Independent Review Committee Recommends Nordic Nanovector to focus on one dosage arm for the Pivotal PARADIGME Phase 2b Trial in Patients with 3L R/R FL
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 population. We believe that the decision to focus on one arm as well as the ongoing implementation of the protocol amendments will significantly support an increase of the enrolment rate to PARADIGME.”
Lars Nieba, interim Chief Executive Officer, commented: “The recommendation from the IRC to advance the 40/15 arm of PARADIGME provides a clear path for Betalutin® late-stage clinical development in patients with FL, especially those who are elderly and fragile and have no or limited treatment options. We will continue to focus on implementing the protocol amendments and other initiatives that will broaden the patient inclusion criteria’s and improve the enrolment rate. We will complete recruitment for the PARADIGME trial as quickly as possible despite the evolving COVID-19 situation. With the timely adoption of our protocol amendments and enrolment initiatives, we are confident that we can announce the three-month top-line data from PARADIGME in 2H 2021, paving the way for a planned regulatory filing with Betalutin®.”
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