Overview
- Harmoni-6, a China-only Phase 3 trial, found that ivonescimab plus chemotherapy reduced the risk of death by 34% and lengthened median overall survival to 27.9 months versus 23.7 months for PD-1 plus chemotherapy.
- Ivonescimab is a single bispecific antibody that blocks PD-1 and VEGF, combining immune checkpoint blockade with inhibition of blood-vessel growth in tumors.
- The ivonescimab arm had more bleeding events, with nearly one-quarter of patients experiencing any bleeding and under 3% experiencing severe bleeding compared with about 1% in the control group.
- Experts noted the trial was limited to Chinese patients and that the control group lived longer than expected, so physicians and regulators say global Harmoni-3 data are needed to judge whether the benefit generalizes.
- Summit plans to report Harmoni-3 squamous progression-free survival results later this year and non-squamous results next year and investors and regulators will use those readouts to assess approval prospects and real-world impact.