Phase II trial of SurVaxM combined with standard therapy in patients with newly diagnosed glioblastoma.

2041Background: To determine 6-month progression-free survival (PFS-6), 12-month overall survival (OS-12) and immunologic response in newly diagnosed glioblastoma (nGBM) treated with concurrent temozolomide (TMZ) and radiation, followed by adjuvant TMZ and survivin-targeted immunization with SurVaxM (SVN53-67/M57-KLH). Methods: A single-arm, multi-center phase II trial was conducted in 63 evaluable patients with nGBM with HLA-A*02, -A*03, -A*11 and -A*24 haplotypes and Karnofsky performance status ≥70. Patients (Pts) underwent craniotomy with near-total resection ( < 1 cm3 residual contrast enhancement), followed by chemoradiation (Stupp) were eligible. Pts received 4 priming doses of SurVaxM (500 mcg) with Montanide and sargramostim (100 mcg) every 2 weeks, followed by adjuvant TMZ and maintenance SurVaxM every 12 weeks until progression. Immunogenicity of SurVaxM was assessed using expansion of survivin-specific CD8+ T-cells (dextramers) and survivin antibody (IgG) levels. Results: Interim analysis of t...