Nordic Nanovector kicks off phase 1 Betalutin studyMarch 17, 2017
Nordic Nanovector ASA has begin dosing patients in its Phase 1 Betalutin study, testing a CD37 targeting antibody-radionuclide conjugate, in patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are ineligible for stem cell transplantation.
Dr. Lisa Rojkjaer, Nordic Nanovector’s Chief Medical Officer, said that the encouraging data seen in the Phase 1/2 study in relapsed indolent NHL provide a strong foundation to advance development of Betalutin into this second indication.
“This is an area of significant medical need with no approved treatment options,” said Rojkjaer.
DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. According to Nordic Nanovector, after first line combination treatment with rituximab-chemotherapy (R-CHOP) approximately 40% of DLBCL patients relapse and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by stem cell transplant (SCT). There are currently very few therapeutic options for patients not eligible for SCT, which make this disease a serious unmet medical need, with a population of over 14 000 patients in the US, EU-5 and Japan. The market for treatment of DLBCL is estimated to be worth more than $4.5 billion by 2024, says the company, referring to Non-Hodgkin’s Lymphoma (2015) Decision Resources.
The open-label, single-arm, dose-escalation study is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin. Up to 24 patients are planned to be enrolled in the US and EU.