Oslo, Norway, 6 August 2020. Nordic Nanovector ASA (OSE: NANO) today announces that, following a planned interim analysis of the PARADIGME Phase 2b pivotal trial of Betalutin® in patients with relapsed/refractory follicular lymphoma (FL), the Independent Review Committee (IRC) has recommended Nordic Nanovector to focus on one dosage arm (15 MBq/kg Betalutin® after a pre-dose of 40 mg lilotomab; “40/15”) to completion.

In this very difficult to treat patient population (bulky disease, patients refractory to standard therapies) the interim analysis confirmed activity. Betalutin®, as a single administration, was active (CR, PR and disease control rate) and had a well-tolerated safety and manageable safety profile in both arms. Based on a comprehensive assessment, the interim data set supported the selection of the 40/15 dosage arm which demonstrated consistency across all patient sub-groups. The arm evaluating the regimen of 20 MBq/kg Betalutin® following a pre-dose of 100 mg/m2 lilotomab (“100/20”) will be discontinued.

PARADIGME is the company's ongoing global, randomised Phase 2b trial investigating Betalutin® (¹⁷⁷Lu-lilotomab satetraxetan) as a single administration in patients with 3rd-line relapsed / anti-CD-20-refractory FL who have received two or more prior therapies (3L R/R FL). The trial was designed to enrol 130 patients into two arms to compare different dosing regimens.

Jean Pierre Bizzari, MD, Chair of Nordic Nanovector's Clinical Committee, said: "We are very encouraged by the interim results both the activity and the safety profile in this unmet patient popula…