ArticleNeuro-oncology advances
A single-arm phase 2 study of abemaciclib in adult patients with recurrent grade 3 oligodendroglioma.
Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Novel treatments are needed for oligodendroglioma that has recurred following radiotherapy (RT) and chemotherapy. The cyclin D1-CDK4 axis is frequently dysregulated in oligodendroglioma. Abemaciclib is a selective CDK4/6 inhibitor that achieves pharmacologically relevant concentrations in brain tumor tissue. Methods: We conducted a single-arm, phase 2 trial evaluating the efficacy of abemaciclib in patients with recurrent oligodendroglioma, isocitrate dehydrogenase (IDH)-mutant and 1p/19q-codeleted, WHO grade 3, following prior RT and ≥1 line of alkylating chemotherapy. Patients received abemaciclib 200 mg twice daily. The primary endpoint was progression-free survival at 6 months (PFS-6). Results: Ten patients were enrolled. The most common treatment-related adverse event was grade 1-2 diarrhea, occurring in all patients. Five patients (50%) were alive and progression-free at 6 months, below the minimum required (80%) to meet the primary endpoint. In patients with enhancing tumor ( Conclusions: The efficacy of abemaciclib in recurrent grade 3 oligodendroglioma was inadequate to warrant further evaluation as monotherapy in unselected patients. However, given the objective responses and durable disease control observed in a subset of patients, further studies are warranted to identify subgroups that may benefit.
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