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
4900 - Molecular profiling and prognostic significance of TP53 mutations in Diffuse Large B Cell Lymphoma: identifying a high-risk subgroup
Presenter: Yuan-Kai Shi
Session: Poster Display session 3
Resources:
Abstract
3809 - Differential expression of various miRNAs in Pediatric Cytogenetically Normal Acute Myeloid Leukemia (CN-AML)
Presenter: Vikas Gaur
Session: Poster Display session 3
Resources:
Abstract
4750 - Circulating tumour cells in head and neck and non-small cell lung cancer
Presenter: Kenneth O'Byrne
Session: Poster Display session 3
Resources:
Abstract
3704 - OX40/OX40L protein expression in Non-small cell lung cancer and its role in clinical outcome and relationships with other immune biomarkers
Presenter: Xiaoshen Zhang
Session: Poster Display session 3
Resources:
Abstract
2235 - Effect of Serum Survivin on Survival among Non-Small Cell Lung Cancer Patients; NCI Experience
Presenter: Reham Rashed
Session: Poster Display session 3
Resources:
Abstract
2788 - Enhanced performance of prognostic estimation from TCGA RNAseq data using transfer learning.
Presenter: Helene Vanacker
Session: Poster Display session 3
Resources:
Abstract
4689 - Analysis of Circulating Tumor DNA for Early Relapse Detection in Stage III Colorectal Cancer After Adjuvant Chemotherapy
Presenter: Samuel Jacobs
Session: Poster Display session 3
Resources:
Abstract
1454 - Ascites-derived circulating microRNAs as potential diagnostic biomarkers of gastric cancer-associated malignant ascites
Presenter: Hye Sook Han
Session: Poster Display session 3
Resources:
Abstract
5574 - Results from TRIO030, a Pre-Surgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide
Presenter: Hsiao-Wang Chen
Session: Poster Display session 3
Resources:
Abstract
1787 - JMJD2A is a novel epigenetic factor of chemotherapeutic susceptibility in gastric cancer
Presenter: Yasushi Sato
Session: Poster Display session 3
Resources:
Abstract