Success for autologous transplantation in multiple myeloma patients

BioLineRx announced that hematopoietic stem cells (HSCs) mobilized by BL 8040 in combination with granulocyte colony-stimulating factor (G-CSF) were successfully engrafted in all 11 patients participating in the Part 1, lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase III trial comparing BL 8040 and G-CSF to G-CSF alone, in mobilization of HSCs for autologous transplantation in multiple myeloma patients.

These data follow previously announced successful mobilization data which led the Data Monitoring Committee (DMC) to recommend proceeding to the randomized placebo-controlled Part 2 of the study. Results of the first 11 patients show that 9/11 patients (82%) reached the primary endpoint threshold of greater than 6x106 CD34 cells/kg with only one dose of BL 8040 and in up to 2 apheresis sessions. Furthermore, 7/11 patients (64%) reached the threshold of greater than 6x106 CD34 cells/kg in a single apheresis session only. In addition, all 11 patients reached the desired threshold in 4 or less apheresis days, and for all patients with available data (9/11), successful engraftment with BL 8040 mobilized HSCs was observed, with time to engraftment and graft durability comparable to standard of care mobilization regimens.

The results, detailed in an abstract titled GENESIS - A Phase III Randomized Double-Blind, Placebo-Controlled Trial, Evaluating Safety and Efficacy of BL 8040 and G-CSF in Mobilization of HSCs for Autologous Transplantation in Multiple Myeloma were presented in an oral presentation at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation.

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