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Published on: October 27, 2014
A single-arm phase 2 study of abemaciclib in adult patients with recurrent grade 3 oligodendroglioma
Carson A Wills1, Suyash Mohan2, Ali Nabavizadeh2
1Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
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 (n = 9), best response was partial response in 2 patients (objective radiographic response = 22.2%; duration of response [DOR] 13.1 and 7.7 months), stable disease (SD) in 3 patients (33.3%; duration of SD 17.0, 6.7, and 2.5 months), progressive disease in 3 patients (33.3%), and nonevaluable in 1 patient (11.1%). The patient with nonenhancing tumor showed SD lasting 10.2 months. Median PFS was 7.7 months (95% CI, 1.7-13.1 months); median overall survival was not reached (median follow-up 17 months).
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.
Insights
Abemaciclib showed limited efficacy as a single treatment for recurrent oligodendroglioma. While some patients experienced partial responses, the overall progression-free survival did not meet the trial
Area of Science:
- Neuro-oncology
- Molecular targeted therapy
- Clinical trial research
Background:
- Recurrent oligodendroglioma requires novel treatments.
- The cyclin D1-CDK4 pathway is often dysregulated in oligodendroglioma.
- Abemaciclib, a CDK4/6 inhibitor, reaches therapeutic levels in brain tumors.
Purpose of the Study:
- To evaluate abemaciclib efficacy in recurrent, IDH-mutant, 1p/19q-codeleted, WHO grade 3 oligodendroglioma after radiotherapy and chemotherapy.
- To assess progression-free survival at 6 months (PFS-6) as the primary endpoint.
Main Methods:
- Single-arm, phase 2 clinical trial.
- 10 patients with recurrent oligodendroglioma received abemaciclib 200 mg twice daily.
- Primary endpoint: PFS-6.
Main Results:
- 50% of patients were progression-free at 6 months, below the target of 80%.
- Objective radiographic response rate was 22.2% in patients with enhancing tumors.
- Median PFS was 7.7 months; median overall survival was not reached.
Conclusions:
- Abemaciclib monotherapy showed inadequate efficacy for unselected recurrent oligodendroglioma patients.
- Further research is needed to identify patient subgroups who may benefit from abemaciclib.
- Objective responses and disease control in a subset suggest potential for targeted investigation.
