On December 1, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it has completed enrolment into the LYMRIT 37-05 Phase 1 clinical trial of Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT) (Press release, Nordic Nanovector, DEC 1, 2020, View Source [SID1234571999]).

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!

Eighteen DLBCL patients were enrolled into the trial at clinical trial sites in the US and Europe and were dosed with three escalating treatment doses of Betalutin (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is expected in H1’2021.

As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of these data, which is expected to inform plans for the further development of Betalutin in R/R DLBCL.

Nordic Nanovector’s primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "The completion of recruitment into this dose-finding study in patients with DLBCL is an important milestone. DLBCL remains a significant indication with a large unmet medical need. The data analysis from this trial will form the basis of our considerations for the further development of Betalutin in DLBCL and more broadly across non-Hodgkin’s lymphoma."

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study in DLBCL designed to determine the dose to be recommended for further studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for 30% of all NHL cases1,2. The number of diagnosed incident cases of DLBCL in the seven major markets (US, key five European markets and Japan) was 64,172 in 2018 and is expected to grow to 74,927 in 20283.

Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy. These patients have few therapeutic options, with high-dose chemotherapy and autologous stem cell transplant (ASCT) achieving long-term remissions in only a minority of patients4. Relapsed DLBCL therefore remains a serious unmet medical need.

References

Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019;69(1):7-34
View Source
Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), 2020, Decision Resources Group, Clarivate
Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019 May;94(5):604-616.