BioLineRx announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of 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.
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"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," said Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."
The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.