Summit Therapeutics’ bispecific antibody ivonescimab, targeting PD-1 and VEGF pathways, showed statistically significant progression-free survival improvement but failed to demonstrate overall survival benefit in a global Phase 3 trial, clouding its FDA approval prospects. Subgroup analyses revealed regional discrepancies, with better outcomes in Asian patients compared to Western cohorts. These results raise important questions about patient selection and drug efficacy across different populations. Summit acknowledged concerns but highlighted clinical observations supporting the drug’s benefit.