Real-World Data of First-Line Cemiplimab Monotherapy for Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression ≥ 50%: A National Spanish Multicentric Cohort (CEMI-SPA Study)

Background/Objectives: Anti–PD-1/PD-L1 blockers have revolutionized the treatment landscape of non–small cell lung cancer (NSCLC) lacking oncogene-addicted alterations, particularly in tumors with high PD-L1 expression (tumor proportion score [TPS] ≥ 50%). Cemiplimab is approved as first-line monoth...

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Detalles Bibliográficos
Autores: Masini, Silvia, Antoñanzas Basa, Monica, Calles, Antonio, Cabellos, Ruth Alvarez, De Elejoste Echebarria, Ibone, Traseira Puchol, Cristina, Martinez Kareaga, Mireia, Cabezon-Gutierrez, Luis, Escoin Perez, Maria Corina, Lage, Yolanda, Garcia Lorenzo, Ester, Navarro, Fatima, Sereno, Maria, Falagán Martínez, Sandra, García-Benito, Carme, Masfarre Pinto, Laura, Avila Andrade, Claudio, Sequero, Silvia, Mosquera Martinez, Joaquín, López-Martín, Ana, Azkárate, Aitor, Martín-Soberón, Maria Cruz, Lucia-Gozalvez, Clara, Rubio, Judit, Tallafigo, Leopoldo, Garrido, Alberto, Peressini, Melina, Torres-Jimenez, Javier, Zurera, María, Bote, Helena, Ponce, Santiago, Paz-Ares, Luis, Zugazagoitia, Jon, Baena, Javier
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/26423
Acceso en línea:https://hdl.handle.net/20.500.13003/26423
Access Level:acceso abierto
Palabra clave:Carcinoma, Non-Small-Cell Lung
Immune Checkpoint Inhibitors
Lung Neoplasms
Immunotherapy
Carcinoma de Pulmón de Células no Pequeñas
Inhibidores de Puntos de Control Inmunológico
Neoplasias Pulmonares
Inmunoterapia
immunotherapy
NSCLC
PD-L1
Descripción
Sumario:Background/Objectives: Anti–PD-1/PD-L1 blockers have revolutionized the treatment landscape of non–small cell lung cancer (NSCLC) lacking oncogene-addicted alterations, particularly in tumors with high PD-L1 expression (tumor proportion score [TPS] ≥ 50%). Cemiplimab is approved as first-line monotherapy in this setting. However, real-world data remain scarce. This study aimed to evaluate the efficacy and safety of single-agent cemiplimab in a multicenter Spanish cohort and compare outcomes with a historical pembrolizumab cohort. Methods: Cemi-SPA is a retrospective multicenter study including 150 patients with advanced NSCLC and PD-L1 ≥ 50% treated with cemiplimab as first-line monotherapy across 21 Spanish centers. Clinical outcomes were analyzed and compared with a historical cohort of 144 patients treated with pembrolizumab. Propensity score matching (PSM) was performed to adjust for baseline differences. Results: Median progression-free survival (PFS) and overall survival (OS) were 8.1 and 12.6 months, respectively. ECOG performance status ≥ 2 was independently associated with worse outcomes, whereas the development of immune-related adverse events correlated with improved PFS and OS. After PSM, no significant differences were observed between cemiplimab and pembrolizumab in terms of efficacy. Conclusions: Cemiplimab demonstrated comparable real-world efficacy and safety to pembrolizumab in patients with advanced NSCLC and PD-L1 ≥ 50%. ECOG performance status emerged as the strongest prognostic factor, highlighting the importance of patient selection in routine clinical practice.

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