The following is a summary of “Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma,” published in the March 2023 issue of Oncology by Ahluwalia, et al.

For a study, researchers sought to investigate the effectiveness and safety of SurVaxM, a peptide vaccine conjugate combined with temozolomide (TMZ) chemotherapy, for newly diagnosed glioblastoma (nGBM). The peptide vaccine SurVaxM, whose target protein survivin is widely expressed by glioblastoma cells, has been demonstrated to stimulate the immune system against it.

The research team conducted a phase IIa, open-label, multicenter trial involving 64 patients with resected nGBM. Patients received SurVaxM (500 μg once every 2 weeks) plus adjuvant TMZ following surgery and chemoradiation. Immunologic responses to SurVaxM were assessed, and progression-free survival (PFS) and overall survival (OS) were reported.

Results showed that SurVaxM plus TMZ was well tolerated with no serious adverse events. Of the 63 patients evaluated for the outcome, 60 (95.2%) remained progression-free 6 months after diagnosis, which was the prespecified primary endpoint. The median PFS was 11.4 months, and the median OS was 25.9 months, measured from the first dose of SurVaxM. SurVaxM produced survivin-specific CD8+ T cells and antibody/immunoglobulin G titers. Apparent clinical benefit of SurVaxM was observed in both methylated and unmethylated patients. The study concluded that SurVaxM appeared safe and well tolerated, and the combination with TMZ represents a promising therapy for nGBM. 

The results suggested that PFS may be an acceptable surrogate for OS in patients with nGBM treated with this combination therapy. A large randomized clinical trial of SurVaxM for nGBM was underway.