Results of the Most Comprehensive Study Evaluating Immunotherapy in the Brain Tumor GBM

Glioblastoma multiforme (GBM) is the most common primary (originating in the brain) brain tumor in adults (explained in detail in the presentation below). Its rapid progression and lack of a definitive cure adversely affect survival in patients diagnosed with GBM.

Treatments that activate the immune system against tumors and have already been approved for many types of cancer, known as immunotherapies, are also being actively investigated for GBM. Studies have shown that immune cells enter the central nervous system (the brain), multiply and carry out their functions, and that antigen-presenting cells stimulate T cells to become active. All these findings from animal experiments suggest that immune checkpoint inhibitors, a new generation of immunotherapies, could be a good option for treating GBM.

Nivolumab (Opdivo) is a monoclonal antibody and a PD-1 immune checkpoint inhibitor. Its use in GBM aims to enable immune cells to recognize glioblastoma cells and mount a response against them. In patients with recurrent GBM, nivolumab’s safety was demonstrated in phase-I clinical trials. Subsequently, to investigate the efficacy of nivolumab and another drug used in GBM, bevacizumab, a phase III clinical trial was conducted for the first time.

The CheckMate-143 Study

The main question of the study was: "Does the PD-1 immune checkpoint inhibitor nivolumab improve overall survival compared with bevacizumab in patients with recurrent GBM?".

• A total of 369 patients with recurrent glioblastoma were included in the study for this purpose.
• The main finding was that nivolumab did not provide a survival advantage over bevacizumab in patients with recurrent GBM: median overall survival was 9.8 months in the nivolumab arm and 10 months in the bevacizumab arm.
• During the study, fatigue was the most common adverse event, affecting 18.1% of patients treated with nivolumab, while hypertension was the most common adverse event in 15.2% of patients receiving bevacizumab.

In conclusion, although the number of patients in this phase-III clinical trial remained in the 300s, immunotherapy appears not to have provided an advantage over the standard treatment, bevacizumab, in "recurrent" GBM. Studies are ongoing to evaluate nivolumab together with radiotherapy and temozolomide chemotherapy in newly diagnosed patients with a methylated MGMT promoter, an important genetic alteration in GBM.

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