Nordic Nanovector has presented updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory (R/R) indolent NHL (iNHL) at the 59th Annual ASH meeting (9-12 December 2017 in Atlanta, GA, USA).
The updated data continue to highlight Betalutin’s clinical profile as a single agent for treatment of R/R iNHL, and particularly of third-line R/R follicular lymphoma (3L FL), the primary patient population for which Betalutin is initially being developed.
Single-agent Betalutin is effective and well-tolerated in patients with R/R iNHL:
· 90% of all patients (n=59) had a reduction in tumour size
· Overall response rate (ORR) of 60% and complete response (CR) of 24% for all evaluable iNHL patients
· Highly active in patients with 2 or more prior therapies (3L FL) with 66% ORR and 25% CR
· Encouraging results in FL patients:
o Arm 1 40/15: 68% ORR and 28% CR
o Arm 4 100/20: 50% ORR and 25% CR
· Durable responses, especially for patients with a CR
o 13.3 months for all iNHL patients
▪ 20.5 months for patients with CR
o 13.3 months for FL patients treated with 40 mg lilotomab/15 MBq/kg Betalutin®
▪ 22.9 months for patients with CR
As reported previously, Betalutin treatment was well-tolerated with a safety profile characterized by reversible transient neutropenia and thrombocytopenia and a low incidence of infections.
“We are very pleased about these data, which continue to demonstrate a strong clinical profile for Betalutin®, particularly in 3L FL patients. The CR rates are especially encouraging. This is a population of high unmet medical need for whom safe effective therapies are needed, and the Phase 2b PARADIGME trial will focus on these patients. The results obtained provide a strong foundation for this trial,” said Dr Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector.