Nordic Nanovector begins Phase 1b trial of Betalutin and Rituximab combo for follicular lymphoma

Nordic Nanovector has commenced the dosing of the first patient in its Phase 1b clinical trial, dubbed Archer-1, which aims to evaluate the combination of its investigational lymphoma drug Betalutin (177Lu-satetraxetan-lilotomab) with Roche’s rituximab (RTX) as a second-line treatment for follicular lymphoma (2L FL). This trial is a critical step in exploring novel treatments for patients who have not responded to conventional therapies.

Archer-1 Trial Overview

Archer-1 is an open-label, single-arm, multi-centre dose-escalation trial designed to assess the safety and preliminary efficacy of the Betalutin-rituximab combination. The trial will include 20-25 patients with relapsed or refractory follicular lymphoma who have undergone one or more previous treatments. The starting dose of Betalutin will be 10 MBq/kg, while lilotomab will start at 40 mg, with options to escalate the dosage. Patients will also receive four weekly doses of rituximab at 375 mg/m².

The trial’s primary endpoint is to evaluate the safety of the combination therapy, with secondary endpoints including overall response rate, duration of response, progression-free survival, and overall survival.

The Need for Novel Treatments

Nordic Nanovector emphasizes the need for new treatment strategies due to the potential development of resistance to rituximab over time. The company notes that alternative targets and “chemo-free” regimens are crucial for improving patient outcomes. The Archer-1 trial is driven by preclinical data indicating that the Betalutin-rituximab combination significantly prolongs overall survival in a murine model of non-Hodgkin lymphoma (NHL) compared to either treatment alone. This effect is thought to be due to the reversal of CD20 downregulation and resistance mechanisms.

Eduardo Bravo, CEO of Nordic Nanovector, remarked, “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.”

Expansion of Clinical Efforts

In addition to Archer-1, Nordic Nanovector has recently launched its first clinical site in the United States at Long Beach, California, for the PARADIGME clinical trial. This study will assess the tumor-seeking anti-CD37 antibody Betalutin (lilotomab) in third-line follicular lymphoma, further expanding the company’s research into innovative lymphoma treatments.