The five-year benefit demonstrated across overall 
survival and event-free survival from KEYNOTE-671 sup-
ports the continued use of this pembrolizumab-based 
perioperative regimen as a standard of care for patients 
with resectable, earlier-stage non-small cell lung cancer,” 
Wakelee advised.  “These consistent results are impact-
ful, as they reflect the importance of intervening for cer-
tain patients with earlier stages of non-small cell lung 
cancer. ”
More recently, in a study published earlier this year 
in the European Journal of Cardiothoracic Surgery, 
researchers including Wakelee did a subgroup analysis 
of participants with stage II NSCLC.  They found that peri-
operative pembrolizumab “improved efficacy outcomes 
with manageable safety versus neoadjuvant chemo-
therapy alone, consistent with the overall KEYNOTE-671 
population.  These results support the use of this regimen 
in patients with stage II disease. ”2 
“Historically, patients with advanced non-small cell 
lung cancer faced a poor prognosis, with long-term 
survival considered unlikely,” added Edward B.  Garon, 
MD, MS, professor of medicine, principal investigator 
for KEYNOTE-001, David Geffen School of Medicine, 
the University of California, Los Angeles.  “The long-term 
results from these four trials show that pembrolizumab 
has helped change what certain patients with advanced 
NSCLC can hope to achieve. ” 
1 Wakelee H, Spicer J, Gao S, et.  Al.  LBA67 Perioperative pem-
brolizumab in early-stage non-small- cell lung cancer (NSCLC): 
5-year follow-up from KEYNOTE- 671.  ESMO Annals of Oncol-
ogy.  DOI: 10. 1016/j. annonc. 2025. 09. 079 
2 Tsuboi M, Wakelee H, Garassino MC, Gao S, et.  Al.  Subgroup 
Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-
Small-Cell Lung Cancer from the Randomized KEYNOTE-671 
Study.  Eur J Cardiothorac Surg.  2026 Mar 10;68(3):ezag028.  doi: 
10. 1093/ejcts/ezag028.  PMID: 41875364; PMCID: PMC13020334.
Source: Heymach JV, Harpole D, Mitsudomi T, et al. ; AEGEAN Investigators. Perioperative durvalumab for resectable non-small-cell lung cancer. N Engl J Med. 
2023;389:1672-1684.
	
	
2 0 2 6  C O M P E N D I U M  O F  F E D E R A L  M E D I C I N E  
7 1
A Subgroup Analysis of Perioperative Pembrolizumab in Clinical Stage II Non-Small-Cell  
Lung Cancer From the Randomized KEYNOT-671 Study
SUMMARY
In participants with 
clinical stage II NSCLC 
in KEYNOTE-671 
(n=239), neoadjuvant 
pembrolizumab improves 
EFS, OS, MPR, and 
pCR versus neoadjuvant 
chemotherapy alone.  
These findings support 
the use of this regimen 
in patients with clinical 
stage II NSCLC.
Legend: EFS, event-free survival; MPR, major pathological response; NSCLC, non-
small-cell lung cancer; pCR, pathological complete response; OS, overall survival.

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