Transcript

My name is Dr Claire Verschraegen. I'm a professor at the Ohio State Comprehensive Cancer Center. I'm the chief of the medical oncology division. My specialty is really rare tumors and drug development.

I'm now going to discuss a very interesting study by a group at MD Anderson—the first author was Isabella Glitza—about injecting nivolumab intrathecally for patients with metastatic melanoma that have leptomeningeal disease.

Currently, I am in fact treating melanoma and other skin cancers at Ohio State, so this is quite in the area that I'm an expert at this time. This is a very interesting study, because usually 30% of patients with melanoma will develop some type of metastatic disease to the brain, whether intraparenchymal or leptomeningeal disease, which is always difficult to treat.

We know that some of those now, with the new therapies that we have available for melanoma, like BRAF inhibitors and immunotherapy monoclonal antibodies, do respond with systemic therapy, but it's not a 100% response.

The group at MD Anderson decided to do dose-finding and really a schedule-finding study about nivolumab, injecting it intrathecally as well as systemically to really boost the concentration of the antibody in the CSF and brain system.

They had experience doing that with interleukin-2, with a good response for patients with leptomeningeal disease, and wanted to see if the administration of nivolumab was going to be helpful.

This is not really a study to look at response rate, but mainly to look at toxicities and find the patient that will respond and try to understand what's the next step in pursuing such type of administration.

They have very few side effects, compared to systemic nivolumab, only 1 grade 3 nausea; all the other reported side effects were of grade 1. That was really interesting. Some drugs are totally toxic when injected intrathecally, so one must be very careful, even with monoclonal antibodies.

They had one good responders, in fact, at the lowest dose of nivolumab that they injected intrathecally. Another few had stable disease, but the study is still ongoing. So this was really preliminary report on this type of therapy.

Definitely something to watch if you treat melanoma, because it may eventually become a standard of care.

Thank you very much.