Nordic Nanovector to Conduct a Comprehensive Review and Independent Data Evaluation of PARADIGME, its Phase 2b Trial with Betalutin® in R/R FL as a Result of Continuing Slow Recruitment
Oslo, Norway, 2 June 2022
Nordic Nanovector ASA (OSE: NANOV) today provides an update on PARADIGME, its ongoing Phase 2b trial of Betalutin® (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL).
As highlighted at the recent Q1 results, reported on 13 May 2022, recruitment into PARADIGME has been slower than anticipated, and despite ongoing efforts by the company this has continued into Q2 with no additional patients enrolled in May.
As a result, the Board of Nordic Nanovector has decided to conduct a comprehensive review of all aspects of the PARADIGME study. In order to fully protect the integrity of the study an independent evaluation of the data collected to date has been commissioned and will be analysed by an Independent Expert Panel. This information will then be used to determine the best path forward for the study. PARADIGME will continue to enrol patients while the independent evaluation is ongoing.
The current guidance for delivery of initial top line data from PARADIGME in the second half of this year will be reviewed concurrently.
The Board expects to report on the findings of the review of PARADIGME no later than the Q2 results to be released on 20 July 2022 and will not be commenting further until the review is complete.
The Board believes that this review of PARADIGME is in the best interests of all shareholders and the patients who Nordic Nanovector is targeting in this study to determine the optimal path forward for Betalutin® within a timeframe that is financially and commercially viable.