About Mozobil

Mozobil + granulocyte-colony stimulating factor (G-CSF) has been shown to improve mobilization compared to G-CSF alone by increasing predictability of cell number and timing in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).1-3

Indication and Usage

Mozobil 1

Mozobil is indicated in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with NHL and MM.1

Mozobil is a first in class CXCR4 receptor antagonist.

Mozobil + G-CSF Decreased the Number of Apheresis Days1

Study Design

Two phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of Mozobil (0.24 mg/kg) + G-CSF (10 μg/kg) vs placebo + G-CSF (10 μg/kg) in patients with MM (N=302) or NHL (N=298)1-3

Primary End Point

Percentage of Patients With MM Who Achieved ≥6 x 10^6 CD34+ cells/kg in Two or Fewer Days of Apheresis1,3

chart showing the percentage of patients with MM who achieved less than or equal to 6x10 CD34 cells/kg in two or fewer days of apheresis

Percentage of Patients With NHL Who Achieved ≥5 x 106 CD34+ cells/kg in Four or Fewer Days of Apheresis1,2

chart showing the percentage of patients with NHL who achieved less than or equal to 5x10 CD34 cells/kg in four or fewer days of apheresis

Mozobil + G-CSF demonstrated an approximately 5-fold increase in circulating CD34+ cells in the peripheral blood of patients with MM and NHL2,3

Mozobil 1

Secondary End Point

Kaplan-Meier Estimate of the Proportion of Patients With MM Who Achieved ≥6 x 106 CD34+ cells/kg, by Apheresis Day3

Graph showing Kalplan-Meier estimate of the percentage of MM patients who achieved less than or equal to 6 x 10 CD34 cells/kg, by Apheresis day.

>50% of patients with MM achieved ≥6 x 106 CD34+ cells/kg in 1 day with Mozobil + G-CSF vs 4 days with G-CSF alone1

Kaplan-Meier Estimate of the Proportion of Patients With NHL Who Achieved ≥5 x 106 CD34+ cells/kg, by Apheresis Day2

Graph showing Kalplan-Meier estimate of the percentage of NHL patients who achieved less than or equal to 5 x 10 CD34 cells/kg, by Apheresis day.

>50% of patients with NHL achieved ≥5 x 106 CD34+ cells/kg in 3 days with Mozobil + G-CSF vs <30% reaching the collection target in 4 days with G-CSF alone1

Mozobil 1

Mozobil + G-CSF Allowed More Patients to Proceed to ASCT2,3

Secondary End Point: Post Hoc Analysis*

Percentage of Patients With MM Who Proceeded to HDT/ASCT Based on Their Mobilization Regimen3

chart showing percentage of patients with MM who proceeded to HDT/ASCT based on their mobilization regimen

Percentage of Patients With NHL Who Proceeded to HDT/ASCT Based on Their Mobilization Regimen2

chart showing percentage of patients with NHL who proceeded to HDT/ASCT based on their mobilization regimen

*Patients with MM or NHL receiving Mozobil + G-CSF vs patients receiving G-CSF alone, who underwent transplant based on achievement of a minimum number of collected cells.2,3

  • Multiple factors can influence time to engraftment and graft durability following ASCT1
  • For transplanted patients in the Phase 3 studies, time to neutrophil and platelet engraftment and graft durability were similar across the treatment groups1

Mozobil + G-CSF Has an Established Safety Profile1-3

Mozobil 1

Adverse Reactions in ≥10% of Patients With NHL and MM Receiving Mozobil + G-CSF or Placebo + G-CSF During HSC Mobilization and Apheresis1

Mozobil + G-CSF
(n=301)
Placebo + G-CSF
(n=292)
Adverse Reaction All Grades* (%) All Grades* (%)
Diarrhea 37 17
Nausea 34 22
Injection site reactions 34 10
Fatigue 27 25
Headache 22 21
Arthralgia 13 12
Dizziness 11 6
Vomiting 10 6

*Grades based on criteria from the World Health Organization.

Mozobil Reversibly Blocks the CXCR4/SDF-1α Interaction1

Diagram showing normal cells.
Diagram showing Mozobil treated cells.
  • Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1α or through the induction of other adhesion molecules1
  • As an inhibitor of the CXCR4 chemokine receptor, Mozobil reversibly blocks binding of its cognate ligand, SDF-1α1
  • This action allows the release of stem cells from the bone marrow into the circulating blood1
Mozobil 1

Dosing and Administration

See the details around recommended dosage and when to administer Mozobil.

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Support

Sanofi Patient Connection™ is a comprehensive program designed to assist your patients.

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References:

  1. Mozobil [prescribing information]. Cambridge, MA: Genzyme Corporation; 2017.
  2. DiPersio JF, Micallef IN, Stiff PJ, et al. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin’s lymphoma. J Clin Oncol. 2009;27(28):4767-4773.
  3. DiPersio JF, Stadtmauer EA, Nademanee A, et al; for 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009;113(23):5720-5726.