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

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).