Intrathecal (IT), intravenous (IV), and Nivolumab (anti-PD-1) immunotherapy were found to be safe and prolong life in a subset of melanoma individuals with leptomeningeal illness (LMD).
The interim evaluations of the innovative delivery strategy were presented in the first-in-human Phase I/Ib research that was published in Nature Medicine.
Leptomeningeal illness happens to be a cancer complication that arises when cancer cells from primary tumours travel into the cerebrospinal fluid (CSF) and leptomeninges, which are the outer coverings of the brain and spinal cord. These cells can rapidly expand all across the CSF, causing a wide range of neurological symptoms.
The immunotherapy study’s findings
Among the 25 sufferers, the median overall survival (OS) was 4.9 months. At 26 weeks, the OS rate was 44%, and at 52 weeks, it was 26%. Four patients stayed alive for 74, 115, 136, and 143 weeks after their primary IT treatment, which is significantly longer than anticipated. Except for all patients, two had previously had systemic therapy.
A prior proof-of-concept study established that IT injection of interleukin-2 across LMD patients showed that injecting nivolumab directly into spinal fluid increased its concentration inside the CSF, despite the fact that these antibodies cannot easily cross the blood-brain barrier (BBB). While patients saw positive outcomes, the medication was accompanied by substantial side effects.
Associate Professor of Melanoma Medical Oncology, Ph.D., Dr. Isabella Glitza Oliva, remarked that until this present study, there have been very limited resources in clinical trials for this space, and the researchers are hopeful that these findings, gelled with future clinical trials, will lead towards a better know-how of LMD and, eventually, put forth more effective ways of assisting the patients. A dose-expansion group has already finished enrolment for the research that is coming up.