{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:20:07Z","timestamp":1791908407518,"version":"4.3.4"},"reference-count":35,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T00:00:00Z","timestamp":1738627200000},"content-version":"unspecified","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2024,12,29]]},"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pembrolizumab monotherapy is an established front-line treatment for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS)\u226550%. However, real-world data on its long-term efficacy remains sparse.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study assessed 5-year outcomes of first-line pembrolizumab monotherapy in a large, multicenter, real-world cohort of patients with advanced NSCLC and PD-L1 TPS\u226550%, referred to as Pembro-real 5Y. Individual patient-level data (IPD) from the experimental arm of the KEYNOTE-024 trial were extracted (KN024 IPD cohort) to compare the long-term outcomes between the two cohorts. To further assess the reproducibility of clinical trial results, we reconstructed the \u201cKN024 look-alike\u201d cohort by excluding patients with an Eastern Cooperative Oncology Group-performance status (ECOG-PS)\u22652, those requiring corticosteroids with doses \u226510\u2009mg of prednisolone\/equivalent, patients with positive\/unknown epidermal growth factor receptor\/anaplastic lymphoma kinase genotype, and those with pre-existing autoimmune disease. We additionally provided a hierarchical organization of determinants of long-term benefit through a conditional inference tree analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study included 1050 patients from 61 institutions across 14 countries, with a median follow-up of 70.3 months. The 5-year survival rate was 26.9% (95% CI: 23.8% to 30.2%), and median OS was 21.8 months (95%\u2009CI: 19.1 to 25.7), while 32 (3.0%) patients who achieved a complete response remained progression-free at the data cut-off. The KN024 look-alike cohort had a 5-year survival rate of 29.3% (95% CI: 25.5% to 33.6%) and a median OS of 27.5 months (95%\u2009CI: 22.8 to 31.3). Neither the overall study population nor the KN024 look-alike cohort exhibited significantly different OS compared with the KN024 IPD cohort. By the data cut-off, 1015 patients (96.7%) had permanently discontinued treatment: 659 (64.9%) due to progressive disease, 156 (15.4%) due to toxicity, 77 (7.6%) due to treatment completion, and 106 (10.4%) due to other reasons. Overall, 222 participants (21.1%) were treated for a minimum period of 24 months, among them the 5-year survival rates were: 31.7%, 72.7%, 78.6%, 84.2% for patients who discontinued treatment due to progressive disease, toxicity, treatment completion, and other reasons, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study provides valuable real-world evidence that confirms the long-term efficacy of pembrolizumab outside of clinical trials. Hierarchical organization indicates ECOG-PS, age and PD-L1-TPS as the most important predictors of 5-year survival, potentially informing clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2024-010674","type":"journal-article","created":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T12:50:36Z","timestamp":1738673436000},"page":"e010674","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["Determinants of 5-year survival in patients with advanced NSCLC with PD-L1\u226550% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1209-5735","authenticated-orcid":false,"given":"Alessio","family":"Cortellini","sequence":"first","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy"},{"name":"Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, London, UK"},{"name":"Department of Medicine and Surgery, Universit\u00e0 Campus Bio-Medico di Roma, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo","family":"Brunetti","sequence":"additional","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy"},{"name":"Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, London, UK"},{"name":"Department of Medicine and Surgery, Universit\u00e0 Campus Bio-Medico di Roma, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppina Rita","family":"Di Fazio","sequence":"additional","affiliation":[{"name":"Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy"},{"name":"Department of Medicine and Surgery, Universit\u00e0 Campus Bio-Medico di Roma, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edoardo","family":"Garbo","sequence":"additional","affiliation":[{"name":"Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3529-0103","authenticated-orcid":false,"given":"David J","family":"Pinato","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, London, UK"},{"name":"Translational Medicine Department, University of Eastern Piedmont, AOU Maggiore della Carit\u00e0 Hospital, Novara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jarushka","family":"Naidoo","sequence":"additional","affiliation":[{"name":"Department of Oncology, Beaumont Hospital, Beaumont RCSI Cancer Centre, Dublin, Ireland"},{"name":"RCSI University of Health Sciences, Dublin, Ireland"},{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Artur","family":"Katz","sequence":"additional","affiliation":[{"name":"Oncology Center, Hospital S\u00edrio-Liban\u00eas, Sao Paulo, Sao Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Loza","sequence":"additional","affiliation":[{"name":"Department of Medicine Stanford Cancer Institute, Division of Oncology Stanford University, Stanford, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel W","family":"Neal","sequence":"additional","affiliation":[{"name":"Department of Medicine Stanford Cancer Institute, Division of Oncology Stanford University, Stanford, California, 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