On May 21, 2019 Nordic Nanovector ASA (OSE: NANO) reported that following a safety review of the first patients in the ongoing Archer-1 (LYMRIT 37-07) trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL), the Betalutin dose has been escalated to 15 MBq/kg for the next cohort of patients (Press release, Nordic Nanovector, MAY 21, 2019, https://www.nordicnanovector.com/investors-and-media/press-releases?page=/en/pressreleases/nordic-nanovector%253A-archer-1-phase-1b-betalutin%2528r%2529-rituximab-combination-trial-advances-to-next-cohort-1692267 [SID1234553451]).
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Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation.
Following Betalutin dosing, patients will receive 375 mg/m2 RTX once per week for four weeks. The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. Data read-out is expected during the second half of 2020.
Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the next group of patients in the study, which will enable us to recommend a dose for further evaluation of safety and preliminary efficacy in additional patients."
Rituximab is a CD20-targeting monoclonal antibody that 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 RTX, thus alternative targets and new treatments are important. The combination of anti-CD37 and anti-CD20 modalities could therefore represent a novel dual immunotherapy approach for the treatment of 2L FL patients, and potentially avoid or delay the use of chemotherapy.