"NANO: Betalutin® shows strong clinical profile"

11.12.2017 kl 07:11

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Betalutin® shows strong clinical profile in relapsed/refractory indolent NHL and follicular lymphoma

Updated data reported at the 59th Annual American Society of Hematology (ASH) meeting
The updated data continue to highlight Betalutin®’s strong 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.

Dr Arne Kolstad, MD, Principal Investigator of the study, commented: “The data presented at ASH are very exciting. The combination of efficacy, tolerability and the convenience of a single administration highlight Betalutin®’s potential in this primarily elderly, heavily pre-treated patient population. Notably, the CRs seen in both Arm 1 and Arm 4 in FL patients and the duration of responses are very promising, and we look forward to treating more patients in the upcoming PARADIGME study.

Dr Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, added: “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.”