On June 21, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first patient has been dosed in its pivotal PARADIGME Phase 2b trial with Betalutin (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients who are refractory to anti-CD20 immunotherapy (including rituximab), a population with high unmet medical need (Press release, Nordic Nanovector, JUN 21, 2018, View Source [SID1234527419]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin dosing regimens (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.
The objective of PARADIGME is to determine the best dosing regimen for Betalutin as a new treatment option for 3L FL patients. The data from this study are expected to support market authorisation applications 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. Initial efficacy and safety data read-out for PARADIGME is target for the first half 2020.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "Dosing of the first patient in PARADIGME marks important progress for Nordic Nanovector in the development of Betalutin for the treatment of FL patients. We remain convinced of the drug’s potential in this indication following promising clinical data to-date and look forward to advancing this clinical trial to a successful conclusion."
For further information, please contact:
IR enquiries Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
About Betalutin
Betalutin is a tumour-seeking anti-CD37 antibody (lilotumab) conjugated to a low-intensity radionuclide (lutetium-177). CD37 is highly expressed in B-cell non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target. Betalutin is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells.
Betalutin 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 pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).