Safety Review Committee For Nordic Nanovector's Lymrit 37-01 Trial Recommends Dose Escalation To 20 MBq/kg With Betalutin
11/4/2016 3:52:08 PM
Oslo, Norway, 4 November 2016
Nordic Nanovector ASA (OSE: NANO) announces that the independent Safety Review Committee (SRC) for the ongoing Lymrit 37-01 clinical trial of Betalutin® in relapsed/refractory NHL, has recommended escalating the dose of Betalutin® in Arm 4 from 15 MBq/kg to 20 MBq/kg following pre-dosing with 100 mg/m2 lilotomab. Recruitment of 3 patients into Arm 4 to receive this new higher dosing regimen is now underway. The SRC also concluded that Arm 3 should be discontinued.
The decision follows a review by the SRC of the available safety and dosimetry data from the first cohorts of 3 patients each enrolled in Arms 3 and 4 to determine which arm should continue, if dose escalation is warranted and to what extent. Patients in Arm 3 were pre-dosed with standard rituximab immunotherapy prior to receiving 15 MBq/kg Betalutin®; patients in Arm 4 received 100 mg/m2 lilotomab prior to 15 MBq/kg Betalutin®.
The SRC recommendation for advancing Arm 4 was based on safety data demonstrating that pre-dosing with 100 mg/m2 lilotomab prior to Betalutin® reduces bone marrow toxicity as a result of lower absorbed radiation dose to this tissue. In addition, available dosimetry data from Arm 4 showed that higher pre-dosing does not prevent therapeutically relevant amounts of Betalutin® being taken up into the tumours.
Update on dose escalation in Arm 1/Phase 2
The SRC has also agreed that the company can change the treatment regimen used in Arm 1/Phase 2 to match that used in Arm 4. The dose of Betalutin® specified in Phase 2 will be increased from 15 MBq/kg to 20 MBq/kg pending review of the safety data from the first 3 patients treated in Arm 4 with 20 MBq/kg.
Escalation to the new higher dosing regimen in Arm 1/Phase 2 will also require the approval of a protocol amendment by the European regulators. The planned amendment will allow for additional patients to be enrolled into Arm 1/Phase 2, which is expected to contribute to building a more robust safety database, particularly with data from patients receiving the new higher dosing regimen.
Luigi Costa, Nordic Nanovector CEO, commented: “This is an important milestone in the development of Betalutin® in FL. We are delighted with outcome of the SRC review that provides us with the opportunity to test a higher dose of Betalutin®. We believe that the new dosing regimen will deliver an even higher efficacy than that so far observed and favourable safety, based on the evidence to date. We are confident that we will meet our goal of having a clear view on the optimum dosing regimen to use in the pivotal PARADIGME trial by the end of the first quarter 2017 as planned.”
About Lymrit 37-01
The LYMRIT 37-01 study is an ongoing Phase 1/2 open label, single injection ascending dose study investigating in three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into a pivotal Phase 2 PARADIGME trial.
Updated results from the Lymrit 37-01 trial including those in Arms 3 and 4, will be presented at the 58th Annual American Society of Hematology (ASH) meeting on 3 December 2016.
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