The company announces that the first patient has been dosed in the Archer-1 trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL).
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 are important. In addition, developing novel “chemo-free” regimens for patients as an alternative to chemotherapy is desirable.
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 four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.
A possible new way to administer biologic therapy in FL
The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018. These data demonstrate that treatment with the combination of Betalutin and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.
“Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL,” said Eduardo Bravo, Nordic Nanovector CEO.