Nordic Nanovector to Seek Regulatory Feedback Following its Preliminary Review and Independent Data Evaluation of PARADIGME, its Phase 2b Trial with Betalutin® in R/R Follicular Lymphoma
Nordic Nanovector ASA (OSE: NANOV) today provides an update following its comprehensive review and independent data evaluation of 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).
The independent expert panel reviewed the efficacy data collected to date. Betalutin®, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile. While Betalutin® showed signs of efficacy in this frail, elderly and difficult-to-treat patient population, the independent expert panel reported that the efficacy data are less promising than the data reported from the Phase 2a LYMRIT 37-01 trial. The Company intends to seek further guidance from the competent regulatory authorities, including the US Food and Drug Administration (FDA), regarding the way forward for PARADIGME. Pending regulatory feedback, the study will remain open for recruitment.
Following interaction with the regulatory authorities, the Company will provide an additional update, which is expected in August. The Company will not be commenting further until then. The Company's Q2 results will be rescheduled to August and a new date will be confirmed in due course.
Given the continuing slow patient recruitment, Nordic Nanovector does now not expect to deliver preliminary top line data from PARADIGME in H2 2022.