Oslo, Norway, 1 December 2020<br />
<br />
Nordic Nanovector ASA (OSE: NANO) announces that it has completed enrolment
into<br />
the LYMRIT 37-05 Phase 1 clinical trial of Betalutin[®] ([177]Lu lilotomab<br />
satetraxetan) in patients with relapsed/refractory diffuse large B-cell
lymphoma<br />
(R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT).<br />
<br />
Eighteen DLBCL patients were enrolled into the trial at clinical trial sites
in<br />
the US and Europe and were dosed with three escalating treatment doses of<br />
Betalutin[®] (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is<br
/>
expected in H1'2021.<br />
<br />
As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of<br
/>
these data, which is expected to inform plans for the further development of<br
/>
Betalutin[®] in R/R DLBCL.<br />
<br />
Nordic Nanovector's primary focus is the timely completion of the pivotal
Phase<br />
2b PARADIGME trial of Betalutin[®] in 3rd-line follicular lymphoma (3L FL).<br
/>
<br />
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said:<br
/>
"The completion of recruitment into this dose-finding study in patients with<br
/>
DLBCL is an important milestone. DLBCL remains a significant indication with
a<br />
large unmet medical need. The data analysis from this trial will form the
basis<br />
of our considerations for the further development of Betalutin[®] in DLBCL
and<br />
more broadly across non-Hodgkin's lymphoma."<br />
<br />
The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation<br
/>
study in DLBCL designed to determine the dose to be recommended for further<br
/>
studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile<br
/>
and preliminary anti-tumour activity of a single administration of
Betalutin[®].<br />
More information on this study can be found at www.clinicaltrials.gov<br />
(NCT02658968).<br />
<br />
DLBCL is an aggressive form of non-Hodgkin's Lymphoma (NHL) that accounts for<br
/>
30% of all NHL cases[1,2]. The number of diagnosed incident cases of DLBCL in<br
/>
the seven major markets (US, key five European markets and Japan) was 64,172
in<br />
2018 and is expected to grow to 74,927 in 2028[3].<br />
<br />
Approximately 40% of DLBCL patients relapse after first-line combination<br />
treatment with rituximab and chemotherapy. These patients have few
therapeutic<br />
options, with high-dose chemotherapy and autologous stem cell transplant
(ASCT)<br />
achieving long-term remissions in only a minority of patients[4]. Relapsed
DLBCL<br />
therefore remains a serious unmet medical need.<br />
<br />
References<br />
<br />
 1. Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J.
Clin.<br />
2019