Nordic Nanovector has announced the dosing of the first patient in a phase 1b clinical trial called Archer-1 for evaluating the combination of its investigational lymphoma drug Betalutin (177Lu-satetraxetan-lilotomab) with Roche cancer drug rituximab (RTX) as a second-line treatment for follicular lymphoma (2L FL).
Rituximab is a CD20-targeting monoclonal antibody that is given as a single agent or in combination with chemotherapy to newly-diagnosed or relapsed follicular lymphoma patients.
According to Nordic Nanovector, over time, patients could develop resistance to rituximab, which is why alternative targets are crucial. Apart from that, developing novel “chemo-free” regimens for patients as an alternative to chemotherapy is desirable, said the Norway-based pharma company.
Archer-1 is an open-label, single-arm, multi-centre dose-escalation trial. It will study the safety and preliminary activity of the Betalutin rituximab combination in 20-25 patients having relapsed/refractory follicular lymphoma who had been subjected to one or more prior therapies.
While the starting dose of Betalutin is going to be 10MBq/kg, the starting dose of lilotomab will be 40mg, with an option for escalating the dose.
After dosing with Betalutin, patients will be subjected to four weekly doses of rituximab (375mg/m2).
The primary endpoint of the Archer-1 clinical trial is safety while secondary endpoints include overall response rate, duration of response, progression free survival along with overall survival.
Nordic Nanovector said that the need for the Archer-1 clinical trial has driven by preclinical data which showed Betalutin rituximab combination therapy to have prolonged overall survival in a murine model of NHL to a significant extent compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to the Roche cancer drug.
Eduardo Bravo – Nordic Nanovector CEO, commenting on the phase 1b clinical trial of the Betalutin rituximab combination for the treatment of follicular lymphoma, said:
“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.”
Last month, Nordic Nanovector opened its first clinical site in the US at Long Beach in California for the PARADIGME clinical trial to assess the tumor-seeking anti-CD37 antibody Betalutin (lilotomab) in third-line (3L) follicular lymphoma.