Non-small cell lung cancer driven by EGFR mutations, after the disease has progressed on a targeted TKI — a point where durable options run thin.
Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF in a single molecule, and Summit Therapeutics is filing it in combination with chemotherapy. It is aimed at patients whose EGFR-mutated, non-squamous non-small cell lung cancer has progressed after an EGFR-targeted TKI — a setting of real unmet need once targeted therapy stops working. The BLA is built on the Phase III HARMONi trial and holds FDA Fast Track designation, with a November 14 target action date. Lung cancer is one of oncology's largest and most contested markets. Watch the breadth of the approved label and how ivonescimab is positioned against standard chemotherapy in this post-TKI population.