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A recently published Phase 1/2a study evaluated Lisavanbulin, an oral microtubule-targeting agent, in patients with recurrent glioblastoma (GBM) and other high-grade gliomas (HGGs). In the Phase 1 trial, 28 patients received daily Lisavanbulin at doses up to 30 mg. Among them, one patient had a confirmed complete response (CR) and one had a confirmed partial response (PR) with 94% tumor shrinkage; both remained on therapy for over four years. An additional seven patients had stable disease, yielding a disease control rate (DCR) of 32.1%. However, median progression-free survival (PFS) was just 1.6 months, and only 11.2% of patients remained event-free at 12 months.
In the Phase 2a expansion, 13 patients with recurrent GBM were pre-selected based on EB1 protein expression, a potential biomarker of response. Of nine with measurable disease, one patient had a durable PR and four had stable disease, for a DCR of 55.6%. Overall, the 12-month event-free survival was 32.5%, and 12-month overall survival was 55.6%, but the study did not meet its pre-specified efficacy threshold and was closed to further recruitment. Follow-up studies are planned to investigate why a small subset of patients had such exceptional and durable responses, with a focus on refining EB1 as a predictive biomarker to better identify likely responders.