PMID- 37699785 OWN - NLM STAT- MEDLINE DCOM- 20231107 LR - 20231213 IS - 1759-7714 (Electronic) IS - 1759-7706 (Print) IS - 1759-7706 (Linking) VI - 14 IP - 31 DP - 2023 Nov TI - Nivolumab as maintenance therapy following platinum-based chemotherapy in EGFR-mutant lung cancer patients after tyrosine kinase inhibitor failure: A single-arm, open-label, phase 2 trial. PG - 3080-3088 LID - 10.1111/1759-7714.15083 [doi] AB - BACKGROUND: As the outcome of immunotherapy can be improved when concurrently or sequentially combined with cytotoxic chemotherapy or radiotherapy, we investigated the efficacy of immunotherapy maintenance following platinum-based chemotherapy in epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) after EGFR-tyrosine kinase inhibitor (EGFR-TKI) failure. METHODS: In this prospective, open-label, single arm phase 2 trial, we enrolled patients aged 18 years or older with EGFR-mutant NSCLC, which progressed after first- or second-line EGFR-TKI. Patients received platinum-based chemotherapy followed by nivolumab maintenance therapy. They were intravenously administered 240 mg of nivolumab every 2 weeks for 3 months followed by 480 mg every 4 weeks until disease progression or unacceptable toxic effects occurred. The primary endpoint was progression-free survival (PFS). Secondary outcomes were overall survival (OS) and incidence of grade 3-4 treatment-related adverse events (AEs). RESULTS: We enrolled 26 patients between May 2020 and July 2021. The median PFS was 1.7 months (95% CI: 0.401-2.999 months). The median OS was 21.4 months (95% CI: 18.790-24.010 months) with 6- and 12-month OS rates of 96.2% and 76.9%, respectively. The objective response rate was 7.7% (2/26) and disease control rate, 11.5% (3/26). The tumor mutational burden by next-generation sequencing in blood was not related to the treatment outcomes. Grade 3-4 treatment-related AEs occurred in four (15.4%) patients; the most frequent AE was increased alanine aminotransferase (7.7%). CONCLUSION: Nivolumab maintenance following platinum-based chemotherapy did not show clinical benefits after EGFR-TKI failure in patients with EGFR-mutant NSCLC. CI - (c) 2023 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd. FAU - Kim, Jiwon AU - Kim J AUID- ORCID: 0000-0002-7193-210X AD - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. FAU - Choi, Chang-Min AU - Choi CM AUID- ORCID: 0000-0002-2881-4669 AD - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. AD - Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. FAU - Ji, Wonjun AU - Ji W AUID- ORCID: 0000-0001-7164-2770 AD - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. FAU - Lee, Jae Cheol AU - Lee JC AUID- ORCID: 0000-0001-5963-0259 AD - Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. AD - Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230912 PL - Singapore TA - Thorac Cancer JT - Thoracic cancer JID - 101531441 RN - 31YO63LBSN (Nivolumab) RN - 0 (Tyrosine Kinase Inhibitors) RN - EC 2.7.10.1 (ErbB Receptors) RN - 49DFR088MY (Platinum) RN - 0 (Protein Kinase Inhibitors) RN - EC 2.7.10.1 (EGFR protein, human) SB - IM MH - Humans MH - *Lung Neoplasms/drug therapy/genetics MH - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics MH - Nivolumab/pharmacology/therapeutic use MH - Tyrosine Kinase Inhibitors MH - Prospective Studies MH - ErbB Receptors/genetics MH - Platinum/pharmacology/therapeutic use MH - Mutation MH - Antineoplastic Combined Chemotherapy Protocols MH - Protein Kinase Inhibitors/pharmacology/therapeutic use PMC - PMC10626224 OTO - NOTNLM OT - adverse events OT - immunotherapy OT - non-small cell lung cancer OT - outcomes OT - tumor mutation burden COIS- The authors have no conflicts of interest to declare. The funders had no role in the design of this study, data collection, data analyses, data interpretation, writing of the manuscript, or the decision to publish the results. EDAT- 2023/09/13 00:42 MHDA- 2023/11/07 06:45 PMCR- 2023/09/12 CRDT- 2023/09/12 21:52 PHST- 2023/08/07 00:00 [revised] PHST- 2023/04/13 00:00 [received] PHST- 2023/08/08 00:00 [accepted] PHST- 2023/11/07 06:45 [medline] PHST- 2023/09/13 00:42 [pubmed] PHST- 2023/09/12 21:52 [entrez] PHST- 2023/09/12 00:00 [pmc-release] AID - TCA15083 [pii] AID - 10.1111/1759-7714.15083 [doi] PST - ppublish SO - Thorac Cancer. 2023 Nov;14(31):3080-3088. doi: 10.1111/1759-7714.15083. Epub 2023 Sep 12.