Nordic Nanovector announces that the first clinical site in the United States (in Long Beach, CA) for the pivotal PARADIGME trial has been initiated to enable enrolment of patients.
PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin (177Lu-satetraxetan-lilotomab) dosing regimens (15 MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20 MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L follicular lymphoma patients who are refractory to anti-CD20 therapy (including rituximab). The trial aims to enrol 130 patients across 80-85 sites in approximately 20 countries.
“The enrolment of patients into North American sites is important for the overall clinical development program of Betalutin in NHL. We are pleased to have opened the first US site in the PARADIGME trial and anticipate further clinical sites coming on-board in the coming months,” says Lisa Rojkjaer MD, Nordic Nanovector CMO.
The objective of PARADIGME is to determine the best dosing regimen 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. The data from this trial are expected to support market authorisation applications for Betalutin as a new treatment option for 3L FL patients.
The initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.
In June, Betalutin received Fast Track designation in the US for the treatment of patients with 3L R/R FL, and on 24 October, the MHRA granted Betalutin a Promising Innovative Medicine Designation in the treatment of advanced relapsed/refractory follicular lymphoma.