On December 4, 2016 Nordic Nanovector ASA (OSE: NANO) reported the updated results from its ongoing Lymrit 37-01 Phase 1/2 clinical trial of Betalutin (177Lu-satetraxetan-lilotomab) in subjects with relapsed non-Hodgkin lymphoma (NHL) at the 58th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (San Diego, CA, USA) (Press release, Nordic Nanovector, DEC 4, 2016, View Source [SID1234516900]).
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The updated data confirm Betalutin’s promising efficacy and favourable safety profile as a single agent in 38 relapsed NHL patients, having failed multiple prior regimens and being eligible for assessments. The results, based on the data cut-off date of 31 October 2016, were presented by the study’s Principal Investigator Dr. Arne Kolstad from the Department of Oncology at the Oslo University Hospital, Radiumhospitalet.
Key conclusions:
• In the 35 patients evaluable for efficacy, the Overall Response Rate (ORR) was 63%, with 29% Complete Responses (CR)
• The 21 evaluable patients in the study who received Betalutin at the dose of 15 MBq/kg with 40 mg/m2 lilotomab pre-dosing had an ORR of 62% and a CR of 38%; of these, the 16 patients enrolled in the Phase 2 expansion of Arm 1, had an ORR of 69% and a CR of 38%
• Durable responses have been observed with a median duration of response of 20.7 months for all patients in Arm 1
• Betalutin is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible
• No dose-limiting toxicity (DLT) was reported in Arm 4 (15 MBq/kg Betalutin plus 100 mg/m2 lilotomab pre-dosing) and this regimen demonstrated lower bone marrow toxicity than Arm 1, 2 and 3. Arm 4 is now enrolling patients to evaluate the higher dosing regimen of 20 MBq/kg Betalutin plus 100 mg/m2 lilotomab.
The Lymrit 37-01 study is a Phase 1/2 open label, dose escalation study investigating the optimal lilotomab pre-dosing and Betalutin regimen in patients with relapsed NHL. Data from 38 patients are presented.
Dr. Arne Kolstad, MD commented: "The results we are presenting today are very encouraging and continue to highlight the potential of Betalutin to provide a new treatment option for NHL patients. These patients, particularly those who fail standard CD20-targeted immunotherapy and/or are too frail to receive chemotherapy, are desperately in need of alternative therapies that work through different and complementary mechanisms and are well tolerated. Betalutin is showing exciting promise in an increasing number of NHL patients and we look forward to the results from future studies that will hopefully confirm its attractive profile."
Dr. Lisa Rojkjaer, MD Nordic Nanovector’s Chief Medical Officer, commented: "These new data confirm the promising results for Betalutin, including durable responses in a number of patients, which were presented earlier this year at the AACR (Free AACR Whitepaper) meeting, and continue to demonstrate an encouraging clinical profile as a single agent for treating patients with relapsed NHL. The results also support escalating to a higher dosing regimen in the final stages of this Phase 1/2 study that will allow us to decide an optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017."
The poster (abstract 1780) is available at: View Source