Motixafortide regimen shows ‘impressive’ activity in transplant setting for myeloma
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The addition of motixafortide to standard treatment improved hematopoietic stem cell target mobilization for autologous bone marrow transplantation among patients with multiple myeloma, according to the agent’s manufacturer.
The randomized phase 3 GENESIS trial included 122 patients with multiple myeloma.
Patients received granulocyte colony-stimulating factor plus either motixafortide (BL-8040, BioLineRx Ltd.) or placebo.
Researchers’ primary objective was to demonstrate that one dose of motixafortide plus G-CSF would prove superior to G-CSF alone in its ability to mobilize at least 6 million CD34-positive cells in up to two apheresis sessions. Other objectives included time to engraftment of neutrophils and platelets, durability of engraftment, and other safety and efficacy measures.
The study met its primary endpoint, as a significantly higher percentage of patients assigned the experimental regimen mobilized at least 6 million CD34-positive cells/kg in up two apheresis sessions (70% vs. 14.3%; difference, 54.6%; 95% CI, 39.7-69.5; OR = 12.9).
The study also met its secondary endpoint, as a higher percentage of patients assigned the experimental regiment mobilized at least 6 million CD34-positive cells/kg in just one apheresis session (67.5% vs. 4.8%; difference, 61.7%; 95% CI, 49.5-73.8; OR = 56).
The median number of CD34-positive cells collected on the first day of apheresis was more than five times greater in the motixafortide group (8.5 million vs. 1.5 million).
Eight times as many patients assigned the experimental regimen underwent transplantation after only one apheresis session (88.3% vs. 10.8%).
Results of engraftment endpoints, including number of days needed for engraftment and engraftment durability at 100 days after transplant, also favored the motixafortide regimen.
“The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session,” lead investigator John DiPersio, MD, deputy director of Siteman Cancer Center and chief of the division of oncology at Washington University School of Medicine in St. Louis, said in a BioLineRx-issued press release. “This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation.”
BioLineRx officials are “working aggressively” to obtain regulatory approval for motixafortide in this setting and expect to submit a new drug application in the first half of next year, according to Philip Serlin, the company’s CEO.
“These strikingly positive data significantly exceeded our expectations,” Serlin said in the release. “The statistical significance across all primary and secondary endpoints was consistent across 12 different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.”
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