Drug updated on 4/16/2024
| Dosage Form | Injection (subcutaneous; 62 mg as a lyophilized powder in a single-dose vial for reconstitution) |
| Drug Class | Hematopoietic stem cell mobilizers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
Summary
- Motixafortide (Aphexda) is indicated for use in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. The GENESIS study demonstrated a significant superiority of Aphexda + G-CSF over placebo + G-CSF, indicating a marked improvement in stem cell mobilization efficiency.
- Two randomized controlled trial studies were reviewed, providing comprehensive insights into the safety and effectiveness of Aphexda, especially when compared to the current standard treatment for mobilizing hematopoietic stem cells.
- Both studies focused on adult patients with multiple myeloma undergoing autologous hematopoietic stem cell transplantation. There was no mention of subgroup analyses within these patient populations based on age, disease stage, or previous treatment history.
- In terms of the safety profile, Aphexda demonstrated manageable adverse events primarily localized at the injection site such as pain, erythema, and pruritus. This suggests that it adds a tolerable safety profile when used alongside G-CSF compared to its standalone use, known for causing bone pain and leukocytosis.
- Compared directly against placebo + G-CSF during trials, Aphexda combined with G-CSF showed significantly improved efficacy in mobilizing a sufficient number of HSPCs required for a successful transplantation procedure among MM patients.
- While there is an implicit comparison suggesting superior performance by combining Aphexda + G-GSF than using only the standard treatment alone (given the placebo comparison), detailed comparative data against other CXCR4 inhibitors or other agents involved in similar procedures were not provided explicitly within the studies reviewed.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aphexda (motixafortide) Prescribing Information. | 2023 | BioLineRx Ltd., Modi’in, Israel |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial | 122Subjects F: 35% M: 65% | 2023 | Nature Medicine |
| Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma. | 134Subjects F: 36% M: 64% | 2019 | Future Oncology |
Sex Distribution:
F:35%
M:65%
122Subjects
Year:
2023
Source:Nature Medicine
Document Title
Sex Distribution:
F:36%
M:64%
134Subjects
Year:
2019
Source:Future Oncology