Ivonescimab

An estimated 10–15% of NSCLC cases have an EGFR mutation. This proportion is not a population incidence rate. NSCLC symptoms include persistent cough, dyspnea, chest pain, fatigue, appetite loss, and weight loss. In a U.S. claims study including 409 participants with EGFR-mutated advanced NSCLC, mean all-cause healthcare costs per patient per month were $27,751 during first-line treatment, $28,971 during second-line treatment, and $31,251 during third-line treatment. These are disease-management costs, not estimates of the cost of ivonescimab.

HARMONi randomized 438 participants. In the 345-participant primary PFS analysis, median PFS was 6.8 months with ivonescimab plus chemotherapy and 4.4 months with placebo plus chemotherapy, with an HR of 0.52. The primary OS comparison was not statistically significant: median OS was 16.8 versus 14.0 months, with an HR of 0.79 and p=0.057. Grade 3 or higher TRAEs occurred in 50.0% versus 42.2%.

In HARMONi-A, 322 participants were randomized. Final median OS was 16.8 versus 14.1 months, with an HR of 0.74 and P=.02. Grade 3 or higher TEAEs occurred in 67.1% versus 54.7%. TEAEs and TRAEs are different safety measures and should not be treated as interchangeable.

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.