Ivonescimab

The phase 3 evidence supports a PFS benefit over chemotherapy alone in the studied post-EGFR-TKI population. HARMONi-A reported a statistically significant final OS result, whereas HARMONi did not meet its primary OS comparison. The later HARMONi HR of 0.76 is an updated follow-up result and should be distinguished from the primary test. Grade 3 or higher adverse events were more frequent in the ivonescimab groups, using each trial’s reported safety definition.

Ivonescimab has marketing authorization in China. The reported U.S. FDA action date is November 14, 2026; a pending application is not a U.S. approval. The economic evidence in this report includes a cost-effectiveness model, not an ivonescimab budget-impact model.