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Poster Display session

53P - Real-world outcomes of first-line pembrolizumab (Pem) for metastatic non-small cell lung cancer (mNSCLC) with ≥50% expression of programmed cell death-ligand 1 (PD-L1): A multicentre retrospective study


31 Mar 2023


Poster Display session


Javier Perea


Journal of Thoracic Oncology (2023) 18 (4S): S35-S88.


J. Perea1, E. Gómez2, C. Escrivá2, A.V. Pellicer3, P. Llor Rodriguez4, J. Iranzo3, O.J. Juan Vidal1, J. García Sanchez3, G. Suay Montagud2, A. Ferrero Micó2, J.D. Linares Diaz2, N. Gómez Sepúlveda2, E. Soria Hernández2, J.M. Esteve Gallego2, C. Carrasco2, P. Capdevila Gaudens2

Author affiliations

  • 1 Valencia/ES
  • 2 Hospital Universitari i Politècnic La Fe, Valencia/ES
  • 3 Hospital Arnau de Vilanova, Valencia/ES
  • 4 Hospital Arnau de Vilanova, 46015 - Valencia/ES


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Abstract 53P


Pem is the standard first-line treatment for mNSCLC patients based on the greater benefit showed in a well-designed phase III trial (Keynote-024). However, these data represent only a part of patients (pts) due to the strict selection criteria. Pts’ characteristics in clinical practice are more heterogeneous. The real-world data are useful to validate the trial results and find which patients are suitable for treatment.


Multicentre retrospective study of pts with mNSCLC and PD-L1 expression in tumour cells ≥50%, without actionable mutations, treated with first-line Pem at 2 hospitals in Valencia, Spain. Baseline factors, efficacy and adverse effects were collected. Statistical analysis was carried out with SPSS v25.0.


From January 2017 to January 2021, 109 pts were treated. Median age 69. Men 81.7%. 19.8% had treated brain metastases, 47% had Performance Status (PS) <2. Median follow-up was 11 months (m). Median number of cycles administered was 8; 10 in pts with PS 0–1 and 5 in PS≥2. 43.5% of PS≥2 pts received less than 4 cycles (p = 0.007). Median Overall Survival (mOS) was 12 m (95% Confidence Interval, CI, 8.6–15.4), 16 m in PS 0–1 pts (12.7–19.2) and 10 m (12.6–14.3) in PS≥2 pts (p = 0.019). Median Progression Free Survival (mPFS) was 6 m (3.6–8.3), 10 m in PS 0–1 pts (4.6–15.4), and 4 m in PS≥2 (2.6–5.3) (p < 0.0001). Overall response rate was 43.7%, with 8.2% of complete responses. Disease control rate was 58.2%. Median time to onset of immune-related adverse events (irAEs) was 4 m. Toxicity of any degree was reported in 52.3%, grade (G) ≥3 in 15.6%. Hepatogastrointestinal (24.8%) and skin (20.2%) toxicities, the most common. mPFS in pts with irAEs was 11 m (7.2–14.8) and mOS 29 m (12–46), while those without irAEs had a mPFS of 2 m (0.8–3.2) (p < 0.0001) and mOS of 4 m (2–6) (p < 0.0001).


Real-world data confirm that Pem is an effective, tolerable option for mNSCLC pts with PD-L1 ≥ 50%. PS≥2 pts were not included in the Keynote-024 trial and this subgroup showed significantly shorter mPFS and mOS. The role of Pem in PS≥2 needs to be validated in a prospective phase III trial. Occurrence of irAEs is associated with an increase in mPFS and mOS.

Legal entity responsible for the study

The authors.


Has not received any funding.


All authors have declared no conflicts of interest.

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