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.
Xiuning Le, Antonio Passaro, Yuanyuan Zhao et al.
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In 30 seconds
The HARMONi trial evaluated the efficacy and safety of ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after progression on EGFR TKI therapy. This multicenter, randomized, double-blind phase 3 trial included 438 patients. The median progression-free survival was 6.8 months for ivonescimab plus chemotherapy compared to 4.4 months for placebo plus chemotherapy (HR 0.52; p<0.0001).
Key findings
- Median progression-free survival was 6.8 months in the ivonescimab group versus 4.4 months in the placebo group (HR 0.52; p<0.0001).
- Median overall survival was 16.8 months for ivonescimab plus chemotherapy compared to 14.0 months for placebo plus chemotherapy (HR 0.79).
- Serious treatment-related adverse events occurred in 28% of patients receiving ivonescimab versus 15% in the placebo group.
Why it matters
This study provides evidence that ivonescimab combined with chemotherapy can significantly improve progression-free survival in patients with advanced EGFR-mutated non-small-cell lung cancer after prior TKI therapy, highlighting a potential new treatment option in this challenging patient population.