On June 10, 2022 Nordic Nanovector ASA (OSE: NANOV) reported an update 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 (Press release, Nordic Nanovector, JUN 10, 2022, View Source [SID1234615896]).
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The latest data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Vienna, Austria on 10 June 2022 shows that Betalutin continues to be well tolerated with no further dose-limiting toxicity (DLT). The data analysis showed that clinical activity of Betalutin was seen with two complete responses out of 16 evaluable patients.
Erik Skullerud, Nordic Nanovector CEO, commented: "This update from the LYMRIT 37-05 trial being presented at EHA (Free EHA Whitepaper) shows two complete responses, demonstrating early signs of efficacy for Betalutin in this fragile and heavily pre-treated patient population. Importantly this is combined with a consistently good safety profile. There remains a need for combination therapies that provide high response rates with a curative intent and a low side effect burden for R/R DLBCL patients, and we continue to explore the options for advancing Betalutin in this setting with the right therapeutic combination partner."
Details of the poster presentation on 10 June at EHA (Free EHA Whitepaper) are as follows:
Title: BETALUTIN IN PATIENTS WITH RELAPSED/ REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) NOT ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANT
Authors: Illidge T, Beasley M, Gomez Codina J, Vavallo F, Pascal V, Wills V
Session Title: Poster session
Session date and time: Friday, June 10 202 – 16:30 – 17:45 CEST
Final Abstract Code: P1165
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 10 MBq/kg and 60 mg (Cohort 1, n=3), respectively, and then Betalutin 10 MBq/kg and lilotomab 100 mg (Cohort 2, n=3 treated with Betalutin). Cohort 3 received 15 MBq/kg and lilotomab 100 mg (n=3) and Cohort 4 received 20 MBq/kg and lilotomab 100 mg (n=7).
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