On May 25, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that initial promising data from the Archer-1 Phase 1b trial investigating Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, MAY 25, 2021, View Source [SID1234580585]).

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The preliminary results show clinical activity with seven out of seven patients achieving a response, including 5 complete responses and 2 partial responses. All responses are currently ongoing, 5 of them 2 years after Betalutin administration.

Across this patient group, Betalutin with RTX showed a very good safety profile, comparable to that of single agent Betalutin, with no dose limiting toxicities observed.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of CD37-targeted Betalutin in combination with CD20-targeted RTX in patients with relapsed/refractory FL who have received one or more prior therapies.

The starting doses of Betalutin and lilotomab were 10MBq/kg and 40mg, respectively, which was escalated to Betalutin 15MBq/kg and lilotomab 40mg in the second cohort. Following Betalutin dosing, patients received four weekly doses of RTX (375mg/m2) on days 7, 14, 21 and 28. Patients who did not progress (including CR, PR, SD) were scheduled to receive RTX maintenance for 2 years.

The primary objective of the study was to evaluate the safety and tolerability of Betalutin in combination with RTX, the secondary objective to evaluate the preliminary anti-tumour activity of combination treatment.

The rationale for Archer-1 was provided by earlier preclinical data showing Betalutin can up-regulate CD20 expression in different rituximab-sensitive NHL cell lines and act synergistically with rituximab in a rituximab-sensitive NHL animal model and, more recently, that Betalutin has the potential to counteract resistance to rituximab in non-Hodgkin’s lymphoma models.

Peter Braun, Nordic Nanovector CEO, commented: "We are encouraged by the results in this small Phase I study in second line FL patients. Both the overall safety of this combination and the preliminary signs of efficacy are promising. We look at this study as an additional building block in our overall strategy to develop Betalutin for difficult to treat hematological tumors. Our near-term focus remains very much on completing PARADIGME in 3L FL and delivering top line 3-month data by the end of 2021.