DMC rules GENESIS Phase III trial of BL 8040 enrollment complete in multiple myeloma patients.- BioLineRx

BioLineRx announced positive results from a planned interim analysis of the ongoing GENESIS Phase III trial of BL 8040 (motixafortide) for stem cell mobilization (SCM) in multiple myeloma patients. At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.