Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer

作者：Johan Vansteenkiste, I. Demedts, Kristof Cuppens, Elvire Pons‐Tostivint, Els Wauters, Frank J. Borm, A. Sibille, Benoît Colinet, M. Pérol, Willemijn S.M.E. Theelen, B. Biesma, C. Van De Kerkhove, E.L. Buchmeier, F.C. Althoff, S. Derijcke, Denis Moro‐Sibilot, Karine Laulagnier, E. Halioua, Liran Levy, Michèle Genin, Sébastien Michel, C. Dedry, Camille Duchayne, M. Collodoro, Florence Renard, Stefanie Adriaenssens, Béatrice De Vos, F. Cantero, Joël Plumas, M. Skrzypski · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105844 · 被引用次数：5 · 研究领域：Immunotherapy and Immune Responses、Cancer Immunotherapy and Biomarkers、vaccines and immunoinformatics approaches

While immune checkpoint inhibitors have revolutionized the treatment of non-small-cell lung cancer (NSCLC), many patients still suffer from either primary or acquired treatment resistance. Stimulation of antitumor cellular immunity with a therapeutic cancer vaccine in combination with anti-programmed cell death (ligand) protein 1 [PD-(L)1] may improve outcome. PDC ∗ lung01 is a cancer vaccine made of irradiated plasmacytoid dendritic cells loaded with six NSCLC tumor antigens (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, and Survivin), and available as a ready-to-use product. This open-label, dose-escalation, multicenter, phase I/II study assessed the safety profile, clinical activity, and immunogenicity of PDC ∗ lung01 at low or high doses, either as a single agent in resected NSCLC (cohorts A) or with anti-PD-1 in metastatic NSCLC with PD-L1 ≥ 50% (cohorts B). The primary objective was vaccine-related dose-limiting toxicities (DLTs). Secondary objectives included safety profile, T-cell response against vaccine antigens in all cohorts, and clinical activity in cohort B2 (high-dose PDC∗lung01 with anti-PD-1): objective response rate (ORR) and 9-month progression-free survival (9mPFS). Median follow-up was 20 months [95% confidence interval (CI) 14-26 months] in all enrolled patients ( N = 73). Most adverse events were mild to moderate; only one patient (2%) in cohort B2 reported a related DLT. In the combination of PDC∗lung01 (high-dose) with anti-PD-1 ( N = 45), the confi...