Nordic Nanovector Announces Initial Results from LYMRIT 37-05 Phase 1 Trial of Betalutin® in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Nordic Nanovector Announces Initial Results from LYMRIT 37-05 Phase 1 Trial of Betalutin® in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Oslo, Norway, 22 June 2021

Nordic Nanovector ASA (OSE: NANOV) announces encouraging initial results from the LYMRIT 37-05 Phase 1 trial investigating Betalutin® (¹⁷⁷Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for stem cell transplantation.

The initial results from the completed Phase I study (n=16 treated with Betalutin®) show that Betalutin® was well tolerated, with a good safety profile consistent with all previous studies with Betalutin®. As reported previously, a single, reversible dose-limiting toxicity (DLT) was seen in the last cohort investigating the highest dosing regimen (20 MBq/kg Betalutin® and 100 mg/m² lilotomab), which on review by the Independent Review Committee (IRC) resulted in three additional patients being enrolled. No further DLTs were seen. Clinical activity of Betalutin® was seen in 6 evaluable patients receiving the highest dosing regimen including one complete response and one partial response.The IRC commented that the safety and anti-tumour activity of the highest dosing regimen could be considered for investigation in combination with other therapies used in R/R DLBCL which the Company is now evaluating, with an emphasis on combination partners that would not compromise the current safety profile of Betalutin®.

Peter Braun, Nordic Nanovector CEO, commented: “We continue to be very encouraged by the overall safety profile that Betalutin® exhibits in even the most fragile and highly pre-treated NHL patients. We have also seen clinical activity in DLBCL patients from a single administration of Betalutin® and we will now consider the next steps for its development in this large patient population potentially in combination with other therapies, as part of our overall strategy to develop Betalutin® for difficult to treat haematological tumours. Our near-term focus remains very much on completing PARADIGME in 3^rd-line follicular lymphoma and delivering top line 3-month data by the end of 2021.”

About LYMRIT 37-05

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety and preliminary anti-tumour activity of a single administration of Betalutin®. Patients were enrolled at clinical trial sites in the US and Europe. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

The starting doses of Betalutin® and lilotomab were 10MBq/kg and 60mg (Cohort 1, n=3), respectively, and then Betalutin® 10MBq/kg and lilotomab 100mg (Cohort 2, n=3 treated with Betalutin®). Cohort 3 received 15MBq/kg and lilotomab 100mg (n=3) and Cohort 4 received 20MBq/kg and lilotomab 100mg (n=7 treated, 6 evaluable). 

About DLBCL

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. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by Stem Cell Transplantation (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed incident cases of DLBCL in the 7 major markets (U.S., and key 5 European markets and Japan) was 64,172 in 2018 and is expected to be 74,927 in 2028 (ref. 2).  The value of the 3L DLBCL market segment in the key 7 pharma markets is expected to increase from USD 0.6B in 2019 to USD 1.3B in 2028, the value of the 2L DLBCL market segment is expected to increase from USD 0.4B in 2019 to USD 2.0B in 2028. (ref. 2).

1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70

2. NHL and CLL Report, CRG, 2000, Disease Landscape and Forecast

For further information, please contact:

IR enquiries

Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com