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 mo...

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Detalles Bibliográficos
Autores: Masini, S, Basa, MA, Calles, A, Cabellos, RA, Echebarria, ID, Puchol, CT, Kareaga, MM, Cabezon-Gutierrez, L, Perez, MCE, Lage, Y, Lorenzo, EG, Navarro, F, Sereno, M, Martínez, SF, García-Benito, C, Pinto, LM, Andrade, CA, Sequero, S, Martinez, JM, Lopez-Martín, A, Martínez, AA, Martín-Soberon, MC, Lucia-Gozalvez, C, Rubio, J, Tallafigo, L, Garrido, A, Peressini, M, Torres-Jimenez, J, Zurera, M, Bote, H, Ponce, S, Paz-Ares, L, Zugazagoitia, J, Baena, J
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p19905
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/19905
Access Level:acceso abierto
Palabra clave: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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