The phase 3 HARMONi-A trial (NCT05184712) demonstrated significantly improved PFS with ivonescimab plus chemotherapy vs. placebo in EGFR-mutant NSCLC after TKI failure (median PFS, 7.1 vs. 4.8 months; HR, 0.46; p < 0.001), along with a higher ORR (50.6% vs. 35.4%, p = 0.006)129 Based on these results, ivonescimab received approval from China’s National Medical Products Administration in May 2024 for EGFR-mutated non-squamous NSCLC following TKI progression and was granted FDA Fast Track designation in September 2024. The gene discussed is EGFR; the disease is non-small cell lung carcinoma.