On October 26, 2018 Nordic Nanovector ASA (OSE: NANO) reported 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 (Press release, Nordic Nanovector, OCT 26, 2018, View Source [SID1234553491]).
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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.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "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 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.
About Betalutin
Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20 immunotherapy (including rituximab).
Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with rituximab in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).
Betalutin has been granted Fast Track designation (in June 2018) in the US for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014.
Betalutin is selective for CD37, a novel therapeutic target protein that is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.