Background
According to interim findings of a phase II trial, the combination of INO-5401, a T-cell–activating immunotherapy and INO-9012, an immune activator of a different kind with Libtayo (Cemiplimab, a PD-1 inhibitor which is indicated for the treatment of advanced and locally-advanced skin cancer) plus chemoradiation, demonstrated promising 6-month of stopping the cancer from growing in patients with newly diagnosed glioblastoma multiforme (GBM) that is methylated or unmethylated.
The trial was a multicenter study opened only in the US. The goal in this GBM trial was to increase progression-free and overall survival of patients facing a disease where neither the standard of care nor clinical outcomes have significantly advanced in decades.
Results
Of the 52 patients enrolled the study 80% MGMT-methylated patients and 75% of MGMT-unmethylated patients had their disease stopping from growing. These data exceed historical standard-of-care results with the standard protocols.
Safety
The combination demonstrated an acceptable safety profile.
The most common adverse events were elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and tumor inflammation/edema; there was one death not related to the treatment.
Immune-related adverse events were reported in 22 patients with the most common being elevations in ALT/AST and were most commonly reported in the first 9 weeks of treatment.
About Glioblastoma
Glioblastoma Multiforme, or GBM, is a type of cancer which originates in the brain and made of brain cells known as “gliomas.”
Gliomas are neuron supporting cells, constituting a part of the nervous system.
Glioblastoma tends to develop into a star shaped formation. They are particularly aggressive tumors with the potential to grow fast and spread to other parts of the brain relatively quickly.
Glioblastoma creates its own independent blood supply which feeds it, promoting its growth and even enabling it to invade additional areas of the brain and establish more foci, hence the name “multiforme.”
GBM is a stage 4 cancer and constitutes about 50% of all brain tumors among patients aged 18 and older. Glioblastoma does not metastasize outside the brain.
The existing therapies used for glioblastoma are not curative, and this is a source of the need for innovative and effective treatment strategies in order to fight the disease.
The National Cancer Institute, NCI, highlights the fact that for a certain group of glioblastoma patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.
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