Targeted therapies company Nordic Nanovector ASA (OSE:NANO) revealed on Thursday the start of treatment of the first patient in its pivotal PARADIGME Phase 2b trial with Betalutin in third-line (3L) follicular lymphoma (FL) patients who are refractory to anti-CD20 immunotherapy (including rituximab).
The company said PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin (177Lu-satetraxetan-lilotomab) dosing regimens (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients.
In conjunction with the PARADIGME study, the company aims to enrol 130 patients across 80-85 sites in about 20 countries.
The objective of PARADIGME is to determine the best dosing regimen for Betalutin as a new treatment option for 3L FL patients. The data from this study are expected to support market authorisation applications for Betalutin as a new treatment option for 3L FL patients. The primary endpoint for the trial is overall response rate (ORR) and the initial efficacy and safety data read-out for PARADIGME is target for the first half 2020.
According to the company, Betalutin is a tumour-seeking anti-CD37 antibody (lilotumab) conjugated to a low-intensity radionuclide. CD37 is highly expressed in B-cell non-Hodgkin's lymphoma, representing a novel therapeutic target. Betalutin is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells.
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