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)

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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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Journal
Cancers
Published
2025-11-13
DOI
https://doi.org/10.3390/cancers17223643
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
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article

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)

Manel Cremades Pérez, R. Álvarez Cabellos, Javier Baena, Judit Rubio et al.
Cancers
Cancer Immunotherapy and Biomarkers
article

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)

Manel Cremades Pérez, R. Álvarez Cabellos, Javier Baena, Judit Rubio, M Castellano Zurera, Y. Lage, Maria Cruz Martín-Soberón, María Sereno, Claudia A. Andrade, Carmé García-Benito, M. Martínez Kareaga, Luis Cabezón‐Gutiérrez, Santiago Ponce-Aix, Silvia Sequero, C. Traseira Puchol, Joaquín Mosquera, M. Antoñanzas, I. De Elejoste Echebarria, Javier Torres-Jiménez, Jon Zugazagoitia, Aitor Azkárate, Helena Bote, Silvia Masini, S. Falagán Martínez, L. Masfarre Pinto, Antonio Calles, Clara Lucia-Gozalvez, Melina Peressini, Alberto Garrido, Luis Paz‐Ares, Ana López Martín, Fátima Navarro, Elena Lorenzo, Leopoldo Tallafigo
article en

Abstract

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.

CancersVol. 17(22)
Humanitas University (IT), Hospital General Universitario Gregorio Marañón (ES), Hospital Clínico San Carlos (ES), Research Institute Hospital 12 de Octubre (ES), Hospital Universitario de Torrejón (ES), Hospital de La Ribera (ES), Hospital Universitario Príncipe de Asturias (ES), Hospital Universitario Araba (ES), Instituto de Investigación Biosanitaria de Granada (ES), Hospital Universitario Fundación Jiménez Díaz (ES), Hospital Del Mar (ES), Donostiako Unibertsitate Ospitalea (ES), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitari Sant Joan de Reus (ES), Hospital Universitario Lluís Alcanyís (ES), Hospital Universitario del Henares (ES), Hospital Universitario Son Espases (ES), Hospital Jerez Puerta del Sur (ES), Hospital Universitario de Móstoles (ES), Complejo Hospitalario de Pontevedra (ES), Hospital Universitario Severo Ochoa (ES), Hospital Universitario Infanta Sofía (ES), Hospital Universitario Ramón y Cajal (ES), Complejo Hospitalario Universitario de Toledo (ES), Complejo Hospitalario de Ourense (ES), Hospital Universitario Infanta Leonor (ES), Hospital Universitario de Toledo (ES)
Openalex Percentile: Top 53%
Cancer Immunotherapy and Biomarkers
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