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The Phase 1 trial for oral gallium maltolate (GaM) in recurrent GBM is not yet complete but preliminary results were shared in a press release today. Oral GaM is taken in pill form daily and has demonstrated excellent tolerability, with no serious adverse events reported. Among the 23 patients in the study so far with evaluable data, overall survival was 14 months from GaM treatment initiation and 32 months from the time of initial diagnosis. Median overall survival for recurrent GBM is typically 8-9 months, so this represents a positive signal of response. It’s worth noting that this was a dose escalation study, so not all patients received the maximum dose.
The data also showed progression-free-survival (PFS) of 2 months, which is comparable to patients undergoing standard therapy for recurrence. PFS in the study was determined by standard radiologic (RANO) response criteria, which doesn’t always reliably distinguish tumor progression from treatment effect. The company that makes oral GaM has developed advanced imaging software called Fractional Tumor Burden mapping (FTB maps) that will hopefully provide more insight for imaging interpretation in the future. We have a webinar on FTB maps with Dr. Leland Hu coming up on May 15!