Launched in November 2018 in Nantes, France, the phase 1-2 study evaluating the safety, tolerability and efficacy of 177lu-OPS201 in patients with somatostatin receptor-positive neuroendocrine tumors is nearing completion. The last injection to a patient took place on July 28, 2020.

Forty patients with somatostatin receptor-positive neuroendocrine tumours participated in this non-randomized, multicentre phase 1-2 trial initiated by Ipsen. Objective: to determine the efficacy/safety ratio of 177lu-OPS201, a new radiotherapy compound capable of binding to specific somatostatin receptors present on the surface of neuroendocrine tumours, at different dosages and doses. In Nantes, the radiopharmacists of the APUI (Annex to the Internal Use Pharmacy of the Nantes University Hospital) were on hand. On the Arronax premises, they prepared and quality controlled the 29 doses intended for the 11 patients from the nuclear medicine department of Nantes University Hospital and the ICO included in the study.

Mickaël Bourgeois and Aurélien Vidal, radiopharmacist and engineer at the APUI, set up and piloted the study on the Nantes site for more than three years. Another clinical trial launched by Ipsen and drawing on APUI’s expertise to evaluate 177Lu-3BP-227 therapy in patients with solid tumours expressing the neurotensin 1 receptor is still ongoing. “Through these trials, the first we conducted with Ipsen, we have demonstrated our ability to make sterile injectable radiopharmaceuticals according to good preparation practices in line with industrial prerequisites,” commented Mickaël Bourgeois.

Contact : Mickaël Bourgeois (APUI)