6PD - Phase I/II study of IMA950 peptide vaccine with Poly-ICLC in combination with standard therapy in newly diagnosed A2 glioblastoma: Preliminary results

Date 20 November 2015
Event ESMO Symposium on Immuno-Oncology 2015
Session Poster Discussion session
Topics Cancer Immunology and Immunotherapy
Central Nervous System Malignancies
Presenter Denis Migliorini
Citation Annals of Oncology (2015) 26 (suppl_8): 1-4. 10.1093/annonc/mdv513
Authors D. Migliorini, V. Dutoit, P.R. Walker, P. Dietrich
  • Dpt Des Spécialités De Médecine, Hopitaux Universitaires de Genève Unité de recherche clinique du centre d'Oncologie, 1211 Geneva - Geneva/CH

Abstract

Aim

Immunotherapy has proved to have solid ground in the field of gliomas, the identification of tumor associated peptides on glioblastoma cells has been the background work that led to a multipeptide vaccine of 9 HLA A2 restricted peptides.

Methods

Phase I/II trial, A2+ resected newly diagnosed GBM patients received standard chemoradiation with temozolomide, and 6 vaccinations (before) or 4 (after amendment) with PolyICLC once a week after radiation then 5 vaccinations once a month alternately with the 6 cycles of temozolomide. Primary endpoint was safety, second endpoint OS, PFS at 6, 9 months, and immunological endpoints.

Results

12 patients have been enrolled. The first 6 patients received 6 vaccinations in 4 weeks, then 5 vaccinations once a month, injected ID and the adjuvant IM in close vicinity, the injection site varied to stimulate multiple draining lymph nodes. Preliminary analysis did not show induction of specific CD4 or CD8 T cells, leading us to rethink the vaccination schedule. An amendment incorporated the following changes: decrease in the number of initial vaccinations, mixing vaccine and adjuvant before injection at one single site, two different injection routes for the remaining 10 patients: SC or IM. IMA-950 was well tolerated either before or after the amendment, the most common side effect was local inflammatory reaction at injection site. Some patients experienced cerebral edema, easily manageable with steroids. Accrual started on September 2013, among the 6 first patients, 2 showed disease progression, the median OS was 17.5 months. 3 Patients under the amended protocol are still under therapy and 3 others finished the protocol and are being followed (no tumor recurrence). Preliminary analysis of vaccine-induced T cell responses in two of the 6 patients treated with the amended protocol showed induction of both peptide-specific CD4 and CD8 T cells, suggesting that changes made in the protocol might lead to better immunization.

Conclusions

IMA-950 is safe, and preliminary median OS seems to be improved. Definitive trial results will provide us important hindsight in defining the most powerful vaccination formulation and schedules.

Clinical trial identification

NCT01920191

Disclosure

All authors have declared no conflicts of interest.