Somatuline Depot (lanreotide prolonged-release subcutaneous) / Ipsen, Teijin - LARVOL DELTA

A REAL-WORLD STUDY OF LANREOTIDE AUTOGEL FOR THE TREATMENT OF PATIENTS WITH ACROMEGALY IN CHINA: BASELINE INTERIM ANALYSIS (ESPE-ESE 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Acromegaly • Endocrine Disorders

Subcutaneous Lanreotide Depot: A Diagnostic Pitfall in Neuroendocrine Tumor Imaging. (PubMed, Cureus) - "A retrospective review of a CT scan taken two months after treatment initiation revealed that these nodules were already present and had gradually increased in number, allowing for their correct identification as persistent lanreotide depots. This case underscores the need for heightened diagnostic awareness to prevent unnecessary interventions and ensure accurate management."

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

RIALTO: Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors (clinicaltrials.gov) - P3 | N=166 | Not yet recruiting | Sponsor: Grupo Espanol de Tumores Neuroendocrinos

New P3 trial • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA) (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Antonio Fojo | Recruiting ➔ Active, not recruiting | N=40 ➔ 10 | Trial completion date: Dec 2023 ➔ Mar 2026 | Trial primary completion date: Dec 2023 ➔ Mar 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • CNS Tumor • Endocrine Cancer • Oncology • Solid Tumor • SSTR

Pharmac funds medicines for liver, ovarian, and neuroendocrine cancers (PHARMAC) - "People with liver, ovarian, and neuroendocrine cancers will have access to more medicines from 1 March 2025. Pharmac will fund: atezolizumab and bevacizumab for liver cancer that can’t be removed by surgery; bevacizumab for advanced ovarian cancer; lanreotide for neuroendocrine cancers, bowel blockages caused by cancer, and for a growth disorder called acromegaly....Ngawati says that funding atezolizumab and bevacizumab is a significant milestone for some people with liver cancer in New Zealand."

Reimbursement • Hepatocellular Cancer • Neuroendocrine Carcinoma • Ovarian Cancer

Phase Ib/II study of Pembrolizumab with Lanreotide depot for advanced, progressive Gastroenteropancreatic neuroendocrine tumors (PLANET). (PubMed, J Neuroendocrinol) - "We conclude that immune checkpoint blockade had low activity in unselected patients with grade 1 and 2 GEP-NETs. Further study of strategies to reduce Treg activation or enhance effector memory activation during immunotherapy is warranted."

IO biomarker • Journal • P1/2 data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • PD-L1

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula (clinicaltrials.gov) - P3 | N=274 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • Hepatology • Oncology • Solid Tumor

Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China (clinicaltrials.gov) - P=N/A | N=129 | Completed | Sponsor: Ipsen | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Acromegaly • Endocrine Disorders • IGF1

AIM-NETs: Asian Investigation of Lanreotide Autogel® in the Management of GEP-NETs (clinicaltrials.gov) - P=N/A | N=71 | Completed | Sponsor: Asan Medical Center | Recruiting ➔ Completed

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

Adjuvant therapy with somatostatin analogs for recurrent gastric neuroendocrine tumors type 1. (ASCO-GI 2025) - "All pts received adjuvant therapy with SA, 33 (94.3%) long-active releasing octreotide 30 mg and 2 (5.7%) lanreotide 120 mg every 4 weeks... Adjuvant treatment with SA significantly improved DFS and should be considered for recurrent and multifocal gNETs type 1. Duration of therapy ≥12 months was significantly associated with improvement in DFS compared with shorter duration of therapy."

Clinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • GAST

IGF-I levels during standard Lanreotide dose predicts biochemical outcome of high-frequency regimen in acromegaly. (PubMed, Pituitary) - "Our results demonstrated that initial IGF-I levels during SD-Lanreotide predicted the biochemical outcome after 12 months of HF-Lanreotide. Patients in whom HF-Lanreotide did not normalize IGF-I after 6 months of treatment remained uncontrolled 12 months after starting this regimen."

Journal • Retrospective data • Acromegaly • Endocrine Disorders • IGF1 • SSTR

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: Debiopharm International SA | Active, not recruiting ➔ Terminated; The recruitment was halted for strategic reasons

Trial termination • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

SORENTO: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET (clinicaltrials.gov) - P3 | N=332 | Active, not recruiting | Sponsor: Camurus AB | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

Pachydermoperiostosis Due to a Novel HPGD Splicing Site Mutation Masquerading as Acromegaly. (PubMed, JCEM Case Rep) - "Reverse transcription polymerase chain reaction confirmed that this variant led to defective splicing with skipping of exon 6, a frameshift, and truncation at codon 13 of exon 7 downstream. His symptoms did not respond well to nonsteroidal anti-inflammatory drugs but showed excellent response to a trial of lanreotide autogel that has been used for about 1 year."

Journal • Acromegaly • Endocrine Disorders • Oncology • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Debiopharm International SA | N=30 ➔ 20

Enrollment change • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

Hydroxypropyl β Cyclodextrins Effects on Self-Assembly of Cyclic Peptide, Lanreotide Acetate, in Water and Subsequent Release rate from an in vitro Emulator of Subcutaneous Delivery. (PubMed, J Pharm Sci) - "This complexation also alters the viscosity behavior of lanreotide from non-Newtonian under low shear rates to Newtonian solution. Furthermore, the lanreotide/ HPβCyD inclusion complex reduces interactions with hyaluronic acid in the subcutaneous environment, leading to significant improvement in the release rate of lanreotide acetate at high concentrations (above 3% w/w in water)."

Journal • Preclinical

SUNLAND: a randomized, double-blinded phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumors. (PubMed, Ther Adv Med Oncol) - P1 | "In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0-1 were randomly assigned 1:1 to receive 37.5 mg sunitinib or a placebo, combined with 120 mg lanreotide autogel every 28 days. While we cannot entirely rule out the efficacy of sunitinib, lanreotide alone may play a significant role. EudraCT: 2012-001098-94."

Clinical • Journal • Metastases • P2 data • Cardiovascular • Endocrine Cancer • Hypertension • Neuroendocrine Tumor • Oncology • Solid Tumor

β-Cyclodextrin Derivatives Bind Aromatic Side Chains of the Cyclic Peptide Lanreotide. (PubMed, J Pharm Sci) - "In this study, the inclusion complexes of cyclic peptide drug lanreotide acetate with two common β-cyclodextrin derivatives, Sulfobutyl ether β-CD (SBEβ-CD) and hydroxypropyl β-CD (HPβ-CD) were investigated...Docking studies suggested that the 1:1 inclusion complex is more favorable than higher order complexes due to the steric hindrance and size considerations. The docking analysis indicated the stable conformation of all three aromatic side chains with both β-cyclodextrin derivatives, SBEβ-CDand HPβ-CD."

Journal

Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. (PubMed, J Clin Endocrinol Metab) - P3 | "CAM2029 provides a convenient and effective treatment option for acromegaly, with superior biochemical control versus placebo. Symptom control, QoL and satisfaction were improved from baseline SoC."

Clinical • Journal • P3 data • Acromegaly • Endocrine Disorders • IGF1

Long-term experience with octreotide and lanreotide for the treatment of gastroenteropancreatic neuroendocrine tumors. (PubMed, Clin Transl Oncol) - "Our long-term experience with octreotide and lanreotide in NET did not reveal differences in antitumor effectiveness. This is consistent with previous reports and might suggest that both SSA can be used interchangeably if needed."

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

Biochemical and radiological efficacy of systmic lanreotide therapy of patients with advanced, unresectable, non-metastatic paraganglioma/pheochromocytoma (PPGL) sporadic and hereditary (ESMO 2024) - "Lanreotide autogel therapy is effcient in reducing TGR in all subjects. TGR reduction is seen in a group of secretory tumors, hereditary syndromes and also female and multiple lesions. Lanreotide did not block over-secretion of metoxycatecholamines in secretory tumours, most of the subjects developed metabolic further progression."

Clinical • Metastases • CNS Tumor • Endocrine Cancer • Oncology • Solid Tumor • SDHB

Real-World Study of Lanreotide Autogel in Routine Practice in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Hong Kong and Taiwan. (PubMed, Oncol Ther) - "Lanreotide autogel was well tolerated and showed good tumor control rate in a real-world setting. These findings align with results from previous studies in Caucasian, Japanese, and Korean patients, thus supporting lanreotide autogel for treating patients with GEP-NETs of Chinese ethnicity."

Journal • Real-world • Real-world evidence • Endocrine Cancer • Hepatology • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Medical treatment of acromegaly - When the tumor size matters: A narrative review. (PubMed, Growth Horm IGF Res) - "Therefore, an individual approach is necessary in the treatment of patients with acromegaly, based on repeated insight to their clinical, biochemical, pathological and imaging characteristics. In this review, we summarize and comment how pituitary tumor size is affected by the treatment with all currently available drugs in acromegaly: long-acting somatostatin receptor ligands of the first generation (octreotide LAR and lanreotide autogel) and the second generation (pasireotide-LAR), as well as pegvisomant (PEG) and cabergoline (CAB)."

Journal • Review • Acromegaly • Endocrine Cancer • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • IGF1 • SSTR

Lanreotide versus placebo for tumour reduction in patients with a 68Ga-DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma (GALANT study): a randomised, multicentre, phase 3 trial with blinded outcome assessment. (PubMed, Lancet Reg Health Eur) - P3 | "A predefined sample of 44 patients with PET-positive NFPMA were randomly assigned (1:1) to lanreotide acetate 120 mg or placebo, both administered as deep subcutaneous injections every 28 days for 72 weeks...Compared with placebo, lanreotide treatment did not reduce tumour size or growth in patients with 68Ga-DOTATATE PET-positive NFPMA. Ipsen Farmaceutica BV."

Journal • P3 data • Gastrointestinal Disorder • Oncology • Pituitary Gland Carcinoma • SSTR

Grade 3 Pancreatic Neuroendocrine Tumor Refractory to Chemotherapy Successfully Treated with Peptide Receptor Radionuclide Therapy Leading to Conversion Surgery. (PubMed, Intern Med) - "A 59-year-old woman was diagnosed with a pancreatic neuroendocrine tumor (P-NET; Grade 3, Ki67: 25%) with multiple liver and lymph node metastases and started chemotherapy with streptozosin (500 mg/m2/day) in combination with lanreotide acetate (120 mg)...As PRRT was remarkably successful and the tumor shrank, surgery was performed to resect the primary pancreatic tumor, liver metastases, and lymph node metastases. CT evaluation performed six months after the surgery showed a complete response."

Journal • Surgery • Endocrine Cancer • Gastrointestinal Cancer • Hepatology • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor