On August 3, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, AUG 3, 2021, View Source [SID1234585658]). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.
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The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.
The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.
While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.
Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.
In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin in 2L FL.
The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin and present other projects in its portfolio.
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible."