Nordic Nanovector Announces First Patient Dosed in Pivotal PARADIGME Trial of Betalutin® in Third-line Follicular Lymphoma Patients
Oslo, Norway, 21 June 2018
Nordic Nanovector ASA (OSE: NANO) announces 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.
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:
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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).
About Nordic Nanovector
Nordic Nanovector is 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.
Further information about the Company can be found at www.nordicnanovector.com
Source: Nordic Nanovector