Nordic Nanovector provides an update on PARADIGME, its ongoing Phase 2b trial of Betalutin in 3rd-line relapsed/refractory follicular lymphoma.
Despite COVID has the company seen a significant improvement in the enrolment rate from approximately two to approximately five patients per month, it states. After the expected lessening of COVID restrictions plus the ongoing operational improvements, this rate could further increase to at least seven patients on average per month by late spring. 14 patients were enrolled from November 2020 to 17 February 2021 (three patients from August to November 2020), with visibility on increasing numbers of patients in screening. 73 patients were enrolled as of 17 February 2021 (59 enrolled as of 18 November 2020).
Improvement in the enrolment rate
In addition, following discussions with the US Food and Drug Administration and an internal review, the company believes that a robust clinical data set (safety and efficacy) to support a filing at the designated dosing regimen of 40/15 can be achieved with a reduction of the initially targeted population from 130 to 120 patients. On this basis, 47 more patients are required to complete PARADIGME for regulatory submission of Betalutin.
The trial protocol amendments that were submitted in Q3’2020 have now been approved in all of the 24 participating countries including the US. In addition, further initiatives have been implemented, especially in the US, to improve the enrolment rate by entering agreements with organisations that specialise on focused patient enrolment campaigns.
The recent improvement in the enrolment rate has been driven by these protocol amendments and the initiatives being implemented to facilitate trial execution. The company anticipates the enrolment rate to continue improving as the most recent initiatives pay back fully and the impact of COVID-19 recedes with restrictions lifting over time as the roll out of global vaccination programmes takes effect.
As a result, the company is more confident that it can deliver preliminary three-month top-line data from PARADIGME in H2’2021, it states.
“We are beginning to see an encouraging improvement in the enrolment rate for PARADIGME based on changes to the trial protocol and the initiatives we are implementing to improve the execution of the trial. We now have clarity from key regulators on the clinical data set that is expected as a basis for our filing. This clarity, in conjunction with the improving enrolment rate and the continuing recruitment initiatives, gives us confidence that we can meet our goal of having preliminary three-month top-line data in H2’ 2021,” says Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector.
Photo of Christine Wilkinson Blanc: Nordic Nanovector