By Estel Grace Masangkay
Researchers from the St. Jude’s Children Research Hospital reported that its investigational monoclonal antibody shrank tumors and halted disease progression in 15 children with advanced neuroblastoma enrolled in a safety study.
The experimental antibody hu14.18K322A was produced at the research hospital to identify and bind to specific markers found on the cell surface. The monoclonal antibody was evaluated for safety and efficacy in the dose-finding Phase I study in patient volunteers whose cancer has recurred or failed to respond to traditional treatment, and for whom neuroblastoma includes bone marrow transplants, surgery, chemotherapy, and radiation.
Trial participants received one of nine different doses of the antibody and received an infusion of hu14.18K322A once daily for four days. Of the 31 who underwent two or more treatment rounds, nine patients saw the disease stabilize, two patients saw a reduction in tumor size, and four patients did not report any tumors. These four patients are reported to be alive after more than two and a half years without taking additional therapy.
Fariba Navid, an associate member of the St. Jude Department of Oncology and corresponding author of the study, said, “This was the first time this experimental antibody was tried in patients. We were encouraged with the response. The percentage of patients who benefited from treatment with hu14.18K322A was unusual for a Phase 1 study.”
Neuroblastoma is a cancer of the sympathetic nervous system and is responsible for 7 to 10 percent of childhood cancers. Childhood neuroblastoma is most commonly diagnosed in the first year of a patient’s life. Less than half of high-risk patients with neuroblastoma experience long term, disease free survival, which emphasizes the current need for new treatment options.
Hu14.18K322A is an antibody that targets and binds to GD2 antigen found on the surface of all neuroblastoma cells as well as other tumors such as bone cancer osteosarcoma, soft-tissue sarcomas, and skin cancer melanoma. GD2 is also found on normal cells but only on a few tissues. The antibody is designed to minimize risk of rejection by the body and is produced in a cell line that may improve its tumor cell-killing abilities.
Clinical trials of hu14.18K322A are underway at St. Jude hospital, where researchers are investigating the impact of weekly administration instead of every 4 weeks, and in combination with other therapies. Results of the study were published online and will appear in the Journal of Clinical Oncology.