SOMther (lutetium-177 DOTA satoreotide) / Ariceum Therap - LARVOL DELTA

SANTANA-225: A multicentre, open-label, Phase I/II study investigating the safety, tolerability, and preliminary efficacy of 225Ac-SSO110 in participants with extensive stage small cell lung cancer (ES-SCLC) or Merkel cell carcinoma (MCC) receiving Standard of Care (SoC) (EANM 2025) - No abstract available

Clinical • P1/2 data • Lung Cancer • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Improved Tumour Targeting and Efficacy with Comparable Daughter Redistribution of 225 Ac-SSO110 versus 225 Ac-DOTA-TATE in a Preclinical SCLC Model (EANM 2025) - No abstract available

Preclinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

The Role of [177Lu] Lu-Satoreotide Tetraxetan in Somatostatin Receptor-Positive Neuroendocrine Tumors. (PubMed, Semin Nucl Med) - "In this article, we review both preclinical and clinical data evaluating the efficacy and safety of [¹⁷⁷Lu]Lu-satoreotide tetraxetan in the treatment of neuroendocrine tumors. We also provide a brief overview of other SSTR antagonists currently under investigation."

Journal • Review • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC) (ANZCTR) - P1 | N=70 | Active, not recruiting | Sponsor: Ariceum Therapeutics Australia Pty Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

LuSato-1: A theranostic study evaluating the safety and tolerability of 177Lu-satoreotide with 68Ga-PET/CT companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on immune checkpoint inhibitor (ICI) maintenance therapy (SNMMI 2025) - "This study will provide preliminary safety and efficacy of 177Lu-SSO110 in participants with ES-SCLC on ICI maintenance therapy and support the selection of a recommended phase 2 dose."

Checkpoint inhibition • Clinical • Anorexia • Back Pain • Endocrine Cancer • Fatigue • Hepatology • Lung Cancer • Musculoskeletal Pain • Neuroendocrine Tumor • Oncology • Pain • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • SSTR • SSTR2

LuSato-1: A theranostic study evaluating the safety and tolerability of 177Lu-satoreotide with 68Ga-PET/CT companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on immune checkpoint inhibitor (ICI) maintenance therapy (SNMMI 2025) - "This study will provide preliminary safety and efficacy of 177Lu-SSO110 in participants with ES-SCLC on ICI maintenance therapy and support the selection of a recommended phase 2 dose."

Checkpoint inhibition • Clinical • Anorexia • Back Pain • Endocrine Cancer • Fatigue • Hematological Disorders • Hepatology • Lung Cancer • Musculoskeletal Pain • Neuroendocrine Tumor • Oncology • Pain • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • SSTR • SSTR2

Radiolabeled Somatostatin Receptor Antagonist in Patients with metastatic Pheochromocytoma or Paraganglioma; Dosimetry, Efficacy and Safety evaluation (ESPE-ESE 2025) - "This pilot study on mPGGLs** showed that the median tumor absorbed dose per cycle is 1.3 (0.9- 3.5) times higher with 177Lu-DOTA-JR11 compared to 177Lu-DOTA-TOC, resulting in a longer PFS and a good clinical outcome without relevant adverse events after 177Lu-DOTA-JR11 therapy."

Clinical • Metastases • Anemia • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • SSTR

225Ac-SSO110 as next-generation SSTR2 targeting radiopharmaceutical for small cell lung cancer (AACR 2025) - "SSO110 targets a higher number of SSTR2 binding sites and shows longer tumor retention than the SSTR2 agonist DOTATATE translating into higher anti-tumor efficacy of 177Lu-SSO110 compared to 177Lu-DOTATATE. 161Tb-SSO110 demonstrated modestly better efficacy than 177Lu-SSO110, but only in the AR42J model with high and homogenous target expression. Based on promising emerging clinical data from the LuSato1 study with 177Lu-SSO110 and the outstanding preclinical activity of 225Ac-SSO110, a global phase I/II clinical study with 225Ac-SSO110 in patients with ES-SCLC or Merkel Cell Carcinoma on Immune-Checkpoint Inhibitor monotherapy is being initiated."

Lung Cancer • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Pancreatic Cancer • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Ariceum Therapeutics GmbH

New P1/2 trial • Lung Cancer • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

PROMENADE: Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Phase classification: P1 ➔ P1/2 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Phase classification • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Meningioma • Oncology • Solid Tumor • SSTR

Dosimetry, efficacy and safety of radiolabelled somatostatin receptor antagonist in patients with metastatic pheochromocytoma or paraganglioma (ENETS 2025) - "The SSTR antagonist [177Lu]Lu177Lu-DOTA-JR11 (177Lu-JR11) offers potentially increased tumour doses than standard radioligand therapy (RLT) with [177Lu]Lu-DOTA-TOC (177Lu-TOC)...No grade ≥4 events occurred. CONCLUSION The median (range) tumour absorbed dose per cycle is 1.3 (0.9-3.5) times higher with 177Lu-JR11 compared to 177Lu-TOC resulting in normalisation of adrenergic symptoms in 2 of 3 patients."

Clinical • Metastases • CNS Tumor • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Correlation of PET Imaging with the Somatostatin Receptor Antagonist 68Ga-SSO120 with Immunohistochemistry and Survival for Theranostics of SCLC (EANM 2024) - "SSTR2 expression assessed by 68Ga-SSO120 PET and by IHC showed a good correlation and SSTR2 was associated with poorer survival. More than 75% of patients exhibited higher whole-body 68Ga-SSO120 tumour uptake than liver uptake and almost 40% high or very high uptake, indicating the theranostic potential in combination with 177Lu-SSO110 radioligand therapy."

Hepatology • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts (EANM 2024) - "We have previously demonstrated better efficacy of 177Lu-SSO110 over 177Lu-DOTA-TATE in different xenograft models owing to the ability of SSO110 to target a higher number of SSTR2 binding sites and showing longer tumour retention. Our results highlight that 225Ac-SSO110 shows the strongest anti-tumoral effect in vivo even at low, single doses when evaluating SSO110 and DOTA-TATE radiolabelled with different isotopes. The comparison of 161Tb-SSO110 to 177Lu-SSO110 in two models was inconclusive indicating that additional Auger emissions of 161Tb are not generally increasing the anti-tumour efficacy of 161Tb-SSO110 and further model-intrinsic mechanisms could be involved. Irrespective of the isotopes used, the superior pharmacokinetic profile of SSO110 translates into higher pre-clinical anti-tumour efficacy compared to DOTA-TATE."

Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

[225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts (SNMMI 2024) - "Since [177Lu]Lu-SSO110 demonstrated significantly better efficacy than [177Lu]Lu-DOTA-TATE in different xenograft models, the aim of this study was to identify the optimal isotope(s) (225Ac, 212Pb, 161Tb, 177Lu) for SSO110 and how the different SSO110-based radiopharmaceuticals compare to the respective DOTA-TATE compounds. Our data highlights the potential of [225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 to outperform SST2-targeting agonists that are approved or in clinical development. The superior pharmacokinetic profile of SSO110 translates into higher pre-clinical efficacy with several isotopes. The comparison of SSO110 and DOTA-TATE labelled with various isotopes will help guide clinical development of SSO110 across different SST2-expressing indications."

Clinical • Gastrointestinal Cancer • Hepatology • Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

68Ga-SSO120 PET in Patients with Small-Cell Lung Cancer: Correlation with SSTR2 Expression and Survival (SNMMI 2024) - "68Ga-SSO120 PET is a tool for whole-body assessment of SSTR2-expression with SUVmax/SUVpeak correlating to histopathological SSTR2-expression. In patients with SCLC, SSTR2 expression assessed by 68Ga-SSO120 PET andby IHC as well as VALG classification were associated with shorter survival in univariate analyses. Investigation of a larger cohort with longer follow-up is warranted for multivariate analyses including other determinants of survival and to identify candidates for SSTR2-directed radionuclide therapy using 177Lu-SSO110."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

[68Ga]Ga-satoreotide trizoxetan uptake in high grade neuroendocrine lung cancers (SNMMI 2024) - "Our preliminary results show that PET/CT can visualize [68Ga]Ga-satoreotide trizoxetan uptake in LCNEC and SCLC during and after standard therapy. To our knowledge, these are the first published results from [68Ga]Ga-satoreotide trizoxetan-PET/CT in SCLC-patients during and after treatment, and the very first results from [68Ga]Ga-satoreotide trizoxetan PET/CT in patients with LCNEC. The theragnostic couple [68Ga]Ga-satoreotide trizoxetan and [177Lu]Lu-satoreotide tetraxetan, gives hope for a new treatment option for patients with SCLC and LCNEC, and the trial is ongoing."

Endocrine Cancer • Fibrosis • Immunology • Lung Cancer • Neuroendocrine Tumor • Oncology • Respiratory Diseases • Solid Tumor • SSTR • SSTR2

[68Ga]Ga-satoreotide trizoxetan uptake in high grade neuroendocrine lung cancers (SNMMI 2024) - "Our preliminary results show that PET/CT can visualize [68Ga]Ga-satoreotide trizoxetan uptake in LCNEC and SCLC during and after standard therapy. To our knowledge, these are the first published results from [68Ga]Ga-satoreotide trizoxetan-PET/CT in SCLC-patients during and after treatment, and the very first results from [68Ga]Ga-satoreotide trizoxetan PET/CT in patients with LCNEC. The theragnostic couple [68Ga]Ga-satoreotide trizoxetan and [177Lu]Lu-satoreotide tetraxetan, gives hope for a new treatment option for patients with SCLC and LCNEC, and the trial is ongoing."

Endocrine Cancer • Fibrosis • Immunology • Lung Cancer • Neuroendocrine Tumor • Oncology • Respiratory Diseases • Solid Tumor • SSTR • SSTR2

[68Ga]Ga-satoreotide trizoxetan uptake in high grade neuroendocrine lung cancers (SNMMI 2024) - "Our preliminary results show that PET/CT can visualize [68Ga]Ga-satoreotide trizoxetan uptake in LCNEC and SCLC during and after standard therapy. To our knowledge, these are the first published results from [68Ga]Ga-satoreotide trizoxetan-PET/CT in SCLC-patients during and after treatment, and the very first results from [68Ga]Ga-satoreotide trizoxetan PET/CT in patients with LCNEC. The theragnostic couple [68Ga]Ga-satoreotide trizoxetan and [177Lu]Lu-satoreotide tetraxetan, gives hope for a new treatment option for patients with SCLC and LCNEC, and the trial is ongoing."

Endocrine Cancer • Fibrosis • Immunology • Lung Cancer • Neuroendocrine Tumor • Oncology • Respiratory Diseases • Solid Tumor • SSTR • SSTR2

[68Ga]Ga-satoreotide trizoxetan uptake in high grade neuroendocrine lung cancers (SNMMI 2024) - "Our preliminary results show that PET/CT can visualize [68Ga]Ga-satoreotide trizoxetan uptake in LCNEC and SCLC during and after standard therapy. To our knowledge, these are the first published results from [68Ga]Ga-satoreotide trizoxetan-PET/CT in SCLC-patients during and after treatment, and the very first results from [68Ga]Ga-satoreotide trizoxetan PET/CT in patients with LCNEC. The theragnostic couple [68Ga]Ga-satoreotide trizoxetan and [177Lu]Lu-satoreotide tetraxetan, gives hope for a new treatment option for patients with SCLC and LCNEC, and the trial is ongoing."

Endocrine Cancer • Fibrosis • Immunology • Lung Cancer • Neuroendocrine Tumor • Oncology • Respiratory Diseases • Solid Tumor • SSTR • SSTR2

Ariceum Therapeutics to Present Outstanding New Preclinical Data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2024 (PRNewswire) - "Ariceum Therapeutics...today announces that it will be presenting a poster demonstrating the efficacy of its somatostatin receptor 2 (SST2) antagonist, SS0110 (satoreotide)...at this year's Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held 8-11 June 2024 in Toronto, Canada. The poster presentation...compares satoreotide with the SST2 agonist, 225Ac-DOTATATE, and reveals that single doses of 20 MBq 177Lu-satoreotide or 30 kBq 225Ac-satoreotide induce significantly better efficacy than a single dose of 30 kBq 225Ac-DOTATATE. Most remarkably, 30 kBq 225Ac-satoreotide induced complete tumor regression in the NCI-H69 model, something not observed with the same or higher doses of 225Ac-DOTATATE."

Preclinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Dosimetry and pharmacokinetics of [177Lu]Lu-satoreotide tetraxetan in patients with progressive neuroendocrine tumours. (PubMed, Eur J Nucl Med Mol Imaging) - P1/2 | "[177Lu]Lu-satoreotide tetraxetan showed a favourable dosimetry profile, with high and prolonged tumour uptake, supporting its acceptable safety profile and promising efficacy."

Journal • PK/PD data • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Correlation of 68Ga-SSO120 PET with SSTR2 expression and prognostic value in patients with small cell lung cancer (ELCC 2024) - "Conclusions In patients with SCLC, tumor uptake in 68Ga-SSO120 PET correlates with histopathological SSTR2-expression and SSTR2-TV was associated with poorer OS. Investigation of a larger cohort is warranted to analyse other OS determinants (e.g., VALG and type of distant metastases) and to identify candidates for SSTR2-directed radionuclide therapy using 177Lu-SSO110."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

177Lu-satoreotide Tetraxetan Demonstrates Benefit in SSTR2+ NETs (Targeted Oncology) - "'Almost no NET case is alike. It can arise in many different organs, and the spectrum of aggressiveness is from the slowest growing solid tumors to the fastest growing. Also, the treatment can be complex depending on whether it's liver dominant or not, the differentiation grade, stage, and somatostatin receptor expression, Jonathan Strosberg, MD, previously told Targeted Oncology, in an interview."

Interview

A phase I/II study of the safety and efficacy of [Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. (PubMed, Eur J Nucl Med Mol Imaging) - P1/2 | "[Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing."

Journal • Metastases • P1/2 data • P2 data • Endocrine Cancer • Hematological Disorders • Hematological Malignancies • Neuroendocrine Tumor • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • SSTR

Ariceum Therapeutics’ targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours (PRNewswire) - P1/2 | N=40 | NCT02592707 | Sponsor: Ipsen | "Ariceum Therapeutics...is pleased to announce the publication of positive results from a Phase I/II trial of its radiopharmaceutical 177Lu-satoreotide tetraxetan (satoreotide) in patients with previously treated, progressive neuroendocrine tumours...The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and typical lung NETs, paraganglioma, and pheochromocytoma...Of the 38 patients for whom full results were obtained, 28 (73.7%) achieved stable disease, as determined eight weeks after the last infusion. A further 8 (21.1%) experienced a partial response (a reduction in tumour size) – giving a total Disease Control Rate (DCR) of 94.7%. 17 of the 40 patients (42.5%) experienced grade ≥3 treatment–related adverse events, the most common being lymphopenia, thrombocytopenia, and neutropenia. Two patients developed myeloid neoplasms considered treatment-related by the..."

P1/2 data • Trial status • Neuroendocrine Tumor