On December 12, 2019 Nordic Nanovector ASA (OSE: NANO) reported an update on its LYMRIT 37-05 Phase 1 trial of Betalutin in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not eligible for autologous stem cell transplantation (SCT) (Press release, Nordic Nanovector, DEC 12, 2019, View Source [SID1234552337]). DLBCL is an aggressive form of non-Hodgkin’s lymphoma (NHL) and accounts for up to 43% of all cases, making it the most common type of NHL.
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!
This open-label, dose-escalation safety trial is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin in up to 24 patients. The primary goal of the trial is to identify the maximally tolerated dose of Betalutin which will then be further evaluated for safety and anti-tumour activity in an expansion cohort in order to select the recommended dose for phase 2. Three additional patients are currently being enrolled for further evaluation of the final dose cohort as one patient has experienced a reversible DLT (dose limiting toxicity).
On the three completed cohorts, no safety issues were identified. Evidence of disease control has been noted in some of the enrolled patients. We expect to complete the data read-out for the dose-escalation phase and submit the data to an international congress in 1H 2020.
Eduardo Bravo, Nordic Nanovector’s Chief Executive Officer, commented: "Patients with relapsed/refractory DLBCL who are not eligible for stem cell transplantation have very limited treatment options and a poor prognosis. As the safety profile of Betalutin will guide its potential for combination regimens as well as single agent consolidation therapy, we look forward to completing this part of the trial and proceeding with the expansion cohort."