Nordic Nanovector ASA announced that full results from its Phase 2 clinical trials of Betalutin®? (177Lu lilotomab satetraxetan) in resistant/refractory (R/R) indolent non-Hodgkin's lymphoma (NHL) have been published at EudraCT, the European Union Drug Regulating Authorities Clinical Trials Database (the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union). The data from the Phase 1b/2a LYMRIT 37-01 and the Phase 2b PARADIGME studies can be found via this link: EU Clinical Trials Register: As previously announced on 5 July 2022, the PARADIGME trial of Betalutin®®?

in 3rd-line follicular lymphoma patients refractory to rituximab/anti-CD20 (3L R/R FL) was discontinued following a comprehensive review and independent data evaluation and a subsequent request for regulatory agency interaction. The data from the 109 patients enrolled in PARADIGME up until its discontinuation show: Overall response rate (ORR) was 38.9% and 32.1%; complete response (CR) rate was 20.8% and 14.3% in participants receiving doses of 40/15 (Betalutin®? dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab) and 100/20 (Betalutin®®?

dose of 20 MBq/kg after a pre-dose of 100 mg lilotomab), respectively. Median duration of response (DoR) was approximately 8.5 months for the 40/15 dose and 3.4 months for the 100/20 dose. Median duration of complete response (DoCR) was 8.5 months for 40/15 and 9.2 months for 100/20.

DoR and DoCR are difficult to interpret due to the small number of responders. Over half the participants had progressed 6 months following treatment. The median progression-free survival (PFS) was 5.9 months versus 5.8 months with 40/15 and 100/20, respectively.

The majority of treatment emergent adverse events (TEAEs) were due to cytopenias, most notably decreases in platelets (thrombocytopenia was observed in 19 [16.8%] and platelet count decreased in 11 [9.7%] participants) and neutrophils (neutropenia in 18?[15.9%] and decreased neutrophil count in six [5.3%] participants). Anaemia and fatigue were also reported in >10% of participants.