New Drug: Ivonescimab for PD-L1 Positive NSCLC

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

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])

Grade ≥3 AE: 29% vs 16% (ivonescimab vs pembrolizumab)

Immune-related Grade ≥3 AE: 7% vs 8%

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

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