Abstract 4555
Background
DPX-Survivac is a novel T cell activating therapy that has been shown to elicit a strong and prolonged immune response against tumors expressing survivin and correlated with clinical benefits in ovarian cancer. The survivin specific T cells activated by DPX-Survivac, in combination with CPA, are infiltrating the tumors and lead to clinical responses. In preclinical studies, treatment with DPX-Survivac has shown to increase the PD-L1 and PD-1 expression. Pembrolizumab is a potent humanized IgG4 monoclonal antibody with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and 2 (PD-L2). This study investigates if a synergistic effect leading to enhanced clinical benefits for the subjects can be achieved with the combination of the checkpoint inhibitor pembrolizumab and the T cell activation therapy, DPX-Survivac, with CPA in subjects with solid tumors.
Methods
This basket trial recruits in ovarian cancer, HCC, NSCLC, bladder cancer and MSI-H tumors. Subjects from all cohorts receive DPX-Survivac and pembrolizumab with intermittent low dose CPA. Subjects are treated for up to 35 cycles of pembrolizumab or confirmed progression, whichever occurs first. The primary objectives are to determine the objective response rate (ORR) by RECIST 1.1 and the safety profile. Secondary objectives include duration of response, disease control rate, progression free survival (PFS), and overall survival (OS). Exploratory analyses will look at the T cell responses and infiltration of the tumor along with biomarker analysis.
Results
The lead-in safety assessment is complete with no modification to the dosing regimen. Preliminary data from the HCC, NSCLC, bladder cancer, and MSI-H cohorts are reported including ORR and safety as well as T cell responses and T cell infiltration.
Conclusions
No safety concerns have been observed with the combination therapy which is showing early signs of clinical efficacy. Enrollment is expected to continue to Stage 2 of the Simon 2 stage design.
Clinical trial identification
NCT03836352.
Editorial acknowledgement
Legal entity responsible for the study
IMV Inc.
Funding
IMV Inc.
Disclosure
L.D. MacDonald: Shareholder / Stockholder / Stock options, Full / Part-time employment: IMV Inc. S. Fiset: Shareholder / Stockholder / Stock options, Full / Part-time employment: IMV Inc. Y.M. Bramhecha: Shareholder / Stockholder / Stock options, Full / Part-time employment: IMV Inc. M. Chaney: Full / Part-time employment: Merck & Co. G.N. Rosu: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: IMV Inc. All other authors have declared no conflicts of interest.
Resources from the same session
3186 - The landscape of immuno-oncology clinical trials in China
Presenter: Dawei Wu
Session: Poster Display session 3
Resources:
Abstract
3468 - Clinical Significance of Immune-related Creatine Phosphokinase Increase Associated with Anti PD1/PD-L1 immunotherapies.
Presenter: Samia Hajem
Session: Poster Display session 3
Resources:
Abstract
3836 - Thyroid toxicity and anti-thyroid antibodies as predictive markers for patients treated with anti-PD1 checkpoint therapy
Presenter: Wim Meer
Session: Poster Display session 3
Resources:
Abstract
1343 - Treatment-related adverse events and tolerability in patients with advanced renal cell carcinoma treated with first-line combination therapy with checkpoint inhibitors
Presenter: Thura Win Htut
Session: Poster Display session 3
Resources:
Abstract
5783 - Immune-related adverse events (irAEs) with single-agent PD-1 vs PD-L1 inhibitors: a meta-analysis of 8,730 patients from clinical trials
Presenter: Guru Sonpavde
Session: Poster Display session 3
Resources:
Abstract
5422 - EULAR recommendations for the diagnosis and the management of rheumatic immune-related adverse events due to cancer immunotherapy
Presenter: Marie Kostine
Session: Poster Display session 3
Resources:
Abstract
1202 - Radiographic characteristics and poor prognostic factors of interstitial lung disease (ILD) in nivolumab-treated patients with non-small cell lung cancer (NSCLC)
Presenter: Shinichi Sasaki
Session: Poster Display session 3
Resources:
Abstract
2749 - Use of Checkpoint Inhibitors (CPI) in Allogeneic Stem Cell Transplant Recipients: An Institutional Experience and A Systemic Review of the Literature
Presenter: Chantal Saberian
Session: Poster Display session 3
Resources:
Abstract
3256 - Deep Learning Radiomics distinguishes intrapulmonary Disease from Metastases in Immunotherapy-treated Melanoma Patients
Presenter: Thi Dan Linh Nguyen-Kim
Session: Poster Display session 3
Resources:
Abstract
5031 - Sarcoidosis-Like Reaction Mimics Progression in patients treated with immune checkpoint inhibitors
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract