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Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial (HARMONi)

*May 2024*

Question  Among patients with non–small cell lung cancer with the epidermal growth factor receptor (EGFR) variant who experienced resistance to EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment, does the addition of ivonescimab (a bispecific antibody targeting programmed cell death 1 protein and vascular endothelial growth factor) to chemotherapy improve progression-free survival compared with chemotherapy alone?

Findings  In this phase 3 trial that enrolled 322 patients whose disease progressed while receiving EGFR-TKI treatment, ivonescimab plus chemotherapy significantly improved progression-free survival compared with placebo plus chemotherapy. Median progression-free survival was 7.06 months with ivonescimab vs 4.80 months with placebo.

Meaning  Ivonescimab plus chemotherapy significantly improved progression-free survival with tolerable safety profile in patients with non–small cell lung cancer who previously underwent EGFR-TKI treatment and may offer a new treatment option for patients with TKI resistance. Read more.