CTIM-26. PHASE II TRIAL OF SURVAXM PLUS TEMOZOLOMIDE FOR NEWLY DIAGNOSED GLIOBLASTOMA

Abstract BACKGROUND Newly diagnosed glioblastoma (nGBM) has dismal outcomes with survival of 15-18 months. Tumor associated “survivin” is expressed in > 95% nGBM and targetable by SurVaxM immunotherapy. METHODS patients (pts) were enrolled this Phase 2 study, age ≥ 18, KPS 70, IHC confirmed surviving-expression, expression HLA-A*02, A*03, A*11 or A*24 MHC-I alleles residual contrast enhancement ≤1 cm3 MRI. Pts treated standard TMZ chemoradiation followed initiation 4 priming doses (500 mcg emulsion Montanide ISA 51, every weeks) 100 sargramostim. Maintenance SurVaxM-Montanide plus sargramostim given 12 weeks Adjuvant for at least 6 cycles. The primary endpoint was 70% progression free (PFS) mos. Primary analyses median PFS (mPFS) overall (OS) measured from the first immunization. Safety, tolerability, immune responsiveness also determined. RESULTS 63 pts (38 males), age, 60 years 5 sites. well tolerated, no serious adverse events. A strong positive correlation, accounting censoring, observed between OS all (r = 0.79; CI (0.66,0.87)). immunogenic produced survivin-specific CD8+ T-cells antibody (IgG) titers both methylated unmethylated MGMT pts. Both groups showed clinical benefit 11.4 months whole group, 7.0 17.9 group. 25.9 16.5 41.4 CONCLUSIONS appeared to be safe well-tolerated nGBM. effective stimulating responses met. represents a promising therapy nGBM, randomized trial ongoing. Clinical information: NCT02455557.