期刊
NEURO-ONCOLOGY
卷 17, 期 6, 页码 854-861出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/neuonc/nou348
关键词
ACT III; EGFRvIII; glioblastoma; glioma; rindopepimut
资金
- Celldex Therapeutics, Inc.
Background. The epidermal growth factor receptor variant III deletion mutation, EGFRvIII, is expressed in similar to 30% of primary glioblastoma and linked to poor long-term survival. Rindopepimut consists of the unique EGFRvIII peptide sequence conjugated to keyhole limpet hemocyanin. In previous phase II trials (ACTIVATE/ACT II), rindopepimut was well tolerated with robust EGFRvIII-specific immune responses and promising progression-free and overall survival. This multicenter, single-arm phase II clinical trial (ACT III) was performed to confirm these results. Methods. Rindopepimut and standard adjuvant temozolomide chemotherapy were administered to 65 patients with newly diagnosed EGFRvIII-expressing (EGFRvIII+) glioblastoma after gross total resection and chemoradiation. Results. Progression-free survival at 5.5 months (similar to 8.5 mo from diagnosis) was 66%. Relative to study entry, median overall survival was 21.8 months, and 36-month overall survival was 26%. Extended rindopepimut vaccination (up to 3.5+ years) was well tolerated. Grades 1-2 injection site reactions were frequent. Anti-EGFRvIII antibody titers increased >= 4-fold in 85% of patients, and increased with duration of treatment. EGFRvIII was eliminated in 4/6 (67%) tumor samples obtained after >3 months of therapy. Conclusions. This study confirms, in a multicenter setting, the preliminary results seen in previous phase II trials of rindopepimut. A pivotal, double-blind, randomized, phase III trial (ACT IV) is under way.
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