Non-Small Cell Lung Cancer

New Drug: Ivonescimab for PD-L1 Positive NSCLC

2025-03-14

  • Study

    Randomised, double-blind, phase 3 trial [HARMONi-2]
    PD-L1-positive advanced non-small cell lung cancer
    Ivonescimab 20 mg/kg IV Q3W vs Pembrolizumab 200 mg IV Q3W

  • Efficacy

    mPFS: 11.1 mos vs 5.8 mos (ivonescimab vs pembrolizumab) (HR: 0.51 [0.38-0.69], p<0.0001)
    PFS in PD-L1 TPS 1-49%: 8.0 mos vs 5.4 mos (HR: 0.54 [0.37-0.78])
    PFS in PD-L1 TPS ≥50%: 11.1 mos vs 8.2 mos (HR: 0.48 [0.29-0.79])

  • Safety

    Grade ≥3 AE: 29% vs 16% (ivonescimab vs pembrolizumab)
    Immune-related Grade ≥3 AE: 7% vs 8%


    • Lancet 2025;405:839-49

    Xiong A,Wang L,Chen J Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China

    http://doi.org/10.1016/S0140-6736(24)02848-4

    Reviewed by Ulas D. Bayraktar, MD on Mar 14, 2025