A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a leading cause of End Stage Kidney Disease (ESKD) worldwide. Elevated levels of 3', 5' - cyclic AMP (cAMP) play a central role in the pathogenesis and progression of the disease. Vasopressin antagonists and somatostatin analogues, which indirectly reduce adenyl cyclase 6 activity, have been found to markedly reduce renal tubular cell proliferation and cyst growth in experimental models of ADPKD. In combination, the two treatments show a clear additive effect and may significantly reduce renal cystic and fibrotic volume as well as cAMP levels to wild type levels.
The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar renoprotective effect also in human disease.
Both medications effectively slow total kidney and cystic volume (TKV and TCV, respectively) growth and glomerular filtration rate (GFR) decline in patients with ADPKD. The short-term effect of both medications appear to be larger when the GFR is normal or even higher than normal and kidney volumes are still relatively stable. On the basis of experimental data, it is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human disease, during initial treatment as well as in the long-term. To address the working hypothesis of an additional short-term effect of Tolvaptan and Octreotide, we propose to run a pilot, explorative, randomized, placebo-controlled, clinical trial with a Cross-Over Design to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR combination therapy on TKV as assessed by MRI, and on GFR as directly measured by the iohexol plasma clearance technique in ADPKD patients with normal (80 to 120 ml/min/1.73m2) kidney function or even kidney hyperfiltration (GFR ≥120 ml/min/1.73m2).

Start Date12 Dec 2018

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

[+1]

NCT03057509

/ WithdrawnPhase 1IIT

A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors

This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.

Start Date01 Nov 2018

Sponsor / Collaborator

The General Hospital Corp.

NCT02874326

/ Unknown statusPhase 2IIT

An Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal Bleeding

The purpose of this study is to determine whether long-acting octreotide is safe and effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).
The study hypothesis is that octreotide is safe and will reduce transfusion requirements and endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal telangiectasias.

Start Date01 Oct 2016

Sponsor / Collaborator

Radboud University Medical Center

[+1]

100 Clinical Results associated with Octreotide depot (GP Pharm SA)

100 Translational Medicine associated with Octreotide depot (GP Pharm SA)

100 Patents (Medical) associated with Octreotide depot (GP Pharm SA)

416

Literatures (Medical) associated with Octreotide depot (GP Pharm SA)

30 Oct 2025·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Medical treatment in acromegaly: a network meta-analysis

Review

Author: Haidich, Anna-Bettina ; Ilie, Mirela-Diana ; Anagnostis, Panagiotis ; Raverot, Gérald ; Dekkers, Olaf M ; Kaparounaki, Chrysi ; De Alcubierre, Dario ; Goulis, Dimitrios G ; Isidori, Andrea M

Abstract:

Objective:

Acromegaly is a rare disorder caused by a growth hormone-secreting pituitary adenoma. Clinical trial evidence for its management is limited. This study compared medical treatments for acromegaly through a network meta-analysis, assessing biochemical and radiological responses.

Design:

A systematic review and network meta-analysis were conducted following the preferred reporting items for systematic reviews and network meta-analyses guidelines and Cochrane Handbook recommendations (PROSPERO registration: CRD42023364373).

Methods:

PubMed, Scopus, and Web of Science were searched up to June 2024. Included studies were randomized controlled trials and nonrandomized studies evaluating the efficacy or safety of acromegaly treatments. Primary outcomes were the percentage of adjusted insulin-like growth factor 1 (IGF-1) normalization and tumor shrinkage.

Results:

Twenty-seven studies, involving 4131 patients and 11 treatments were included. Pegvisomant was the best treatment for IGF-1 normalization, followed by pasireotide LAR. Both outperformed first-generation somatostatin receptor ligands (SRLs) combined with dopamine agonists (odds ratio [OR], 1.83; 95% CIs, 1.37-2.46 and OR, 1.46; 95% CIs, 1.02-2.08, respectively; I2 = 41%). Octreotide LAR was superior to oral octreotide capsules (OR, 5.41; 95% CIs, 1.89-15.52). For tumor shrinkage, pasireotide LAR was more effective than SRLs (n = 1059; OR, 11.47; 95% CIs, 1.5-87.64; I2 = 0%). Methodological heterogeneity may have affected comparability.

Conclusions:

Our findings suggest pasireotide LAR and pegvisomant as the most effective treatments for IGF-1 normalization. Pasireotide LAR was the best treatment for tumor shrinkage, though the evidence base was limited, requiring cautious interpretation. Their potential role as first-line options after surgery requires further research. Clinical decisions should consider cost, safety, and patient-specific parameters to optimize outcomes.

27 Oct 2025·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Surgical treatment and somatostatin experience in growth hormone-secreting pituitary macroadenoma due to novel AIP mutation

Article

Author: Bala, Keziban Aslı ; Eken, Emine Şeyma ; Kurnaz, Erdal ; Yılmaz, Şükriye ; Savaş Erdeve, Şenay ; Karacan Küçükali, Gülin ; Yeşil, Şule ; Sezer, Abdullah ; Keskin, Melikşah ; Karagöz, Kıymet ; Emrahoğlu, Muhammed Erkan ; Düzcan Kilimci, Duygu

Abstract:

Objectives:

Somatotropinomas are extremely rare in children and frequently associated with genetic causes. Among pituitary gigantism, approximately 30 % are attributed to the aryl hydrocarbon receptor-interacting protein ( AIP ) gene mutations, whereas other genetic causes are less common. These mutations cause more aggressive tumors that are challenging to control with a single intervention and often exhibit resistance to somatostatin analogs (SSAs). Our aim is to present a pediatric patient with a somatotropinoma due to a novel AIP variant who responded positively to SSA therapy following a single surgical intervention.

Case presentation:

A 15-year and 8-month-old male patient presented with complaints of excessive height and enlargement of the hands and feet over the past 2 years. Laboratory investigations revealed a random growth hormone level of 50 μg/L (normal range [NR]: 0.077–10.8) and insulin-like growth factor-1(IGF-1) level of 1,107 ng/mL (age-adjusted NR: 224–978/>+2 standardised deviation scores). Magnetic resonance imaging demonstrated a pituitary macroadenoma extending into the suprasellar region. A craniotomy was performed, and the majority of the tumor was resected. Due to the presence of residual tumor, SSA therapy (octreotide-LAR) was initiated. After 1 year of follow-up, IGF-1 levels returned to the normal range, and tumor growth was controlled. Genetic analysis identified a heterozygous frameshift novel variant (c.25delC, p.(Arg9Glyfs*9)) in the AIP gene.

Conclusions:

Although AIP mutation-positive cases are typically resistant to SSAs, our patient carrying a novel AIP variant demonstrated a favorable response to SSA treatment.

01 Aug 2025·EXPERIMENTAL AND CLINICAL ENDOCRINOLOGY & DIABETES

Experience with the Mixed Meal Test in Diagnosing GIP-Dependent Cortisol Hypersecretion at a Tertiary Center

Article

Author: Akturk, Mujde ; Altinova, Alev Eroglu ; Barlas, Tugba ; Sozen, Sinan ; Karakoç, Ayhan ; Poyraz, Aylar ; Yalcin, Mehmet Muhittin ; Cerit, Ethem Turgay ; Kayhan, Gulsum ; Toruner, Fusun Balos

Abstract:

Aberrant expression of glucose-dependent insulinotropic peptide receptors (GIPR) might regulate increased steroidogenesis in patients with ACTH-independent cortisol hypersecretion. This study investigated the presence of aberrant GIPR expression in patients with ACTH-independent cortisol hypersecretion and bilateral adrenal adenomas.Patients with bilateral adrenal adenomas, ACTH-independent CS and aberrant GIPR screened via mixed meal test were included. Patients’ demographic features and laboratory and imaging findings were obtained retrospectively.Twenty-one patients were included. Overt CS findings were present in 14.3% of the patients. One patient (4.7%) had a complete positive response (537% increase) and one patient (4.7%) had a partial response (41% increase) to the mixed meal test. In the remaining 19 patients, a mean change of -10.1% (range: −56.5% to+24.7%) in cortisol levels was observed at 120 min compared to baseline. The patient with a complete positive response was confirmed using 100 µg of IV octreotide. The patient underwent unilateral adrenalectomy after an inadequate long-term response to octreotide LAR therapy. The histopathology revealed bilateral macronodular adrenal cortical disease. We identified a germline heterozygous frameshift variant in the KDM1A gene in the patient’s blood sample and a recurrent deletion of the p arm of chromosome 1 harboring the KDM1A locus in the adrenal sample.These results may provide useful insights into the screening of aberrant GIPR expression in patients with ACTH-independent hypercortisolism. It is essential to further investigate which patients require screening. Moreover, a significant cortisol peak observed during the mixed meal test in the presence of these receptors has drawn attention.

News (Medical) associated with Octreotide depot (GP Pharm SA)

27 Nov 2025

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 27, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology (“ASH”) Annual Meeting taking place on December 6-9, 2025 in Orlando, USA. Results from a first-in-human study of the anti-CD47 monoclonal antibody HMPL-A83 in advanced solid tumors, as well as from the phase II part of the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma, will be presented at the ESMO Asia Congress 2025. Results from the phase II part of the phase II/III study of surufatinib in combination with camrelizumab and chemotherapy as a first-line treatment for metastatic pancreatic cancer will also be reported. Details of the presentations are as follows: Abstract titlePresenter/Lead authorPresentation detailsESMO Asia Congress 2025 - SPONSORED STUDIES A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumorsYe Guo (Shanghai, China)162MO | Mini Oral session: Developmental therapeutics and precision medicineSunday, December 7, 202511:40 - 11:45 SGTHall 407Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2Shanshan Wang (Shanghai, China)540O | Proffered Paper session: Genitourinary tumoursFriday, December 5, 202514:55 - 15:05 SGT Hall 402Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 studyShukui Qin (Nanjing, China)375P | Poster Display: Gastrointestinal tumours, non‑colorectalOsimertinib (osi) + savolitinib (savo) in EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) with MET overexpression and/or amplification (OverExp/Amp) following progressive disease (PD) on osi: SAVANNAH Asian subsetSe-Hoon Lee (Seoul, Korea)982P | Poster Display: Thoracic tumours, metastaticPatient-relevant Outcomes (PROs) from SACHI: a Phase 3 Trial of Savolitinib (Savo) plus Osimertinib (Osi) versus Chemotherapy (Chemo) in EGFR-mutant (EGFRm) and MET-amplified (METamp) Advanced NSCLC after Progression on EGFR-TKIsYongfeng Yu (Shanghai, China)984P | Poster Display: Thoracic tumours, metastaticAnalysis of MET Amplification (METamp) with FISH and NGS Method in SACHI TrialLonghua Sun (Nanchang, China)988P | Poster Display: Thoracic tumours, metastaticProgression pattern in patients (pts) with EGFR-mutant (EGFRm), MET-amplified (METamp) advanced NSCLC treated with savolitinib (savo) plus osimertinib (osi)Haiyan Yang (Changsha, China)1002P | Poster Display: Thoracic tumours, metastaticMET testing and treatment (tx) sequencing after progression of disease (PD) on first-line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Final analysis of a global real-world (rw) studyJulia Rotow (Boston, US)1005P | Poster Display: Thoracic tumours, metastatic ESMO Asia Congress 2025 - INVESTIGATOR-INITIATED STUDIES Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II TrialChen Zhang/ Yi Wang(Ningbo, China)205P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armGuanghai Dai/ Miaomiao Gou(Beijing, China)245eP | Poster Display: Gastrointestinal tumours, colorectalThe Efficacy and Safety of Fruquintinib (F) Plus FOLFIRI as Second-line (2L) Treatment in Bevacizumab (Bev)-pretreated RAS-mutated (RAS‑m) Metastatic Colorectal Cancer (mCRC)Zhenyang Liu/ Xiaolin Yang(Changsha, China)250eP | Poster Display: Gastrointestinal tumours, colorectalReal-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal CancerXiujuan Qu/ Lin Xu (Shenyang, China)255eP | Poster Display: Gastrointestinal tumours, colorectalMatching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine TumorsJianming Xu (Beijing, China)214P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label studyXubao Liu/ Ziyao Wang (Chengdu, China)400P | Poster Display: Gastrointestinal tumours, non‑colorectal Final analysis of long-term results of sovleplenib’s ESLIM-01 China Phase III study in in adult patients with chronic primary immune thrombocytopenia will be presented at the 2025 ASH Annual Meeting. Details of the presentation is as follows: Abstract titlePresenter/Lead authorPresentation details2025 ASH Annual Meeting - SPONSORED STUDIES Phase 3 ESLIM-01 study: Final analysis of efficacy and safety of long-term treatment with sovleplenib in adults with chronic primary immune thrombocytopeniaRenchi Yang (Tianjin, China)843 | Oral Abstract SessionMonday, December 8, 202515:15 - 15:30 EST Room OCCC - W304EFGH About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. About HMPL-A83 HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. HMPL-A83 blocks CD47 binding to Signal regulatory protein (SIRP) α and disrupts the “do not eat me” signal that cancer cells use to shield themselves from the immune system. HUTCHMED currently retains all rights to HMPL-A83 worldwide. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About Sovleplenib Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders. HUTCHMED currently retains all rights to sovleplenib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, the further clinical development for fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, its expectations as to whether any studies on fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as camrelizumab and osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

Phase 2ImmunotherapyClinical ResultLicense out/inPhase 3

06 Mar 2025

·firstwordpharma.com

ITM fleshes out data for Phase III radiopharma success in neuroendocrine tumours

A radiopharmaceutical from ITM Isotope Technologies Munich reduced the risk of disease progression or death by 33% versus Novartis' targeted molecular therapy Afinitor (everolimus) in patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The outcome of the Phase III COMPETE study was first top-lined in January, with the announcement marking one of only a handful of wins for a radiopharmaceutical in a head-to-head trial. Detailed results were presented Thursday at the European Neuroendocrine Tumor Society (ENETS) annual meeting.The trial compared ITM-11 (177Lu-edotreotide) with Afinitor in 309 patients with inoperable, progressive Grade 1 or 2 somatostatin receptor (SSTR)-positive GEP-NETs. According to ITM, approximately 15% of people in each trial arm were treatment naïve, with the remaining 85% or so having received one prior therapy.Results showed that median progression-free survival (PFS) for ITM's therapeutic was 23.9 months, which was significantly and clinically better than the 14.1 months for Afinitor. In comparison, in the Phase III NETTER-2 trial, Novartis' peptide receptor radionuclide therapy Lutathera (lutetium Lu 177 dotatate) reduced the risk of disease progression or death by 72% as a first-line therapy for patients with SSTR-positive well-differentiated Grade 2/3 advanced GEP-NETs versus high-dose octreotide LAR alone, with median PFS in the two arms of 22.8 months and 8.5 months, respectively.ITM told FirstWord that the choice of Afinitor as a comparator in COMPETE was "backed by scientific evidence of efficacy and high clinical acceptance after market authorisation." The company suggested that this decision set "a higher standard for meeting the primary endpoint in more advanced grade tumours," adding that it hopes "physicians will recognise the higher threshold of our study design."FDA filing this year"These successful results validate our decision to design a pivotal Phase III trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy," CEO Andrew Carey said. Based on the findings, ITM plans to seek approval of ITM-11 in the US this year; however, the company told FirstWord that it is "currently prohibited" from filing in Europe until 2029 due to orphan drug designation on Lutathera.Top-line results also showed that interim median overall survival (OS) was 63.4 months for ITM-11. That was numerically higher than the 58.7 months seen with Afinitor, but not statistically significant at the current analysis. ITM noted that patients were allowed to start an alternative therapy after disease progression, "potentially confounding" the OS data."These data show unequivocal support for [ITM-11's] potential benefit in extending PFS," remarked study investigator Jaume Capdevila, adding that the radiopharmaceutical's "convenient dosing schedule and favourable safety results reinforce its potential as a compelling new treatment option."In COMPETE, patients were treated with ITM-11 every three months for up to four cycles, or with Afinitor daily for up to 30 months, or until disease progression. Meanwhile, ITM's therapy was well tolerated, with treatment-emergent adverse events occurring at a rate of 82.5%, compared with 97% for Afinitor. However, there was one Grade 2 event of myelodysplastic syndrome in the ITM-11 arm.Growing optionsNeuroendocrine tumours are one of the few cancers that have so far benefited from the approval of radiopharmaceuticals. Novartis currently markets Lutathera as a treatment for SSTR-positive GEP-NETs, while Sanofi also has skin in the game, having reached a deal last year to join forces with RadioMedix and Orano Med on the radioligand medicine AlphaMedix (212Pb-DOTAMTATE).Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house. "Together, with our global isotopes manufacturing business, robust supply chain and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry," Carey said.ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.

Phase 3Clinical ResultOligonucleotideOrphan Drug

28 Jan 2024

·www.pharmaindustrial-india.com

Lutathera Breakthrough: 72 Percent Reduction in Gastroenteropancreatic Neuroendocrine Tumor Progression

Novartis has unveiled groundbreaking data from the Phase III NETTER-2 trial, revealing that Lutathera® plus long-acting release (LAR) octreotide has demonstrated a remarkable 72 percent reduction in the risk of disease progression or death as first-line therapy for patients with somatostatin receptor-positive (SSTR+) well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) compared to high-dose octreotide LAR alone. These findings were presented at the prestigious 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium. Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto, emphasized the practice-changing impact of these results, stating, "These positive results for Lutathera are practice-changing and offer new first-line treatment data for patients who have a significant unmet need." The trial's efficacy endpoints further underscore the superiority of Lutathera, with a progression-free survival hazard ratio of 0.28 and a median progression-free survival of 22.8 months, significantly outperforming high-dose octreotide LAR. Novartis Global Head of Oncology Development, Jeff Legos, hailed the trial as a milestone, noting, "This is the first positive Phase III trial of a radioligand therapy in the first-line setting, and the overall efficacy and safety results are amongst the most clinically relevant observed to date in this kind of advanced cancer." Legos stressed the significance of addressing the unmet needs of patients with newly diagnosed advanced GEP-NETs and reaffirmed Novartis' commitment to advancing radioligand therapies. The study reported no new or unexpected safety findings, aligning with the well-established safety profile of Lutathera. Notably, the most common adverse events for the Lutathera arm included nausea, diarrhea, and abdominal pain, with lymphocyte count decrease as the most common grade ≥3 adverse event. As the NETTER-2 trial continues, Novartis remains focused on evaluating secondary endpoints, including overall survival and long-term safety. The results mark a pivotal moment in the landscape of treating advanced GEP-NETs, offering hope for improved outcomes and further advancements in cancer care.

Phase 3Clinical ResultASCOOligonucleotide

100 Deals associated with Octreotide depot (GP Pharm SA)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB00104

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acromegaly	Spain	GP Pharm SA	-
Bleeding esophageal varices	Spain	GP Pharm SA	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Intestinal Obstruction	Phase 2	France	Novartis Pharmaceuticals Corp.	01 Sep 2005
Peritoneal Neoplasms	Phase 2	France	Novartis Pharmaceuticals Corp.	01 Sep 2005
Advanced Prostate Carcinoma	Phase 2	Italy	Novartis AG	01 Feb 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GI2025	Not Applicable	Gastric Neuroendocrine Tumor Adjuvant ki67	35	Somatostatin analogs (long-acting releasing octreotide 30 mg)	opzbjoepyp(tmxdnilckb) = gfxrwlvtki kudfsktqfx (qbpngdbqdi, 67 - NR)	Positive	23 Jan 2025
				Lanreotide 120 mg	opzbjoepyp(tmxdnilckb) = icsvlxcolz kudfsktqfx (qbpngdbqdi, 67 - NR)
NCT01538966 (CTgov)	Not Applicable	Acromegaly	76	Octreotide LAR+Lanreotide+Pegvisomant (High Dose SRL + Weekly Pegvisomant)	dvvtzwbppi(mnialzswah) = adxnfzhwpn nzkecijqin (ndarwzzxqg, 1,645.49) View more	-	04 Jan 2023
				Octreotide LAR+Lanreotide+Pegvisomant (Low Dose SRL + Daily Pegvisomant)	dvvtzwbppi(mnialzswah) = gcushvwnht nzkecijqin (ndarwzzxqg, 11,158.49) View more
ASCO_GI2018	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor First line \| Second line	273	Octreotide	ogvoakqifg(lysowabjkc) = etqynvdwbo cilfbidqmb (hdsbuuioip, 51%)	-	26 Feb 2018
Pubmed \| PLoS One	Phase 2	Thymus Neoplasms Neoadjuvant positive octreotide scans	17	Octreotide LAR	lxnxcrbipd(emrxyiqbdt) = 71% ecdhqgwhpt (kapbhluuip ) View more	Positive	16 Dec 2016
NCT01371643 (CTgov)	Phase 4	Pituitary Adenoma \| Acromegaly	41	Octreotide LAR (Medical Treatment by Octreotide LAR)	kxpearlmxw = ochqnyewqd fkfkogacbx (btbbkqknnz, hjchhnkoxj - yohkdhsiwq) View more	-	22 Jul 2016
				transsphenoidal surgery+Octreotide LAR (Surgical Debulking Followed by Octreotide LAR)	kxpearlmxw = bufrxweocn fkfkogacbx (btbbkqknnz, afviogujck - jnbxtmvcus) View more
ASCO2015	Not Applicable	Neuroendocrine Tumors	-	Octreotide LAR	aorugnqwun(jkcmwxxtfw) = uorxiqrmvx vntdcltfxd (larcdxkfib ) View more	-	20 May 2015
ASCO_GI2015	Not Applicable	Neuroendocrine Tumors	214	Octreotide LAR (Group A)	liwtzjlisp(foqpllhket) = npiysqvihb vvbsvbxzlb (eckrdgsfbx, 13.2–31.5)	-	20 Jan 2015
				Octreotide LAR (Group B)	liwtzjlisp(foqpllhket) = qpwbudpoqs vvbsvbxzlb (eckrdgsfbx, 20.5–51.1)
ASCO2014	Not Applicable	Neuroendocrine Tumors	-	Octreotide LAR (OCT-L)	kzcpfkazpz(qwyjwhfdqv) = wuvgutcdnr darbnfxpoc (szmxktugwl )	-	20 May 2014
				No OCT-L	kzcpfkazpz(qwyjwhfdqv) = zvigdviqdt darbnfxpoc (szmxktugwl )
ASCO2014	Phase 3	Advanced Neuroendocrine Neoplasm	254	Octreotide LAR	dbruidooax(punyjazmnc) = xtmlrkpqwc hqkskupgon (izbrhzwetk, 32 - 52)	-	20 May 2014
NCT00108355 (CTgov)	Phase 4	Fibrosis \| Ascites	29	Oral tablet (Midodrine placebo)	iwpynixewn(gzbacbazgn) = pxnxmliwqb flcswekuey (cyktugitmb, wskpvxcijd - hpnyhfadbg) View more	-	06 Mar 2014

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