P.020 Avelumab in newly diagnosed glioblastoma multiforme-the SEJ study

Abstract

Background: Glioblastoma Multiforme (GBM) has well documented systemic and local immunosuppressive mechanisms to escape immune surveillance and grow. GBM tumor cells as well as the microglia within it have a high incidence of PD-L1 surface expression which makes it more susceptible to anti-PD-L1 antagonism and ADCC through avelumab therapy. Methods: This is a single center, phase 2, open label, add-on, single dose study of 156 weeks duration in patients receiving standard therapy for newly diagnosed GBM. In total 30 patients will be entered into the study within 3 weeks of finishing their last day of combined radiotherapy/temozolomide. The following are the results of the first interim analysis completed when the first eight patients completed 52 weeks or an end of study visit. Results: 24 patients have so far started therapy. There as been no unexpected treatment emergent adverse event (TEAE). Two patients transiently withheld therapy because of immune related TEAE’s and none permanently. The objective response rate at week 52 for the first eight patients was 50% with 2 (25%) having a complete response and 1 (12.5%) a partial response. Conclusions: These preliminary results suggest that the addition of avelumab to standard therapy in patients with GBM is safe. Efficacy trends look promising.