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May 12, 2021

LoA Update: BioLineRx’s approval likelihood for motixafortide bolstered by 9 points in multiple myeloma after positive topline Phase III data

BioLineRx’s motixafortide saw a 9-point boost in its Likelihood of Approval (LoA) in the mobilisation of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

By Reynald Castañeda

BioLineRx’s motixafortide saw a 9-point boost in its Likelihood of Approval (LoA) in the mobilisation of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. This is due to positive topline results revealed on 4 May pertaining to the Phase III GENESIS trial, which studied motixafortide in combination with standard of care granulocyte colony stimulating factor (G-CSF).

Motixafortide’s LoA was 34%, which rose to 43%, as of 6 May, as per GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. In GENESIS, in the 122 intent-to-treat cohort, there is a 4.9-fold increase in the proportion of motixafortide/G-CSF patients mobilising ≥6 million CD34+ cells/kg in up to two apheresis sessions, the trial’s primary endpoint. This contrasts with patients who received placebo plus G-CSF. Motixafortide is a CXCR4 antagonist.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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