Nordic Nanovector ASA (OSE: NANO) announces that the first patient has been dosed in its pivotal PARADIGME Phase 2b trial with Betalutin® (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients who are refractory to anti-CD20 immunotherapy (including rituximab), a population with high unmet medical need.
PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin® dosing regimens (15MBq/kg Betalutin® following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin® following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 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 secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. Initial efficacy and safety data read-out for PARADIGME is target for the first half 2020.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “Dosing of the first patient in PARADIGME marks important progress for Nordic Nanovector in the development of Betalutin® for the treatment of FL patients. We remain convinced of the drug’s potential in this indication following promising clinical data to-date and look forward to advancing this clinical trial to a successful conclusion.”