BioLineRX (BLRX) soared 60% on news that the company had released positive data from GENESIS Phase 3 Trial of Motixafortide in Stem-Cell Mobilization for Autologous Bone Marrow Transplantation in Multiple Myeloma Patients.
They state that the study met all primary and secondary endpoints with exceptionally high level of statistical significance and 88.3% of patients receiving Motixafortide + G-CSF underwent transplantation after only ONE apheresis session, compared to 10.8% for G-CSF alone; supports Motixafortide on top of G-CSF as new standard of care in this indication.
An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF. In addition, the combination was found to be safe and well tolerated.
Other important data from the study include median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs 1.5 million in the control arm) – a 5.6-fold increase. The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. Engraftment endpoints, including the number of days needed for engraftment, success of engraftment and the durability of engraftment 100 days post-transplant, further support the study’s success.