Abstract 45P
Background
Our previous analyses showed that cemiplimab monotherapy has a favorable safety profile and efficacy outcomes in NSCLC with high PD-L1 expression. We present an extended follow–up.
Methods
Advanced NSCLC patients (pts) with PD-L1 TPS ≥50% who received first-line cemiplimab across 21 Spanish centers were included. Safety, efficacy, and associations with clinical characteristics were analyzed using log-rank tests and Cox regression models.
Results
Between May 2022 and September 2023, 150 pts were included. The median age was 70 years, 94.6% of pts had tobacco exposure, 85.3% had an ECOG performance status (PS) of 0–1, 88.0% had stage IV disease, and 22.8% had squamous (sq) histology. Extrathoracic disease was observed in 60.8% of pts, with ≥3 metastatic sites in 20.7%. KRAS mutations were detected in 19.3% of cases using Next Generation Sequencing (NGS). After a median follow-up of 17.8 months (m), the median progression-free survival (PFS)was 7.9 m(95% CI, 4.3–11.4), and the median overall survival (OS) was 12.6 m (95% CI, 10.2–15.1). The overall response rate (ORR) and disease control rate (DCR) were 56.9% and 61.7%, respectively. Immune-related adverse events occurred in 28.7% of pts and led to treatment discontinuation in 13.3% of cases. Statistically significant variables (P-values
Conclusions
This study provides the first real-world data (RWD) on cemiplimab in patients with advanced NSCLC and PD-L1 TPS ≥50%. Extended follow-up confirmed a manageable safety profile of cemiplimab and showed that poor PS, stage IV disease, and sq histology are associated with reduced survival in this population.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.