The Phase 2b trial with Betalutin (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients has been approved by the Regional Committees for Medical and Health Research Ethics (REK) in Norway.
Nordic Nanovector has now received all necessary approvals to begin PARADIGME in Norway and will commence start-up activities with the selected clinical sites immediately with the intention of recruiting patients into the study as soon as possible.
Phase 2b trial
PARADIGME is a global, randomised Phase 2b clinical trial comparing two Betalutin dosing regimens in patients with third-line follicular lymphoma who are refractory to anti-CD20 immunotherapy (including rituximab), a population with a high unmet medical need. The trial will enroll 130 patients at 80-85 sites in approximately 20 countries. The first patient is expected to be dosed in the first half of 2018 and the data read-out is targeted to the first half of 2020.