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This trial compared a combination of two immune checkpoint inhibitors (ICIs), ipilimumab plus nivolumab, versus standard temozolomide in patients with newly diagnosed MGMT-unmethylated glioblastoma (GBM). We had high hopes for this one, but unfortunately, preliminary results showed there was no improvement in progression-free survival (7.7 months with the combination vs. 8.5 months with TMZ). Early overall survival data also showed no difference, so the trial has been stopped. Follow-up and biomarker analyses are ongoing to explore potential subgroups that may benefit from this immunotherapy combination.
So far, studies using ICIs in GBM generally have not had great results. However, we're hopeful they will still have a role to play, perhaps with a better understanding of molecular feature selection and/or when given in the neoadjuvant setting. We are also very hopeful for the Phase 3 EF-41 trial, which is testing the combination of the ICI pembrolizumab (Keytruda) together with tumor treating fields (Optune Gio); this combination acheived significantly improved median survival (24.8 vs. 14.6 months) in the Phase 2 "2-THE-TOP" trial for newly diagnosed GBM, especially for patients who only had biopsy and were not eligible for resection (31.6 vs. 18.8 months).