The FDA has accepted a Biologics License Application for ivonescimab (AK112), a new bispecific antibody for patients with EGFR-mutated, nonsquamous non-small cell lung cancer that has progressed after third-generation TKI treatment.
Phase 3 HARMONi trial data from 438 patients showed that ivonescimab combined with chemotherapy significantly slowed disease progression. Median progression-free survival improved from 4.4 to 6.8 months, and overall survival showed a positive trend, increasing from 14.0 to 16.8 months. Patients with brain metastases benefited the most, with a 66% lower risk of progression. Data from North America and Europe confirmed consistent survival benefits.
Ivonescimab works by blocking both PD-1 and VEGF pathways, boosting the immune response and cutting off the tumor’s blood supply. Side effects were generally manageable but included higher rates of hypertension, protein in the urine, thyroid problems, and skin rashes compared with chemotherapy alone.