11PD - IMA950 multipeptide vaccine adjuvanted with Poly-ICLC in combination with standard therapy in newly diagnosed HLA-A2 glioblastoma patients (11PD)

Date 09 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Poster Discussion session
Topics Complications of Treatment
Cancer in Pregnancy
Cancer in Special Situations
Presenter Valérie Dutoit
Citation Annals of Oncology (2017) 28 (suppl_11): xi3-xi5. 10.1093/annonc/mdx710
Authors V. Dutoit1, D. Migliorini1, A. Patrikidou1, A. Mayer-Mokler2, N. Hilf2, P.R. Walker1, P. Dietrich1
  • 1Oncology, Geneva University Hospital, 1211 - Geneva/CH
  • 2Clinical Program, immatics biotechnologies, 72001 - Tuebingen/DE

Abstract

Background

Immunotherapy is a promising alternative strategy for patients with glioblastoma (GBM). Here, we conducted a phase I/II trial to address the safety and immunogenicity of a multipeptide therapeutic vaccine (IMA950) adjuvanted with Poly-ICLC in patients with newly diagnosed GBM.

Methods

Sixteen HLA-A2+ GBM patients were included. Patients received the standard of care treatment including surgery, 6-week chemo-radiation therapy, and 6-12 adjuvant cycles of temozolomide. IMA950 (composed of nine glioma-associated CD8 peptides and two tumor-associated CD4 peptides) was injected starting one week after the end of chemo-radiation therapy. Primary endpoints were safety and immunogenicity; secondary endpoints were OS and PFS at six and nine months.

Results

In the first six patients, peptides were injected intradermally (i.d.) and Poly-ICLC intramuscularly (i.m.). Low levels of vaccine-induced CD8 T cell responses were detected following this vaccination schedule, leading us to modify the vaccination protocol. In the modified schedule, peptides and adjuvant were mixed before injection, which was given i.m. for six patients and subcutaneously (s.c.) for seven patients, in an effort to determine the optimal injection route. Clinically, the IMA950/Poly-ICLC vaccine was well tolerated, the most common side effect being local inflammation at the injection site. A few patients experienced cerebral edema, which was manageable with steroids. Analysis of vaccine-induced T cell responses revealed that 63% of patients responded to one CD8 peptide and 37% responded to two or more CD8 peptides. Modifying the vaccination protocol resulted in detection of multipeptide responses in 46% of patients, as compared with 17% in the initial protocol. Vaccine-induced CD4 T cell responses were detected in the majority of patients and were of Th1 phenotype. Median OS was 21.2 months.

Conclusions

Overall, the IMA950/Poly-ICLC vaccine is safe, immunogenic and preliminary median OS is encouraging. Definitive clinical results and correlation with immunological data will indicate the most efficacious route of vaccination for use in further trials in glioma patients.

Clinical trial identification

NCT01920191

Legal entity responsible for the study

Pierre-Yves Dietrich

Funding

The Gateway for cancer research, Rising Tides (USA)

Disclosure

All authors have declared no conflicts of interest.