 0.58 times less than those with no filter, respectively. The count rates with the TFP were 1.3 times higher than those with the lead sheet, and the TFP could maintain primary count rates at 91–94% of those without a filter.

Conclusions:

Although the apparent dead time and dead-time loss with the lead sheet were shorter and less than those with TFP, those with TFP were superior to those without a filter. The advantage of TFP over the lead sheet is that the decrease in primary count rates was less.

01 Jan 2025·Journal of Applied Clinical Medical Physics

Enhancing safety: Multi‐institutional FMEA and FTA on 177Lu$^{177}{\rm Lu}$‐based radio‐pharmaceutical therapy

Article

Author: George, Siju C. ; Lee, Yongsook C. ; Tolakanahalli, Ranjini ; Gallo, Sven L. ; Zoberi, Jacqueline E. ; Samuel, E. James Jebaseelan ; Aguirre, Santiago ; Maughan, Nichole M.

Abstract:

Purpose:

This study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of DOTATATE (LUTATHERA) and PSMA‐617 (PLUVICTO). The quality management (QM) process in radiopharmaceutical therapies (RPTs) requires collaboration between nuclear medicine (NM) and radiation oncology (RO) departments. As part of a multi‐institutional study, we surveyed various departments to identify and analyze failure modes, leading to a proposed comprehensive QM program. RPT teams in RO or NM clinics can benefit from this study by continually improving their practice.

Methods:

We reviewed the literature to investigate the administration of Pluvicto and Lutathera, focusing on prospective procedural failures and potential failure modes (PFMs) and their outcomes. We distributed an FMEA survey to multiple experienced centers in ‐based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential failures.

Results:

The findings from the literature review and survey responses on the prospective study have identified several critical areas at risk of failure. These areas include non‐optimized treatment delivery, inadequate patient monitoring, and lack of safety training, leading to radiation contamination from the dose excreted by the patients after treatment administration. A segmented FTA was created based on the FMEA results, focusing on radiation contamination with a high RPN value.

Conclusion:

By identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of ‐based RPTs. Given the limited number of prospective risk analysis studies in RPTs, our research addresses the necessity for more such studies and recommends methods to apply this study to other RPTs.

01 Jan 2025·SURGERY

Surgery enhances the effectiveness of peptide receptor radionuclide therapy in metastatic gastroenteropancreatic neuroendocrine tumors

Article

Author: Gujarathi, Rushabh ; Vaghaiwalla, Tanaz ; Keutgen, Xavier M. ; Liao, Chih-Yi ; Tobias, Joseph ; Abou Azar, Sara ; Keutgen, Xavier M ; Nordgren, Rachel ; Feinberg, Nicholas ; Millis, J. Michael ; Millis, J Michael

BACKGROUND:

With the advent of peptide receptor radionuclide therapy, the timing and sequence of surgery in the treatment of metastatic gastroenteropancreatic neuroendocrine tumors merits further study. We hypothesized that surgery before peptide receptor radionuclide therapy might enhance its effectiveness in patients with metastatic gastroenteropancreatic neuroendocrine tumors.

METHODS:

Eighty-nine patients with metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors treated with ¹⁷⁷Lutetium-dotatate peptide receptor radionuclide therapy between 2018 and 2023 were included. Fifty-six patients underwent surgery (primary tumor resection and/or liver debulking) before peptide receptor radionuclide therapy and 33 patients did not. Primary outcome was progression-free survival according to Response Evaluation Criteria in Solid Tumors. Pretreatment dotatate positron emission tomography/computed tomography was used to calculate tumor volumes.

RESULTS:

The surgery and no-surgery groups were well-matched. Median progression-free survival after peptide receptor radionuclide therapy was 15.6 months (interquartile range, 9.1-22.7 months) in the no-surgery group compared with 26.1 months (interquartile range, 12.7-38.1 months) in the surgery group (P = .04). On subgroup analysis, median progression-free survival was 18.1 months (interquartile range, 11.9-38.4 months) in patients who underwent primary tumor resection only compared with 26.2 months (interquartile range, 14.0-38.1 months) in patients who underwent liver debulking (P = .04). Tumor volume was lowest in patients who underwent liver debulking (median 146.07 mL³) compared with no surgery (median 626.42 mL³) (P = .001). On univariable analysis, a tumor volume <138.8 mL³ was associated with longer progression-free survival (hazard ratio, 2.03; 95% confidence interval, 0.95-4.34, P = .05), with a median progression-free survival of 38.1 months (interquartile range, 16.9-41.3 months) compared with 17.8 months (interquartile range, 10.8-28.7 months).

CONCLUSION:

Surgery may enhance the effectiveness of ¹⁷⁷Lutetium-dotatate in the treatment of metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors. This positive effect may be the result of a lower tumor volume in patients after surgery. Our findings fortify the concept of using surgical debulking to improve systemic therapies such as peptide receptor radionuclide therapy.

216

News (Medical) associated with Lutetium Dotatate LU-177

04 Feb 2025

·www.prnewswire.com

Global Peptide-Drug Conjugate Market to Show Enormous Growth at a CAGR of ~29% by 2032 | DelveInsight

The increasing global prevalence of cancer is fueling the demand for peptide-drug conjugates as targeted therapies, providing improved effectiveness and lower systemic toxicity than conventional treatments. Additionally, the expanding use of peptide-based therapeutics, driven by their enhanced treatment outcomes, biocompatibility, and precise tumor-targeting capabilities, is further propelling market growth. LAS VEGAS , Feb. 4, 2025 /PRNewswire/ -- DelveInsight's Peptide-drug Conjugate Market Insights report provides the current and forecast market analysis, individual leading peptide-drug conjugate companies' market shares, challenges, peptide-drug conjugate market drivers, barriers, trends, and key market peptide-drug conjugate companies in the market. Key Takeaways from the Peptide-drug Conjugate Market Report As per DelveInsight estimates, North America is anticipated to dominate the global peptide-drug conjugate market during the forecast period. The LUTATHERA (lutetium Lu 177 dotatate) category in the peptide drug conjugates market dominated with a market share of 37% in 2024. Notable peptide-drug conjugate companies such as Novartis AG, Oncopeptides AB, Cybrexa Therapeutics, Avacta Therapeutics, ProteinQure, Theratechnologies Inc., CBP, Soricimed Biopharma, NMS Group S.p.A., Mainline Scientific LLC., Bicycle Therapeutics, and several others, are currently operating in the peptide-drug conjugate market. In April 2024, PeptiDream Inc. announced the expansion of its peptide discovery collaboration with Novartis Pharma AG. Using its proprietary Peptide Discovery Platform System (PDPS®), PeptiDream identified and optimized macrocyclic peptides for conjugation with radionuclides for therapeutic and diagnostic applications. In March 2023, Ono Pharmaceutical Co., Ltd. announced that it entered into a drug discovery collaboration agreement with PeptiDream Inc., to discover and develop novel macrocyclic constrained peptide drugs against multiple targets of Ono's interest. To read more about the latest highlights related to the PDC market, get a snapshot of the key highlights entailed in the Global Peptide-drug Conjugate Market Report Peptide-drug Conjugate Overview Peptide-drug conjugates (PDCs) are an emerging class of targeted therapeutics that combine the specificity of peptides with the potent efficacy of cytotoxic drugs. These conjugates leverage peptides as targeting ligands to deliver drugs selectively to diseased cells, such as cancerous or infected tissues, thereby minimizing off-target toxicity. The design of PDCs involves three key components: a targeting peptide, a linker, and a payload (therapeutic drug). The peptide is typically selected based on its ability to recognize and bind to overexpressed receptors on diseased cells, ensuring precise drug delivery. The linker plays a crucial role in controlling drug release, which can be triggered by specific conditions like enzymatic cleavage or pH changes in the tumor microenvironment. Compared to antibody-drug conjugates (ADCs), PDCs offer advantages such as smaller size, better tissue penetration, and lower immunogenicity. They are particularly promising for targeting intracellular pathways, where antibodies may struggle to enter. Advances in peptide engineering, including modifications to enhance stability and binding affinity, have further improved the efficacy of PDCs in preclinical and clinical settings. PDCs are being explored in various therapeutic areas, including oncology, infectious diseases, and metabolic disorders. As research progresses, optimizing peptide selection, linker chemistry, and payload potency will be critical in developing next-generation PDCs with superior safety and efficacy profiles. Peptide-drug Conjugate Market Insights North America dominated the global peptide drug conjugates market in 2024, accounting for the largest share of 56.70%. The market is expected to grow at a CAGR of 28.47% from 2025 to 2032, primarily driven by the increasing incidence of cancer in the U.S. Additionally, the region's market growth is fueled by rising collaborations among key industry players for PDC development and increasing investments in this sector. Furthermore, major companies in North America are emphasizing research and development to create innovative peptide-drug conjugates. For instance, in February 2021, Theratechnologies Inc. announced that the U.S. FDA granted fast-track designation to TH1902, a docetaxel-based peptide-drug conjugate, for treating patients with sortilin-positive recurrent advanced solid tumors that are resistant to standard therapies. In addition, in April 2024, Novartis, which already has two FDA-approved PDC drugs, expanded its collaboration with PeptiDream to further develop peptide-drug conjugates in a deal exceeding USD 2.8 billion. These factors collectively contribute to the anticipated growth of the peptide drug conjugates market in the region. To know more about why North America is leading the market growth in the PDC market, get a snapshot of the Peptide-drug Conjugate Market Outlook Peptide-drug Conjugate Market Dynamics The peptide-drug conjugate market is witnessing significant growth, driven by advancements in targeted therapies and the increasing prevalence of cancer and other chronic diseases. PDCs combine the specificity of peptides with the potency of cytotoxic drugs, offering an improved therapeutic index compared to traditional chemotherapy. With growing interest in precision medicine, pharmaceutical companies are heavily investing in PDC research and development, leading to an expanding pipeline of clinical candidates. One of the key market drivers is the rising demand for novel drug delivery systems that enhance efficacy while minimizing off-target effects. Peptides, due to their high specificity and low immunogenicity, serve as excellent carriers for cytotoxic payloads. Additionally, advancements in peptide synthesis and linker technologies have improved the stability and half-life of PDCs, making them more viable for clinical applications. Companies such as Bicycle Therapeutics and PeptiDream are leading the innovation in this space. Despite the promising outlook, the PDC market faces challenges such as manufacturing complexities, high development costs, and regulatory hurdles. Peptide synthesis and conjugation processes require stringent quality control, and scalability remains a concern. Furthermore, competition from other targeted therapies, such as ADCs and small-molecule inhibitors, poses a challenge for widespread adoption. Looking ahead, growth opportunities exist in expanding indications beyond oncology, such as antimicrobial, autoimmune, and neurodegenerative diseases. Strategic collaborations between biotech firms and large pharmaceutical companies are accelerating clinical development, while advancements in artificial intelligence and computational modeling are further refining peptide design and optimization. With ongoing innovations and increasing investments, the PDC market is poised for substantial expansion in the coming years. Get a sneak peek at the PDC market dynamics @ Peptide-drug Conjugate Market Dynamics Analysis Peptide-drug Conjugate Market Assessment Peptide-drug Conjugate Market Segmentation Peptide-drug Conjugate Market Segmentation By Product: LUTATHERA (lutetium Lu 177 dotatate), PEPAXTI (Melphalan flufenamide), and PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) Peptide-drug Conjugate Market Segmentation By Cancer Type: Prostate Cancer, Gastrointestinal Cancer, Multiple Myeloma Peptide-drug Conjugate Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the PDC market are set to emerge as the trendsetter explore @ Peptide-drug Conjugate Companies Table of Contents Interested in knowing the PDC market by 2032? Click to get a snapshot of the Peptide-drug Conjugate Market Trends Related Reports Antibody-drug Conjugates in Oncology Competitive Landscape Antibody-drug Conjugates in Oncology Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC in oncology companies, including Jiangsu Hengrui Medicine Co., Bio-Thera Solutions, MediLink Therapeutics, Byondis, AbbVie, Oxford BioTherapeutics, Iksuda Therapeutics, Novelty Nobility, LegoChem Biosciences, DualityBio, Lepu Biopharma, Ambrx, CSPC ZhongQi Pharmaceutical Technology, MacroGenics, ADC Therapeutics, Genor Biopharma, CStone Pharmaceuticals, AstraZeneca, Alteogen, Biocity Biopharmaceutics, among others. Antibody-drug Conjugates Competitive Landscape Antibody-drug Conjugates Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Antibody-drug Conjugates Market Antibody Drug Conjugates Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ADC companies, including Sorrento Therapeutics, Ambrx, MacroGenics, SOTIO Biotech, Klus Pharma, BioAtla, BiOneCure Therapeutics, Shanghai Miracogen, ProfoundBio, ImmunoGen, Arcus Biosciences, CytomX Therapeutics, RemeGen, Bliss Biopharmaceutical, Aivita Biomedical, CoImmune, Zenith Epigenetics, Sutro Biopharma, Ambrx, Mythic Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Byondis, MediLink Therapeutics (Suzhou), Oncomatryx Biopharma, MacroGenics, Shanghai Miracogen, Mirati Therapeutics, Ambrx, Orum Therapeutics, Silverback Therapeutics, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Aivita Biomedical, Northwest Biotherapeutics, Daiichi Sankyo, Merck, Pfizer, GSK, AstraZeneca, Eisai, FOSUN PHARMA, LaNova, Mabwell Therapeutics, MBRACE THERAPEUTICS, MINGHUSI PHARMACEUTICALS, BioNTech , Bio-Thera, Corbus Pharmaceuticals, AbbVie, Multitude Therapeutics, Innovent, OnCusp Therapeutics, Simcere, Ymmunobio, Jiangsu Hengrui Medicine, among others. Bispecific Antibody Competitive Landscape Bispecific Antibody Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key bispecific antibodies companies, including Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackPDC

28 Jan 2025

·endpts.com

Lantheus to buy radiopharma CDMO and diagnostic assets for $250M upfront

In its latest move to expand its portfolio, Lantheus Holdings is spending $250 million upfront to buy radiopharma CDMO and diagnostics company Evergreen Theragnostics, which could also receive up to $752.5 million in future milestone payments. The deal will bolster Lantheus’ manufacturing for future commercial launches and remove any risks using third-party CDMOs, the company said in a Tuesday release. The production of radiopharmaceuticals is complicated , as companies grapple with isotope shortage issues and many have boosted their internal production footprints . Lantheus has been making moves to expand its business, including its $350 million purchase of Life Molecular Imaging earlier this month to boost its diagnostics portfolio. Massachusetts-based Lantheus will take over Evergreen’s manufacturing site in Springfield, NJ and its neighboring office, a discovery laboratory in Cranbury, NJ, and a clinical research site in Basel, Switzerland. Lantheus’ existing footprint includes at least one site in North Billerica, MA. Further, Lantheus is taking on Evergreen’s diagnostic agent, dubbed EVG-001, which is under FDA evaluation as an imaging agent for neuroendocrine tumors. It complements Lantheus’ generic version of Novartis’ Lutathera, called PNT2003, that it filed for FDA approval earlier this month. PNT2003 is being evaluated as a treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Lantheus will also gain the rest of Evergreen’s pipeline . This includes a diagnostic agent for small cell lung cancer in a mid-stage study, as well as three preclinical imaging agents for glioblastoma and pancreatic and lobular breast cancers. Evergreen also has a Phase 1 therapeutic candidate for small cell lung cancer and three other preclinical therapeutic cancer assets. In April 2024, Evergreen raised $26 million to boost its manufacturing capabilities as well as advance its assets into clinical trials.

Diagnostic ReagentsPhase 1

28 Jan 2025

·endpts.com

ITM aims to compete with Novartis after Phase 3 radiopharma win

ITM Isotope Technologies Munich plans to seek approval for its β-emitting radioligand in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) following a Phase 3 success, the biotech said Tuesday . Treatment with ITM-11 prolonged progression-free survival compared with everolimus, a standard of care for the rare cancer, according to topline data from the COMPETE study. However, another radiotherapy, Novartis’ Lutathera, is already approved in this population and ITM might have a hard time competing with the much larger company. ITM-11 is a somatostatin analog called edotreotide conjugated to lutetium-177. Lutathera is a different somatostatin analog, dotatate, linked to the same isotope. COMPETE is one of two Phase 3 trials of ITM-11. The open-label study recruited 309 patients with inoperable, progressive grade 1 or grade 2 GEP-NETs. The actual PFS figures from the trial have not been released, but if ITM-11 is approved in this setting — and the German biotech intends to file this year — it will compete with Novartis’ product, so it must at least match Lutathera’s performance. Lutathera was approved in second-line GEP-NETs on the strength of a 79% cut in the risk of progression or death versus control. But the control group in that trial received octreotide, not everolimus, so it is hard to know how great a reduction ITM-11 might need to show to have a good shot at approval. ITM-11 was well-tolerated in COMPETE, with “favorable” safety results, ITM said. Secondary endpoints, including objective response rate, overall survival and quality of life measures, are being evaluated. These and the key PFS number could come later this year. A second pivotal trial of ITM-11 in first- or second-line GEP-NETs, COMPOSE, could generate results in 2027. In a trial in the first-line GEP-NETs setting, Lutathera cut the risk of progression or death by 72%.

Phase 3OligonucleotideDrug ApprovalClinical Result

100 Deals associated with Lutetium Dotatate LU-177

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V10XX04	DB13985

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Neuroendocrine Tumors	CA	Advanced Accelerator Applications USA, Inc.	09 Jan 2019
Gastro-Enteropancreatic Neuroendocrine Tumor	US	Advanced Accelerator Applications USA, Inc.	26 Jan 2018
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	EU	Advanced Accelerator Applications SA	26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	IS	Advanced Accelerator Applications SA	26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	LI	Advanced Accelerator Applications SA	26 Sep 2017
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	NO	Advanced Accelerator Applications SA	26 Sep 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Neuroendocrine Neoplasm	Phase 3	CN	Sinotau Pharmaceutical Group	01 Jun 2024
Advanced Pancreatic Neuroendocrine Tumor	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Jul 2023
Carcinoid Tumors, Intestinal	Phase 3	US	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	BE	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	FR	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	DE	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	IT	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	PT	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	ES	Advanced Accelerator Applications SA	06 Sep 2012
Carcinoid Tumors, Intestinal	Phase 3	GB	Advanced Accelerator Applications SA	06 Sep 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03972488 (NETTER-2, CTgov)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	226	30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)+2.5% Lys-Arg sterile amino acid solution+Lutathera (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm))	tqiomzignn(gztcezlvuw) = geguaoqkvy jqakkpmbuy (cjimjwemvv, peukbputll - btyrhofrox) View more	-	10 Oct 2024
				High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm))	tqiomzignn(gztcezlvuw) = cxxgnesdfe jqakkpmbuy (cjimjwemvv, bseoqqyrhj - kamzqfuixx) View more
Biospace Manual	Phase 2	Meningioma	20	Lutathera	nogelfyhbf(rtckrxhgxa) = zxqqlscrcp lnnqrhvjja (njxzgaudkz ) View more	Positive	30 Sep 2024
EANM2024	Not Applicable	Neuroblastoma	23	Lu-177 DOTATATE	jpqmzcqpae(suibfvptjn) = gpglrsxuky bcrtxmmxdd (bsglpydbia ) View more	Positive	27 Sep 2024
Lu-177 DOTATATE (EANM2024)	Not Applicable	Paraganglioma \| Pheochromocytoma increased somatostatin receptor (SSTR) expression	26	2-4 courses of Lu-177 DOTATATE	grrjewcbdo(xvfzmuvltv) = wesockhwsn nocsywpukf (pllggjelve ) View more	Positive	27 Sep 2024
				≥5 courses of Lu-177 DOTATATE	zuhcgipjuv(dglusqycpe) = urwogqlbyv awtgkemamg (hsjvffigbm ) View more
EANM2024	Not Applicable	Neuroendocrine Tumors	-	[177Lu]- DOTA-TATE	oaqlzvbcrp(fmmbeivnsw) = RR-PRRT-associated AEs (grade 3-4) included thrombocytopenia (12.9%), lymphopenia (9.7%), anemia (6.5%), and leukopenia (3.2%). Importantly, no nephrotoxicity was observed during RR-PRRT. ishdkvxpac (swbirdhgko )	Positive	27 Sep 2024
NCT04086485 (Phase 1 Trial of Lu-177-DOTATATE in Combination with Olaparib, EANM2024)	Phase 1/2	SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor SSTR+	11	Lu-177-DOTATATE 200 mCi	sqdsohzmlw(guhsomlgzs) = niwqvknjzf szcchcnndq (hxeugegcvk ) View more	Positive	27 Sep 2024
				Olaparib 50mg	sqdsohzmlw(guhsomlgzs) = dzxyurzpiq szcchcnndq (hxeugegcvk ) View more
EANM2024	Not Applicable	Gastrointestinal Neoplasms	36	[177Lu]Lu-DOTA-TATE (Ileal NET)	isjnwgmzqt(osmbqcquam) = hkdxlfqzct tiijgftnqb (jnmolaibjq ) View more	Positive	27 Sep 2024
NCT04086485 (EANM2024)	Phase 1/2	Neuroendocrine Tumors SSTR	11	Lu-177-DOTATATE + Olaparib	ynhltmpmng(ptcdmjitui) = oabzmnrhfy soxkibypja (orwnshswiu, 0.77 - 248.85)	Positive	27 Sep 2024
ESMO2024	Not Applicable	-	-	90Y DOTA-TATE	gfaxemzkzf(livkgugoll) = efvbtgxoju iwjbgtqziu (kyzuqgnvxr, 40 - 100.4) View more	-	16 Sep 2024
				177Lu DOTA-TATE	gfaxemzkzf(livkgugoll) = bmpvavlyyn iwjbgtqziu (kyzuqgnvxr, 40 - 100.4) View more
NCT03972488 (ESMO2024)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	-	[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)	xzqlfyzclg(mqacvortkq): OR = 10.43 (95% CI, 3.98 - 27.29), P-Value = <0.1 View more	-	13 Sep 2024
				octreotide 60 mg LAR

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