Signifor LAR (pasireotide long acting release) / Recordati - LARVOL DELTA

Indirect Treatment Comparison of Biochemical Control Between Pasireotide Long-Acting Release and Pegvisomant as Second-Line Therapies for Acromegaly, Based on Real-World Evidence (ISPOR-EU 2025) - "This meta-analysis of RWE suggests similar efficacy in normalizing IGF-1 levels between PAS LAR and PEG in the second-line treatment of acromegaly. Further ITCs are planned to assess other comparative outcomes in real-world clinical practice, including tumour response, quality of life, treatment safety and discontinuation."

Clinical • HEOR • Real-world • Real-world evidence • Acromegaly • Endocrine Disorders • IGF1 • SSTR

Medical treatment in acromegaly: a network meta-analysis. (PubMed, Eur J Endocrinol) - "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."

Journal • Retrospective data • Acromegaly • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma • Rare Diseases • IGF1

Long-Term Antitumour Effects of Pasireotide in Acromegaly. (PubMed, Eur J Endocrinol) - "Pasireotide appears to induce durable cystic degeneration in somatotroph tumours, with evidence suggesting sustained antitumor effects that may extend beyond treatment discontinuation. These findings support its potential for a broader therapeutic role, warranting validation in future prospective studies."

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

Pasi-Bone: Effects of Pasireotide Lar Therapy on Bone Metabolism (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

New trial • Acromegaly • Endocrine Disorders • Pituitary Gland Carcinoma

The Combination Therapy of Pasireotide LAR Plus Pegvisomant and Cabergoline Relieved Acromegaly-Related Headache in a Female Patient with AIP-Mutated Acromegaly: A Case Report. (PubMed, Endocr Metab Immune Disord Drug Targets) - "This case report highlights the potential benefits of pasireotide in the treatment of refractory headaches, particularly when combined with pegvisomant.  ."

Journal • Acromegaly • Endocrine Disorders • Pain • Pituitary Gland Carcinoma • IGF1 • SSTR

Long-Term Safety of Pasireotide in Patients With Cushing's Disease: Final Results From a 10-Year Open-Label Phase IV Rollover Study (B2412) (ENDO 2025) - P4 | "Data are reported for CD pts from 4 parent studies who received pasireotide long-acting release (LAR; n=33) or subcutaneous (sc; n=29) and ≥1 dose during the rollover (except for 1 pt who only received pasireotide sc in the parent study). Pasireotide is a well-tolerated long-term treatment option for CD pts, with pts having received treatment for ≤16 years from parent study entry. Few pts discontinued because of AEs, including hyperglycemia, and hyperglycemia was infrequent during the study."

Clinical • P4 data • Acromegaly • Back Pain • Colon Cancer • Colorectal Cancer • Cushing’s Disease • Diabetes • Endocrine Disorders • Gastroenterology • Hypoglycemia • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Oncology • Pain • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor • SSTR

Impact of pasireotide on lipid and glucose metabolism in patients with acromegaly: a systematic review and meta-analysis. (PubMed, J Endocrinol Invest) - "In this large meta-analysis, PasiLAR was associated with increased HDL-C, FPG, HbA1c, and frequency of DM in patients with acromegaly. There was no effect on triglycerides, total cholesterol, and LDL-C."

Journal • Retrospective data • Review • Acromegaly • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders

Cardiac Remodelling and Function in a pituitary-specific Aip-knockout Acromegalic Mouse Model: Impact of First- and Second-Generation Somatostatin Analogues. (ESPE-ESE 2025) - "We treated 3-month-old KO-mice with monthly subcutaneous long-acting octreotide (30µg/g), pasireotide (60µg/g) or vehicle injections for 4 months... Pituitary-specific Aip -KO mice develop significant LV hypertrophy and fibrosis, mimicking human ACM. While pasireotide better reduces IGF-1 and weight, octreotide provides superior cardioprotection, suggesting a direct benefit beyond IGF-1 suppression."

Late-breaking abstract • Preclinical • Cardiomyopathy • Cardiovascular • Fibrosis • Immunology • IGF1 • SSTR

Pasireotide Induces Long-term Cystic Degeneration of Somatotrophic Pituitary Neuroendocrine Tumors (PitNETs) (ESPE-ESE 2025) - "Background: Pasireotide LAR is a long-acting somatostatin analog with potential antitumor activity, as demonstrated by treatment induced increased MRI T2-signal intensity of somatotrophic PitNETs (1), but long- term follow-up data are lacking. Forty-four patients, 43 % female, median (IQR) age 52 (15 years) were included. Median treatment duration was 31.0 months. The median IR of the PitNETs increased between baseline and MRI at 7 years (1.09 vs."

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

TREATMENT-RESISTANT GH-SECRETING PITUITARY ADENOMA IN YOUNG PATIENT HARBORING A VARIANT SOMATIC MUTATION OF THE GNAS GENE: A CASE REPORT (ESPE-ESE 2025) - "A second transsphenoidal surgery and monthly octreotide LAR (20–60 mg) failed to achieve biochemical control, with a nadir GH of 5.42 ng/mL and IGF-1 of 602 ng/mL. Pasireotide LAR and bromocriptine were administered, but GH levels fluctuated between 1.79–7.15 ng/mL and IGF-1 remained at 555–575 ng/mL...Pegvisomant was considered but unavailable... We report a treatment-resistant GH-secreting pituitary adenoma in a pediatric patient harboring a somatic GNAS mutation. Managing such cases remains challenging, particularly in children. Stereotactic or proton radiotherapy should be considered when surgery and medical therapy fail to achieve biochemical control."

Case report • Clinical • Pain • Pediatrics • Pituitary Gland Carcinoma • GNAS • IGF1 • SSTR

Long-term safety of pasireotide in patients with acromegaly: Final results from a 10-year open-label Phase IV rollover study (B2412) (ESPE-ESE 2025) - P4 | "Here, we report data from the final analysis in patients with acromegaly who received pasireotide long-acting release (LAR) during the rollover. Pasireotide is a well-tolerated long-term treatment option for patients with acromegaly, with patients having received treatment for ≤17 years from parent study entry. Hyperglycaemia was infrequent, and AEs, including hyperglycaemia, were mostly manageable without treatment discontinuation during the rollover."

Clinical • P4 data • Acromegaly • Back Pain • Cardiovascular • Congestive Heart Failure • Cushing’s Disease • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Heart Failure • Hypertension • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Pulmonary Embolism • Respiratory Diseases • SSTR

A Case of Aggressive AIP-Mutated Pituitary Acrogigantism Treated with Pasireotide. (ESPE-ESE 2025) - "Due to his hyperprolactinemia, cabergoline was started and rose to a dose of 0.5-1.0 mg/day. Pasireotide long-acting release treatment may be beneficial in AIP mutated patients with acrogigantism and positive immunohistochemical staining of tumour cells for SSTR5."

Clinical • Acromegaly • Anorexia • Back Pain • Cardiovascular • Endocrine Cancer • Endocrine Disorders • Musculoskeletal Pain • Neuroendocrine Tumor • Oncology • Ophthalmology • Pain • Pituitary Gland Carcinoma • Rare Diseases • Solid Tumor • IGF1 • SSTR2 • SSTR5

A persistent headache in acromegalic patient: the positive result of combination therapy with pasireotide LAR, pegvisomant and cabergoline. (ESPE-ESE 2025) - "Pasireotide is known to be able to improve symptoms not sufficiently controlled by fg-SRLs and it can be used as monotherapy or in combination therapy in patients with severe headache not responsive to first-generation SRL therapy, as reported in several studies. Our case report enforces knowledge about pasireotide benefits in headache treatment."

Clinical • Combination therapy • Acromegaly • Endocrine Disorders • Epilepsy • Pain • Pituitary Gland Carcinoma • Ventriculomegaly • IGF1

Impact of Pasireotide LAR on Lipid and Glucose Metabolism in Patients with Acromegaly: a Systematic Review and Meta-analysis (ESPE-ESE 2025) - "This systematic review and meta-analysis is the first comprehensive evaluation of the effects of PasiLAR treatment on both lipid and glucose metabolism in patients with acromegaly. Treatment with PasiLAR for at least 6 months was associated with increased HDL-C, FPG, HbA1c, and frequency of diabetes mellitus in patients with acromegaly. These findings are novel and emphasize the importance of a personalized approach to the treatment of acromegaly with a careful examination of metabolic status, to prevent impairment of lipid and glucose metabolism."

Retrospective data • Review • Acromegaly • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders • SSTR

Real-World Experience with Pasireotide-LAR in Cushing's Disease: Single-Center 12-Month Observational Study. (PubMed, J Clin Med) - " Pasireotide-LAR is an effective alternative treatment in selected patients with CD. Pasireotide-LAR is overall safe and well tolerated, with hyperglycemia being the most common but manageable adverse event."

Journal • Observational data • Real-world evidence • Cushing’s Disease • Diabetes • Endocrine Cancer • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma

Efficacy and safety of Pasireotide in Insulinoma-associated hypoglycemia: a Systematic Review. (PubMed, J Clin Endocrinol Metab) - "Pasireotide effectively restored glucose levels in insulinoma patients who failed prior treatments. However, its efficacy was lower in aggressive insulinomas, emphasizing the need for alternative or combinatory strategies in metastatic cases. Given that Pasireotide was never used as a first-line therapy in the reviewed cases, earlier administration in selected patients may improve outcomes."

Journal • Diabetes • Hypoglycemia • Oncology • Solid Tumor

Real-world evidence of effectiveness and safety of pasireotide in the treatment of acromegaly: a systematic review and meta-analysis. (PubMed, Rev Endocr Metab Disord) - "Pasireotide long-acting release (PAS-LAR) is a second-generation somatostatin receptor ligand (SRL) approved for acromegaly treatment. These findings suggest that PAS-LAR is an effective option for acromegaly patients resistant to fgSRL, but careful monitoring of glucose levels is essential. The high heterogeneity observed across studies emphasizes the need for identifying PAS-LAR response biomarkers to set-up individualized treatment approaches for optimizing patient outcomes."

HEOR • Journal • Real-world • Real-world evidence • Retrospective data • Review • Acromegaly • Diabetes • Endocrine Disorders • Metabolic Disorders • Oncology • Pituitary Gland Carcinoma • Type 2 Diabetes Mellitus • IGF1 • SSTR

Cost-Effectiveness of Pasireotide Long-Acting Release in Acromegaly: Systematic Literature Review (ISPOR-EU 2024) - "PAS LAR was compared with pegvisomant (PeGV), SSA, and PeGV+SSA in 2 nd line medical treatment. PAS LAR offers comparable health benefits to SSA + PeGV and PeGV monotherapy at a lower therapy cost. With PAS LAR generating additional QALY, cost-effectiveness vs. SSA depends on the adopted willingness-to-pay threshold."

Cost effectiveness • HEOR • Review • Acromegaly • Endocrine Disorders • IGF1

GH receptor polymorphisms guide second-line therapies to prevent acromegaly skeletal fragility: preliminary results of a pilot study. (PubMed, Front Endocrinol (Lausanne)) - "A longitudinal, retrospective, observational study was conducted on a cohort of 45 acromegalic patients not-responsive to first-generation somatostatin receptor ligands (fg-SRLs) and treated with GHR antagonist (Pegvisomant) or with the second-generation SRLs (Pasireotide long-acting release). Our data support a predictive role of the GHR isoforms for the occurrence of i-VFs in acromegalic patients treated with second-line drugs, tailored to the individual patient. The knowledge of the GHR polymorphism may facilitate the choice of second-line therapies, improving the therapeutic approach, in the context of personalized medicine."

Journal • Acromegaly • Endocrine Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • SSTR

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

Long-term Remission in Functioning Pituitary Adenomas after Medical Therapy Withdrawal: A Chance for Cushing's Disease. (PubMed, Endocr Metab Immune Disord Drug Targets) - "Far from the general rule, this case suggests that prolonged treatment with pasireotide LAR might induce a durable CD remission. A dose down-titration/suspension might be considered in patients well-controlled on long-term therapy and with negative pituitary imaging. However, close monitoring is recommended given the high rate of complications in untreated patients."

Journal • Cushing’s Disease • Endocrine Cancer • Endocrine Disorders • Oncology • Pituitary Gland Carcinoma

Somatostatin analogues treatment in a patient suffering from a sporadic bifocal RET-negative medullary thyroid cancer with extended extrathyroidal spread after three surgical interventions. (ETA 2024) - "A first-generation somatostatin analogue (SSA) treatment was decided with monthly Octreotide LAR 30mg since an increase of calcitonin to 371pg/ml was observed...Then medical therapy with monthly Pasireotide LAR 60mg was initiated and 5 months later (10/2023) the calcitonin levels dropped at 261pg/ml. An antidiabetic therapy was also initiated, probably as side effect of the drug. Somatostatin analogues treatment seems to be a rationale alternative in patients suffering from recurrent and residual sporadic RET-negative medullary thyroid cancer when there is evidence of SSTRs presence by their positive immunohistochemical expression in the tissue and/or by the increased uptake in 68Ga-DOTATOC PET/CT."

Clinical • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • Thyroid Gland Papillary Carcinoma • RET • SSTR • SSTR2 • SSTR5

The Role of the GH Receptor Polymorphisms as a Prognostic Factor of Vertebral Fractures in Acromegalic Patients Resistant to First-generation SSAs and Treated with Pegvisomant or Pasireotide LAR. (PubMed, Endocr Metab Immune Disord Drug Targets) - "The GHR polymorphisms could improve the therapeutic approach in acromegaly, tailored to the individual patient, in the context of personalized medicine."

Biomarker • Journal • Acromegaly • Endocrine Disorders • Musculoskeletal Diseases • Orthopedics

Long-term pasireotide-LAR treatment in the personalized therapy of patients with complex acromegaly: a collection of clinical experiences. (PubMed, Drugs Context) - "Pasireotide-LAR allowed the normalization of insulin-like growth factor 1 (IGF1) values in all patients and reduced tumour residue volume where present. A good safety profile and long-term tolerability were also reported."

Journal • Acromegaly • Diabetes • Endocrine Disorders • Metabolic Disorders • Oncology • IGF1

Bone health and skeletal fragility in second- and third-line medical therapies for acromegaly: preliminary results from a pilot single center experience. (PubMed, Pituitary) - "Our preliminary data suggested that in conventional and multi-drug resistant acromegaly, the combination therapy Pasi-Lar + Peg-V may prevent the worsening of BMD and the occurrence of i-VFs. Prospective and translational studies should further validate these results and ascertain underlying physiopathology mechanisms."

Journal • Acromegaly • Endocrine Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • SSTR