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000303378 1001_ $$aEichhorn, Martin E$$b0
000303378 245__ $$aNeoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: results of the NEOMUN trial.
000303378 260__ $$aLondon$$bBioMed Central$$c2025
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000303378 520__ $$aThe phase II NEOMUN trial was conducted to investigate the therapeutic effect of preoperative programmed death receptor-1 inhibitor pembrolizumab for treating non-small cell lung cancer (NSCLC). Herein, we report the final efficacy, safety, and long-term survival results.Patients with resectable stage II/IIIA NSCLC were included. Two cycles of pembrolizumab (200 mg intravenously once every 3 weeks) were administered before surgery. The primary objectives were to assess the feasibility and safety of neoadjuvant treatment and evaluate antitumor activity. We analyzed the clinical parameters and pathologic, radiological, and metabolic tumor response data.29 patients with NSCLC were enrolled. NSCLC histology revealed adenocarcinoma and squamous cell carcinoma in 24 and in 5 patients, respectively. 93.1% of patients were treated with two therapy cycles. 73 adverse events were reported, of which 18 were treatment-related. Complete tumor resection rate was 100%. Major (≤10% vital tumor cells) and complete pathologic response rates were 24.1% and 13.8%, respectively. Tumor response increased with higher programmed death-ligand 1 tumor proportion scores (TPS) and high pretherapeutic tumor mutational burden (≥10 mut./Mb). The metabolic response, quantified non-invasively using positron emission tomography/CT, predicted the pathologic tumor response. The disease-free survival was 75.9% at 24 and 36 months, and the overall survival was 82.7% at 24 and 36 months.Neoadjuvant immunotherapy with pembrolizumab appears safe and feasible and is associated with a remarkable major pathologic response rate. Preoperative TPS, change in maximal standardized uptake value during the induction phase, and high mutational burden might be suitable clinical parameters for predicting pathologic response in surgical candidates.NCT0319746.
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000303378 650_7 $$2Other$$aBiomarker
000303378 650_7 $$2Other$$aImmune Checkpoint Inhibitor
000303378 650_7 $$2Other$$aMajor pathologic response - MPR
000303378 650_7 $$2Other$$aNeoadjuvant
000303378 650_7 $$2Other$$aNon-Small Cell Lung Cancer
000303378 650_7 $$0DPT0O3T46P$$2NLM Chemicals$$apembrolizumab
000303378 650_7 $$2NLM Chemicals$$aAntibodies, Monoclonal, Humanized
000303378 650_7 $$2NLM Chemicals$$aProgrammed Cell Death 1 Receptor
000303378 650_7 $$2NLM Chemicals$$aImmune Checkpoint Inhibitors
000303378 650_7 $$2NLM Chemicals$$aAntineoplastic Agents, Immunological
000303378 650_2 $$2MeSH$$aHumans
000303378 650_2 $$2MeSH$$aAntibodies, Monoclonal, Humanized: therapeutic use
000303378 650_2 $$2MeSH$$aAntibodies, Monoclonal, Humanized: pharmacology
000303378 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: drug therapy
000303378 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: pathology
000303378 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: mortality
000303378 650_2 $$2MeSH$$aMale
000303378 650_2 $$2MeSH$$aFemale
000303378 650_2 $$2MeSH$$aMiddle Aged
000303378 650_2 $$2MeSH$$aAged
000303378 650_2 $$2MeSH$$aLung Neoplasms: drug therapy
000303378 650_2 $$2MeSH$$aLung Neoplasms: pathology
000303378 650_2 $$2MeSH$$aNeoadjuvant Therapy: methods
000303378 650_2 $$2MeSH$$aAdult
000303378 650_2 $$2MeSH$$aProgrammed Cell Death 1 Receptor: antagonists & inhibitors
000303378 650_2 $$2MeSH$$aImmunotherapy: methods
000303378 650_2 $$2MeSH$$aImmune Checkpoint Inhibitors: therapeutic use
000303378 650_2 $$2MeSH$$aImmune Checkpoint Inhibitors: pharmacology
000303378 650_2 $$2MeSH$$aAntineoplastic Agents, Immunological: therapeutic use
000303378 650_2 $$2MeSH$$aAntineoplastic Agents, Immunological: pharmacology
000303378 7001_ $$aNiedermaier, Benedikt$$b1
000303378 7001_ $$0P:(DE-He78)8dde8d3920dc06c59314abdb4ac7d2e8$$aCharoentong, Pornpimol$$b2$$udkfz
000303378 7001_ $$aKlotz, Laura V$$b3
000303378 7001_ $$aBaum, Philip$$b4
000303378 7001_ $$aGriffo, Raffaella$$b5
000303378 7001_ $$aAllgäuer, Michael$$b6
000303378 7001_ $$aStenzinger, Albrecht$$b7
000303378 7001_ $$aBischoff, Helge$$b8
000303378 7001_ $$aSchneider, Marc A$$b9
000303378 7001_ $$aChristopoulos, Petros$$b10
000303378 7001_ $$aHaberkorn, Uwe$$b11
000303378 7001_ $$aHeußel, Claus-Peter$$b12
000303378 7001_ $$00000-0003-1538-2091$$aSavai, Rajkumar$$b13
000303378 7001_ $$0P:(DE-He78)72e6f8462f1b903eef99df71d9d8817b$$aRoberti, Maria Paula$$b14$$udkfz
000303378 7001_ $$0P:(DE-HGF)0$$aZoernig, Inka$$b15
000303378 7001_ $$0P:(DE-He78)ed0321409c9cde20b380ae663dbcefd1$$aJäger, Dirk$$b16$$udkfz
000303378 7001_ $$aHerth, Felix$$b17
000303378 7001_ $$aThomas, Michael$$b18
000303378 7001_ $$aWinter, Hauke$$b19
000303378 7001_ $$aEichhorn, Florian$$b20
000303378 773__ $$0PERI:(DE-600)2719863-7$$a10.1136/jitc-2025-011874$$gVol. 13, no. 8, p. e011874 -$$n8$$pe011874$$tJournal for ImmunoTherapy of Cancer$$v13$$x2051-1426$$y2025
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