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@ARTICLE{Eichhorn:303378,
author = {M. E. Eichhorn and B. Niedermaier and P. Charoentong$^*$
and L. V. Klotz and P. Baum and R. Griffo and M. Allgäuer
and A. Stenzinger and H. Bischoff and M. A. Schneider and P.
Christopoulos and U. Haberkorn and C.-P. Heußel and R.
Savai and M. P. Roberti$^*$ and I. Zoernig$^*$ and D.
Jäger$^*$ and F. Herth and M. Thomas and H. Winter and F.
Eichhorn},
title = {{N}eoadjuvant anti-programmed death-1 immunotherapy by
pembrolizumab in resectable non-small cell lung cancer:
results of the {NEOMUN} trial.},
journal = {Journal for ImmunoTherapy of Cancer},
volume = {13},
number = {8},
issn = {2051-1426},
address = {London},
publisher = {BioMed Central},
reportid = {DKFZ-2025-01627},
pages = {e011874},
year = {2025},
abstract = {The phase II NEOMUN trial was conducted to investigate the
therapeutic effect of preoperative programmed death
receptor-1 inhibitor pembrolizumab for treating non-small
cell lung cancer (NSCLC). Herein, we report the final
efficacy, safety, and long-term survival results.Patients
with resectable stage II/IIIA NSCLC were included. Two
cycles of pembrolizumab (200 mg intravenously once every 3
weeks) were administered before surgery. The primary
objectives were to assess the feasibility and safety of
neoadjuvant treatment and evaluate antitumor activity. We
analyzed the clinical parameters and pathologic,
radiological, and metabolic tumor response data.29 patients
with NSCLC were enrolled. NSCLC histology revealed
adenocarcinoma and squamous cell carcinoma in 24 and in 5
patients, respectively. $93.1\%$ of patients were treated
with two therapy cycles. 73 adverse events were reported, of
which 18 were treatment-related. Complete tumor resection
rate was $100\%.$ Major $(≤10\%$ vital tumor cells) and
complete pathologic response rates were $24.1\%$ and
$13.8\%,$ respectively. Tumor response increased with higher
programmed death-ligand 1 tumor proportion scores (TPS) and
high pretherapeutic tumor mutational burden (≥10 mut./Mb).
The metabolic response, quantified non-invasively using
positron emission tomography/CT, predicted the pathologic
tumor response. The disease-free survival was $75.9\%$ at 24
and 36 months, and the overall survival was $82.7\%$ at 24
and 36 months.Neoadjuvant immunotherapy with pembrolizumab
appears safe and feasible and is associated with a
remarkable major pathologic response rate. Preoperative TPS,
change in maximal standardized uptake value during the
induction phase, and high mutational burden might be
suitable clinical parameters for predicting pathologic
response in surgical candidates.NCT0319746.},
keywords = {Humans / Antibodies, Monoclonal, Humanized: therapeutic use
/ Antibodies, Monoclonal, Humanized: pharmacology /
Carcinoma, Non-Small-Cell Lung: drug therapy / Carcinoma,
Non-Small-Cell Lung: pathology / Carcinoma, Non-Small-Cell
Lung: mortality / Male / Female / Middle Aged / Aged / Lung
Neoplasms: drug therapy / Lung Neoplasms: pathology /
Neoadjuvant Therapy: methods / Adult / Programmed Cell Death
1 Receptor: antagonists $\&$ inhibitors / Immunotherapy:
methods / Immune Checkpoint Inhibitors: therapeutic use /
Immune Checkpoint Inhibitors: pharmacology / Antineoplastic
Agents, Immunological: therapeutic use / Antineoplastic
Agents, Immunological: pharmacology / Biomarker (Other) /
Immune Checkpoint Inhibitor (Other) / Major pathologic
response - MPR (Other) / Neoadjuvant (Other) / Non-Small
Cell Lung Cancer (Other) / pembrolizumab (NLM Chemicals) /
Antibodies, Monoclonal, Humanized (NLM Chemicals) /
Programmed Cell Death 1 Receptor (NLM Chemicals) / Immune
Checkpoint Inhibitors (NLM Chemicals) / Antineoplastic
Agents, Immunological (NLM Chemicals)},
cin = {D120},
ddc = {610},
cid = {I:(DE-He78)D120-20160331},
pnm = {314 - Immunologie und Krebs (POF4-314)},
pid = {G:(DE-HGF)POF4-314},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:40759442},
doi = {10.1136/jitc-2025-011874},
url = {https://inrepo02.dkfz.de/record/303378},
}