On November 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it enrolled the final two patients into the second safety cohort of its Phase 1 Archer-1 (LYMRIT 37-07) trial investigating safety and preliminary efficacy of Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab in 2nd-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 19, 2020, View Source [SID1234571374]).
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The dosing regimen in this cohort is a single administration of 15 MBq/kg Betalutin preceded by 40mg lilotomab, followed by 375 mg/m2 rituximab once per week for four weeks.
Data from this cohort is expected in H1’2021 and will be analysed alongside the data generated from the first cohort of patients receiving 10 MBq/kg Betalutin/40mg lilotomab.
As announced in April 2020, Archer-1 is expected to be paused pending this analysis, which is expected to inform plans for the further development of Betalutin development in 2L FL. The Company’s primary focus for its resources is on the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line FL (3L FL).
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "We are pleased to complete patient enrolment into the second safety cohort of Archer-1. We look forward to the results from this cohort in H1’2021, which will add to our understanding of Betalutin use in FL patients. The data will also inform our thinking towards further development strategies for Betalutin in broader FL populations than that being investigated in our PARADIGME trial in 3L FL."
About Archer-1
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial designed to assess the safety and preliminary activity of combining the CD37-targeted radioimmunoconjugate Betalutin with the CD20-targeted immunotherapy rituximab in patients with relapsed/refractory (2L) FL who have received one or more prior therapies.
Rituximab was approved for the treatment of non-Hodgkin’s lymphoma (NHL), including FL, more than 20 years ago and is the current standard of care. It is administered to patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to rituximab, thus alternative targets and new treatments are important.