Phase 2b study for Betalutin® approval

Offentlig prosjektsammendrag

Nordic Nanovector is a biopharmaceutical company committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. This Skattefunn project covers Nordic Nanovector's 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. 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). 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®. 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 targeted for the first half 2020.