Reference Detail

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abstract

PMID

Authors

Willemijn Theelen; Maurice Perol; Kristof Cuppens; Ingel Demedts; Frank Borm; Bonne Biesma; Els Wauters; Benoit Colinet; Eva-Lotte Buchmeier; Friederike Althoff; Elvire Pons-Tostivint; Charlotte Van de Kerkhove; Denis Moro-Sibilot; Anne Sibille; Sofie Derijcke; Marcin Skrzypski; Joel Plumas; Beatrice De Vos; Channa Debruyne; Frederique Cantero; Stefanie Adriaenssens; Florence Renard; Johan Vansteenkiste

Title

Abstract CT021: Preliminary clinical results of a therapeutic cancer vaccine PDC*lung01 in combination with anti-PD-1 in patients (pts) with stage IV NSCLC

Journal	Vol	Issue	Date	Pages	Journal Short Title
Cancer Res	84	7_supplement	2024

URL

https://aacrjournals.org/cancerres/article/84/7_Supplement/CT021/742272/Abstract-CT021-Preliminary-clinical-results-of-a

Abstract Text

Background PDC*lung01 (IMP) is a therapeutic cancer vaccine 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 peptide-specific CD8+ T cells in vitro and in vivo, and is synergistic with anti-PD-1. Methods In this phase I/II study, HLA-A*02 positive NSCLC pts were enrolled in 4 cohorts: resected stage II/IIIA in adjuvant setting treated with low dose (A1) or high dose (A2) of IMP following SOC; or untreated stage IV NSCLC with measurable disease, PD-L1≥50% and no targetable driver mutation, treated with low dose (B1) or high dose (B2) of IMP in combination to pembrolizumab 200mg q3w, continuously. IMP was simultaneously administered by SC and IV route weekly for 6 consecutive doses. Objective response rate (ORR) and progression-free survival (PFS) were assessed in cohort B2. We report herein preliminary efficacy results of the first 21 pts analysed when the 19th evaluable patient reached the 9-months PFS and the safety of 38 pts. Results Out of 21, 19 pts receiving at least 5 doses of IMP and having 1 post-baseline radiological evaluation were evaluated. The median follow-up was 12.5 months. The best objective response (BOR) included 12 PR (63.2%) and 7 SD (36.8%) with ORR of 63.2% (80% CI 45.9% - 78.2%) and a disease control rate (DCR) of 94.7%. The 9mPFS according to the Kaplan-Meier estimate was 52.1% (80% CI 36.5% - 65.56%). The mPFS was 10.9 months. The median duration of response was 9.49 months. An antigen-specific CD8+ T-cell response was induced against the lung antigens of the IMP in 68.4% of pts. Immune responses with remarkable expanded anti-tumor CD8+ T-cells were observed both in PR and SD. More immune response results will be available in the final analysis of the 45 pts of cohort B2. Treatment-related AEs (TRAEs) were mostly Grade 1-2. Only 1 severe TRAE occurred, a Grade 4 allergic infusion-related reaction, leading to IMP discontinuation. Thirteen pts experienced a serious AE, of which 3 were considered causally related to the IMP. Conclusions The BOR, ORR, DCR, PFS, duration of response and safety of PDC*lung01 in combination with anti-PD-1 showed encouraging signals suggesting that this combination may provide a clinical meaningful tumour response in stage IV NSCLC population with a mild safety profile. Interestingly, the immune response observed confirms the mechanism of action of the IMP in relation to clinical activity.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 over exp	lung non-small cell carcinoma	predicted - sensitive	PDC*lung01 + Pembrolizumab	Phase Ib/II	Actionable	In a Phase I/II trial, treatment with the combination of PDC*lung01 and Keytruda (pembrolizumab) demonstrated safety in non-small cell lung cancer patients with CD274 (PD-L1) expression (>=50%) and resulted in an objective response rate of 63.2% (12/19, all partial responses), a disease control rate of 94.7%, a median progression-free survival of 10.9 months, and a median duration of response of 9.49 months (Cancer Res (2024) 84 (7_Supplement): CT021; NCT03970746).	detail...