Summit Therapeutics released updated two-year survival data for its Phase 3 HARMONi trial evaluating ivonescimab in non-small cell lung cancer, while the FDA decision clock remains active. The company’s follow-up data covers the longer-term course for Western patients, though the update provides limited context on how directly outcomes compare across geographies and treatment subgroups, according to the report. The FDA is still scheduled to make an approval decision for the therapy in the indication by Nov. 14. Investors are now weighing whether durability signals reinforce earlier efficacy and safety findings. With regulators focused on both endpoint confidence and overall benefit-risk, survival follow-up can be decisive in closing remaining gaps. The next milestone for Summit remains the FDA’s action, which will determine whether ivonescimab advances in a high-competition lung cancer market.