119MO Phase I/II trial evaluating the innovative therapeutic cancer vaccine PDC*lung01 in combination with anti-PD-1 in patients (pts) with untreated stage IV non-small cell lung cancer
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: Background: PDC*lung01 (IMP) is an innovative therapeutic cancer vaccine, synergistic with anti-PD-1, based on an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01-restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A), able to prime and expand antigen-specific CD8+ T cells in vitro and in vivo.Methods: This phase I/II study (NCT03970746) enrolled HLA-A*02 positive NSCLC pts in 4 cohorts: 2 cohorts with IMP in resected stage II/IIIA in adjuvant setting following SoC (low A1 and high dose A2) and 2 cohorts with IMP plus pembrolizumab 200 mg q3w in untreated stage IV NSCLC with PD-L150% and no targetable driver mutation (low B1 and high-dose B2).IMP was administered by SC and IV routes weekly for 6 consecutive doses.We report cohort B2 efficacy results of the 42 evaluable pts from the designed per protocol population: objective response rate (ORR) and progression-free survival (PFS).
Source: Immuno-Oncology Technology
Institutions: Universitair Ziekenhuis Leuven, Jessa Hospital, AZ Delta, Leiden University Medical Center, Jeroen Bosch Ziekenhuis, Centre Léon Bérard, The Netherlands Cancer Institute, KU Leuven, Grand Charleroi Hospital, Kliniken der Stadt Köln, Goethe University Frankfurt, University Hospital Frankfurt, Centre Hospitalier Universitaire de Nantes, AZ Groeninge, Centre Hospitalier Universitaire de Grenoble, Hôpital Albert Michallon, Centre Hospitalier Universitaire de Liège, Gdańsk Medical University
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,170
OpenAlex ID: W4405374368
