Nordic Nanovector launches US Phase 2b trial for Betalutin in follicular lymphoma

Nordic Nanovector, a Norwegian biopharmaceutical company, has commenced the first clinical site in the United States for its PARADIGME trial. This pivotal trial is designed to assess the efficacy of Betalutin (lilotomab), an innovative anti-CD37 antibody, in treating third-line (3L) follicular lymphoma patients who have previously failed anti-CD20 therapies.

PARADIGME Trial Marks a Significant Milestone

The PARADIGME trial, a global randomized Phase 2b study, will evaluate two dosing regimens of Betalutin: 15 MBq/kg with a pre-dose of 40 mg lilotomab, and 20 MBq/kg with a pre-dose of 100 mg/m² lilotomab. The trial aims to enroll 130 patients across 80-85 sites in nearly 20 countries. This marks a crucial step in the drug’s clinical development, following its recent fast-track designation by the US Food and Drug Administration and promising innovative medicine status from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Key Objectives and Endpoints

The primary endpoint of the PARADIGME trial is overall response rate (ORR), with secondary endpoints focusing on duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety, and quality of life. The trial’s goal is to determine the optimal dosing regimen for Betalutin, offering a new therapeutic option for patients with 3L follicular lymphoma.

Lisa Rojkjaer, Chief Medical Officer at Nordic Nanovector, emphasized the importance of North American sites for the trial, stating, “The enrolment of patients into North American sites is important for the overall clinical development program of Betalutin in NHL. We are pleased to have opened the first US site in the PARADIGME trial and anticipate further clinical sites coming on-board in the coming months.”

Future Prospects and Expectations

Nordic Nanovector anticipates that the initial efficacy and safety data from the PARADIGME trial will be available in the first half of 2020. This data is expected to support market authorization applications, potentially positioning Betalutin as a new treatment for 3L follicular lymphoma patients.

The company’s strategic move into the US market underscores the growing momentum behind Betalutin and its potential to meet an urgent medical need in treating advanced forms of follicular lymphoma.