| Title: |
Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials : results from the Pembro-real 5Y global registry |
| Authors: |
Cortellini, Alessio; Brunetti, Leonardo; Di Fazio, Giuseppina Rita; Garbo, Edoardo; Pinato, David J; Naidoo, Jarushka; Katz, Artur; Loza, Monica; Neal, Joel W; Genova, Carlo; Gettinger, Scott; Kim, So Yeon; Jayakrishnan, Ritujith; El Zarif, Talal; Russano, Marco; Pecci, Federica; Di Federico, Alessandro; Awad, Mark; Alessi, Joao V; Montrone, Michele; Owen, Dwight Hall; Signorelli, Diego; Fidler, Mary Jo; Li, Mingjia; Camerini, Andrea; De Giglio, Andrea; Young, Lauren; Vincenzi, Bruno; Metro, Giulio; Passiglia, Francesco; Yendamuri, Sai; Guida, Annalisa; Ghidini, Michele; Awosika, Nichola O; Napolitano, Andrea; Fulgenzi, Claudia A M; Grisanti, Salvatore; Grossi, Francesco; D'Incecco, Armida; Josephides, Eleni; Van Hemelrijck, Mieke; Russo, Alessandro; Gelibter, Alain; Spinelli, Gianpaolo; Verrico, Monica; Tomasik, Bartłomiej; Giusti, Raffaele; Newsom-Davis, Thomas; Bria, Emilio; Sebastian, Martin; Rost, Maximilian; Forster, Martin; Mukherjee, Uma; Landi, Lorenza; Mazzoni, Francesca; Aujayeb, Avinash; Dupont, Manuel; Curioni-Fontecedro, Alessandra; Chiari, Rita; Pantano, Francesco; Morabito, Alessandro; Leonetti, Alessandro; Friedlaender, Alex; Addeo, Alfredo; Zoratto, Federica; De Tursi, Michele; Cantini, Luca; Roca, Elisa; Mountzios, Giannis; Della Gravara, Luigi; Kalvapudi, Sukumar; Inno, Alessandro; Bironzo, Paolo; Di Marco Barros, Rafael; O'Reilly, David; Bell, Jack; Karapanagiotou, Eleni; Monnet, Isabelle; Baena, Javier; Macerelli, Marianna; Majem, Margarita; Agustoni, Francesco; Cortinovis, Diego Luigi; Tonini, Giuseppe; Minuti, Gabriele; Bennati, Chiara; Mezquita, Laura; Gorría, Teresa; Servetto, Alberto; Beninato, Teresa; Lo Russo, Giuseppe; Rogado, Jacobo; Moliner, Laura; Biello, Federica; Aboubakar Nana, Frank; Dingemans, Anne-Marie; Aerts, Joachim G J V; Ferrara, Roberto; Torri, Valter; Hejleh, Taher Abu |
| Source: |
ISSN: 2051-1426 ; Journal for immunotherapy of cancer, vol. 13, no. 2 (2025) e010674. |
| Publication Year: |
2025 |
| Collection: |
Université de Genève: Archive ouverte UNIGE |
| Subject Terms: |
info:eu-repo/classification/ddc/616; Immune Checkpoint Inhibitor; Immunotherapy; Lung Cancer; Humans; Carcinoma; Non-Small-Cell Lung / drug therapy; Non-Small-Cell Lung / mortality; Non-Small-Cell Lung / pathology; Male; Antibodies; Monoclonal; Humanized / therapeutic use; Female; Lung Neoplasms / drug therapy; Lung Neoplasms / mortality; Lung Neoplasms / pathology; Aged; Middle Aged; Registries; B7-H1 Antigen / antagonists & inhibitors; B7-H1 Antigen / metabolism; Antineoplastic Agents; Immunological / therapeutic use; Adult; 80 and over |
| Description: |
Background: 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)≥50%. However, real-world data on its long-term efficacy remains sparse. Methods: 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≥50%, 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 "KN024 look-alike" cohort by excluding patients with an Eastern Cooperative Oncology Group-performance status (ECOG-PS)≥2, those requiring corticosteroids with doses ≥10 mg 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. Results: 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% CI: 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% CI: 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39904562; unige:183983 |
| Availability: |
https://archive-ouverte.unige.ch/unige:183983 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.B6E4218B |
| Database: |
BASE |