Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, 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 (NETs), in the European Journal of Nuclear Medicine and Molecular Imaging.
Satoreotide combines Ariceum’s proprietary peptide satoreotide – a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SSTR2) – with the radioactive isotope ‘payload’ 177Lutetium. SSTR2 is a cell surface protein often overexpressed in certain cancers, including NETs and small cell lung cancer (SCLC).
The Phase I/II trial was initiated by Ipsen, and recently completed after Ariceum acquired satoreotide from Ipsen. This international study was conducted in 7 countries – Australia, Austria, Canada, Denmark, France, Switzerland, and the UK – and enrolled 40 patients with advanced, SSTR2-positive NETs. The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma. All patients had undergone several lines of treatment, including chemo- and/or radiotherapy (45%), before they were treated with 177Lu-satoreotide. Most patients received three infusions of satoreotide, with the median cumulative radiation dose being 13.0 GBq.
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 investigator.
The authors of the study, titled “A phase I/II study of the safety and efficacy of [ 177Lu]Lu‑satoreotide tetraxetan in advanced somatostatin receptor‑positive neuroendocrine tumours”, concluded satoreotide “has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs”. They also discussed that the lower administered activity, 3 cycles of 4.5 GBq compared to 4 cycles of 7.4 GBq with 177Lu-DOTATATE, may offer advantages regarding the treatment burden for patients, but also in terms of reduction of nuclear waste and direct radioisotope costs. A 5-year follow-up study is ongoing.
Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: “These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours. Not only did a high proportion of treated patients achieve stable disease or better, but they did so on a lower dose of radiation than the investigators initially thought was needed. These results will greatly assist Ariceum in further developing satoreotide for hard-to-treat neuroendocrine cancers such as small cell lung cancer.”
Further details on the study can be found on Clinical Trials, under identifier NCT05017662.
Wild, D., Grønbæk, H., Navalkissoor, S. et al. A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. Eur J Nucl Med Mol Imaging (2023). https://doi.org/10.1007/s00259-023-06383-1