Nordic Nanovector ASA announces the Safety Review Committee (SRC) for the ongoing LYMRIT 37-01 clinical trial of Betalutin in non-Hodgkin's Lymphoma (NHL) has reviewed safety data from the study and approved continued clinical evaluation of 20 MBq/kg Betalutin administered after pre-dosing with 100 mg/m2 lilotomab.
Following the SRC's recommendation, new patients will be enrolled into a Phase 2 expansion cohort of Arm 4 in Betalutin's Phase 1/2 study LYMRIT 37-01, to continue the collection of safety and efficacy data of 20 MBq/kg Betalutin after pre-dosing with 100 mg/m2 lilotomab. This will enable the company to build a robust database of clinical data to confirm the optimal dosing regimen for the pivotal Phase 2 PARADIGME study, which is on track to start in the second half of 2017.
"This recommendation from the SRC represents another important milestone for the development of Betalutin, in line with our strategy and established timelines,” Luigi Costa, Nordic Nanovector CEO, said. “It supports the hypothesis that a higher pre-dosing regimen may enable the use of a higher dose of Betalutin. The enrolment of new patients in Phase 2 provides the opportunity to collect additional safety and preliminary efficacy data to support the selection of the dosing regimen we will use in PARADIGME later this year."
The LYMRIT 37-01 study is an ongoing Phase 1/2 open label, dose-escalation study with four treatment arms in patients with relapsed NHL to establish the recommended dosing regimen of single-dose Betalutin for Phase 2. The study is investigating three doses of Betalutin and different pre-dosing regimens with the aim of identifying an optimal dose regimen to take into a pivotal Phase 2 PARADIGME trial.
The most recent results were presented at the American Society of Hematology (ASH) annual meeting in December 2016 and showed:
- Significant anti-tumour activity observed: ORR of 62%, CR 38% in Arm 1 patients receiving 15MBq/kg; consistent for 16 patients treated in Arm 1/Phase 2 (ORR 69%, CR 38%)
- Durable responses observed: median duration of response of 20.7 months for patients in Arm 1
- Well tolerated with a predictable and manageable safety profile