Dinutuximab beta is also used as a second line treatment for children with high-risk neuroblastoma; it was tested and is used with a longer and slower dosing regime, and is given on its own, although it may be combined with IL-2 if a stronger immune response is needed.
[9] More than 25% of children taking these drugs experienced pain, fever, hives, vomiting, diarrhea, bone marrow suppression causing loss of platelets, red blood cells, white blood cells, and albumin, hypotension, electrolyte imbalance including low sodium, potassium, and calcium, elevated transaminases, infusion reactions, and capillary leak syndrome.
[5] In clinical trials of dinutuximab, the maximum plasma concentration was 11.5 mcg/mL; the mean steady state volume distribution was 5.4 L; the clearance rate was 0.21 L/day; and the average half-life was 10 days.
[5][10] The version of dinutuximab made by United Therapeutics, and marketed under the brand name Unituxin, is manufactured via industrial fermentation using a murine myeloma cell line, SP2/0.
[11][12] Dinutuximab (originally called Ch14.18) was discovered by a group at University of California San Diego led by Alice Yu; this antibody and several others were brought into clinical trials funded by the National Cancer Institute.
[10][13] The NCI manufactured the mAbs for the Phase III trial[13] of Ch14.18 in combination with GM-CSF and IL-2, which was halted due to clear efficacy; the results published in 2009.
[13] In the meantime in Europe, oncologists and patient advocates wanted to have the drug available in Europe, and made efforts to obtain the cell line used to make it from United Therapeutics and the originating lab at the NCI itself; when those efforts failed they reached out to a group at Memorial Sloan Kettering that had generated an anti-GD2 mAb and was making at MSK for administration to patients there, but this didn't work out either.