KEY TAKEAWAYS
- The MK-3475-671/KEYNOTE-671 phase III trial evaluated OS in early-stage NSCLC patients with perioperative pembro vs. chemo alone.
- The primary endpoints were EFS and OS.
- The study demonstrated that neoadj pembro+ chemo followed by resection and adjuvant pembro significantly improved OS compared to neoadj chemo alone, establishing its potential as a new SOCfor early-stage NSCLC.
In the early-stage non-small cell lung cancer(NSCLC) study (KEYNOTE-671), neoadjuvant(neoadj) pembrolizumab(pembro) + chemotherapy(chemo) followed by resection and adjuvant pembro showed improved outcomes compared to neoadj chemo and resection alone.
Researchers aimed to assess the overall survival (OS) of early-stage NSCLC patients(pts) who received pembro as part of a perioperative treatment regimen compared to those who received chemo alone.
The study randomized 1:1 resectable stage II, IIIA, or IIIB (N2) NSCLC pts per AJCC v8 to receive either pembro 200 mg (n = 397) or placebo (n = 400) every 3 weeks. They were to undergo 4 cycles of neoadj pembro or placebo in addition to cisplatin-based chemo and up to 13 cycles of adjuvant pembro or placebo. The primary endpoints were event-free survival (EFS) and OS.
The median time from randomization to the data cutoff on July 10, 2023, was 36.6 months (range 18.8-62.0). With 254 (31.9%) deaths, OS significantly improved in the pembro arm (HR 0.72 [95% CI 0.56-0.93]; P = 0.00517). Median OS was not reached (NR) (95% CI NR-NR) in the pembro arm vs 52.4 months (95% CI 45.7-NR) in the placebo arm; 36-month OS rates were 71.3% vs 64.0%.
EFS continued to improve in the pembro arm (HR 0.59 [95% CI 0.48-0.72]; median [95% CI] 47.2 months [32.9-NR] vs 18.3 months [14.8-22.1]; 36-month rate, 54.3% vs 35.4%). Treatment-related adverse events (TRAEs) were grade ≥3 in 45.2% of pts in the pembro arm vs 37.8% in the placebo arm, leading to discontinuation of all treatment in 20.2% vs 9.3%, and leading to death in 1.0% vs 0.8% (no new treatment-related deaths since the first interim analysis).
The study demonstrated that neoadj pembro+ chemo followed by resection and adjuvant pembro significantly improved OS compared to neoadjuvant chemotherapy alone, establishing its potential as a new standard of care for early-stage NSCLC.
Clinical Trial: https://clinicaltrials.gov/study/NCT03425643
Spicer JD, Gao S, Liberman M, Kato T, Tsuboi M, Lee S, Chen K, Dooms C, Majem M, Eigendorff E, Martinengo G, Bylicki O, Garassino MC, Rodriguez Abreu D, Chaft J, Novello S, Yang J, Keller SM, Samkari A, Wakelee H. Annals of Oncology (2023) 34 (suppl_2): S1254-S1335. 10.1016/annonc/annonc1358.
