Nordic Nanovector has opened its first clinical site in the US at Long Beach in California for the PARADIGME trial to evaluate its tumor-seeking anti-CD37 antibody Betalutin (lilotomab) in third-line (3L) follicular lymphoma.
With the opening of the US clinical trial site, the Norwegian biopharma company has initiated the global randomized phase 2b trial of its investigational lymphoma drug Betalutin, by commencing enrolment of patients.
Nordic Nanovector will be 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) in the PARADIGME trial.
The phase 2b trial will be looking to take in 130 patients in 80-85 sites in nearly 20 countries.
Nordic Nanovector CMO Lisa Rojkjaer, commenting on the PARADIGME trial of its lymphoma drug Betalutin, said: “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.”
The goal of the PARADIGME clinical trial is to establish the best dosing regimen for Betalutin as a new option for the treatment of 3L follicular lymphoma patients.
The primary endpoint for the phase 2b trial is overall response rate (ORR) while secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life.
The data from the PARADIGME clinical trial are anticipated to support market authorization applications for Betalutin as a new treatment option for 3L follicular lymphoma patients.
Nordic Nanovector expects the initial efficacy and safety data of the PARADIGME clinical trial to come out during the first half of 2020.
In June, the investigational lymphoma drug Betalutin secured fast track designation in the US for the treatment of patients with 3L R/R follicular lymphoma. Very recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted it a promising innovative medicine designation for advanced relapsed/refractory follicular lymphoma treatment.