New Indication: Adjuvant Pembrolizumab in NSCLC


  • Study

    Randomised, triple-blind, phase 3 trial
    Stage IB (tumours of ≥4 cm in diameter), II, or IIIA NSCLC
    Pembrolizumab 200 mg (590) or placebo (587) / 3 weeks-18 cycles



  • Efficacy

    mDFS: 53.6 m vs 42.0 m (HR 0.76 [95% CI 0.63–0.91], p=0.0014)
    mDFS: NR vs NR in the PD-L1 TPS of 50% or greater population (HR 0.82 [95% CI 0.57–1.18]; p=014).
    3 year OS: 82% vs %80



  • Safety

    Any grade AEs: 96% vs 91%
    Grade ≥3 AEs: 34.7% vs 26.8%
    Discontination due to adverse events: 20% vs 6%
    Death due to adverse events: 2% vs 1%



  • Lancet Oncol. 2022 Sep 9;S1470-2045(22)00518-6.

    Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial

    http://doi.org/10.1016/s1470-2045(22)00518-6

    Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022