Betalutin® is being developed as potential new treatment for B cell lymphomas. Initially Nordic Nanovector is targeting relapsed Follicular Lymphoma (FL) and relapsed Diffuse Large B Cell Lymphoma (DLBCL), two of the most prevalent forms of NHL.
Betalutin® is undergoing a Phase 1/2 (Lymrit 37-01) clinical trial for treatment of relapsed FL. Preliminary clinical data from the study, presented at the American Association of Cancer Research annual conference (April 2016) showed that:
- Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible
- Betalutin® delivers a highly favourable response rate (best response) in this heavily pre-treated patient population (Overall Response Rate 63.2% and Complete Response 31.6%)
- The median Duration of Response (DoR) has not yet been reached. Clinical responses observed are sustained, with DoR exceeding 12 months in most responders
The study will also investigate further doses of Betalutin® and pre-dosing regimens designed to select an optimal regimen to take into a pivotal Phase 2 trial in relapsed Follicular Lymphoma (PARADIGME: Phase 2 Antibody-RADIonuclide conjugate treatment of non-HodGkin LymphoMa PatiEnts).
Nordic Nanovector’s clinical development strategy is aimed at a first regulatory submission in 1H 2019, and in parallel to run studies in 2nd line FL and DLBCL.