Patients with newly diagnosed glioblastoma do not experience any prolongation in survival if treated with rindopepimut, according to a study published in The Lancet Oncology.1
In a randomized phase 3 ACT IV trial (ClinicalTrials.gov Identifier: NCT01480479), 405 patients with minimal residue disease (MRD), 338 patients with significant residual disease (SRD), and 2 unevaluable patients, were assigned to receive temozolomide 150 mg/m2 to 200 mg/m2 with rindopepimut 500μg or with control (100μg keyhole limpet haemocyanin).
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At the preplanned interim analysis, the study was discontinued for futility.
No differences were observed for overall survival (OS) at time of final analysis for patients with MRD; median OS was 20.1 months (95% CI, 18.5-22.1) in the study group compared with 20.0 months (95% CI, 18.1-21.9) in the control group.
Nine patients in the rindopepimut group and 7 patients in the control group died due to adverse events (AE), of which only 1 was potentially associated with rindopepimut.
The most frequently reported grade 3 to 4 AEs in the rindopepimut arm and the control group, respectively, were thrombocytopenia (9% vs 6%), fatigue (2% vs 5%), brain edema (2% vs 3%), seizure (2% vs 2%), and headache (2% vs 3%). Reported serious AEs include seizure (5% vs 6%), and brain edema (2% vs 3%).
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Despite the results, authors concluded by saying “combination approaches potentially including rindopepimut might be required to show efficacy of immunotherapy in glioblastoma.”
Reference
- Weller M, Butowski N, Tran DD, et al. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Aug 22. doi: 10.1016/S1470-2045(17)30517-X