New Combination Therapy Shows Promising Results in Phase 3 GENESIS Trial
The FDA has given the green light to motixafortide in combination with filgrastim for the mobilization of hematopoietic stem cells in patients with multiple myeloma. This approval opens up a new avenue for improving the success rates of autologous stem cell transplantation (ASCT), a cornerstone in the treatment of this type of cancer.
HCN Medical Memo
The FDA approval of motixafortide offers a promising new tool for improving the efficacy of ASCT. The robust data from the GENESIS trial suggests that this combination therapy can significantly enhance stem cell mobilization, thereby potentially improving patient outcomes. However, it’s crucial to consider the risk of adverse reactions and to monitor patients closely during treatment.
- The FDA approval is based on the GENESIS trial, a two-part, randomized, double-blind, placebo-controlled study.
- Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 10^6 CD34+ cells/kg within two apheresis sessions, compared to 9.5% for the placebo plus filgrastim regimen.
- Serious adverse reactions occurred in 5.4% of patients receiving motixafortide plus filgrastim, including vomiting, injection site reaction, and hypersensitivity.
- Healthcare professionals emphasize the importance of adequate stem cell mobilization for the success of ASCT in multiple myeloma patients.
In the GENESIS trial, motixafortide plus filgrastim enabled patients to mobilize more than four times the amount of stem cells with a single dose over a 24-hour period compared to placebo plus filgrastim.
- The American Society for Transplantation and Cellular Therapy recommends a collection target of 3-5 × 10^6 CD34+ cells/kg for ASCT.
- Up to 47% of patients have historically faced challenges in collecting adequate numbers of stem cells for ASCT.
- The GENESIS study included a median age of 63 years and ~70% of patients receiving lenalidomide-containing induction therapy.
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