A novel approach to administer intrathecal (IT) immunotherapy (directly into the spinal fluid) and intravenous (IV) immunotherapy was safe and improved survival in a subset of patients with leptomeningeal disease (LMD) from metastatic melanoma, according to interim analyses of a Phase I/Ib trial led by researchers at The University of Texas MD Anderson Cancer Center.
The study, published today in Nature Medicine, represents the first-in-human trial of concurrent IT and IV nivolumab (anti-PD-1) in melanoma patients with LMD. Across 25 patients, the median overall survival (OS) was 4.9 months, with OS rates of 44% at 26 weeks and 26% at 52 weeks. Four patients survived to 74, 115, 136 and 143 weeks after their first IT dose, which is significantly longer than expected.
“This represents a major path forward for our patients, as there is a crucial unmet clinical need for better treatments for patients with LMD,” said corresponding author Isabella Glitza Oliva, M.D., Ph.D., associate professor of Melanoma Medical Oncology. “We are encouraged by these preliminary results for a disease that has been notoriously difficult to study due to its highly aggressive nature. This approach is safe, and we’re seeing a small subset of our patients who have had outstanding results, so we hope to learn from each and every one of them.”
