Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial

Adding ivonescimab to chemotherapy prolonged progression-free survival but NOT overall survival. In the phase 3 HARMONi trial (n=438, EGFR-mutated non-small-cell lung cancer after progression on a third-generation EGFR inhibitor), median progression-free survival was 6.8 versus 4.4 months (HR 0.52; 95% CI 0.41-0.66; p<0.0001). Median overall survival was 16.8 versus 14.0 months and did not reach statistical significance (HR 0.79; 95% CI 0.62-1.01) — this was the second of the two co-primary endpoints. Serious treatment-related adverse events occurred in 28% of patients versus 15% in the control group.