The company announces that the final patient has been enrolled in the LYMRIT 37-05 clinical trial of Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation.
“We are delighted to have reached this important milestone and look forward to the preliminary results during the second half of the year. Planning is underway for an expansion cohort to further assess safety and efficacy in this challenging to treat patient population. We expect more patients to be enrolled when the best dose is selected from the first part of the study,” said Lisa Rojkjaer, Chief Medical Officer at Nordic Nanovector.
The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity of a single administration of Betalutin. Patients were enrolled at clinical trial sites in the US and Europe. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).
Preliminary results are expected in the second half of 2019.
DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by Stem Cell Transplantation (ref. 1 below). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024.