BioLineRx has revealed results from Phase lll GENESIS trial of motixafortide combined with granulocyte colony-stimulating factor (G-CSF) against placebo plus G-CSF for mobilising hematopoietic stem cells to treat multiple myeloma patients before autologous stem cell transplantation (ASCT).
The data showed that the trial achieved statistical significance across all of its primary and secondary endpoints.
GENESIS was an international, double-blind, randomised, placebo-controlled, multicentre trial designed to assess the efficacy and safety of motixafortide and G-CSF, against placebo and G-CSF.
Its primary objective was to show that one motixafortide dose with G-CSF, in comparison with placebo with G-CSF, enabled more patients to mobilise ≥ six million CD34+ cells in one kilogram of bodyweight, in up to two apheresis sessions.
The trial’s secondary objective was to exhibit that one dose of motixafortide with G-CSF was better than placebo with G-CSF in mobilising more than six million CD34+ cells per kilogram of bodyweight in one session.
Other objectives of the trial were time to engraftment of neutrophils and platelets as well as durability of engraftment.
The motixafortide-plus-G-CSF regimen demonstrated fast and durable engraftment of hematopoietic stem and progenitor cells (HSPCs) after transplantation.
The therapy regimen was also found to have a promising safety-profile.
It was generally well-tolerated, with the most frequent adverse events related to the treatment being transient, grade 1/2 injection site reactions.
The trial also included parallel comparative FACS and single-cell transcriptional profile evaluation that are based on GENESIS data and results from trial cohorts with other mobilisation regimens.
GENESIS trial principal investigator John DiPersio said: “Despite improvements in survival that ASCT offers patients with multiple myeloma, there has not been significant innovation in stem cell mobilisation treatments in over a decade.
“With today’s increased use of multiple drug induction therapies and transplants in increasingly older patients, there is a corresponding increased need for new treatment options.
“These data highlight the potential of motixafortide plus G-CSF, if approved, to enhance the treatment options for clinicians and patients with multiple myeloma undergoing ASCT.”