Pharma BD Deal Intelligence
Summit Therapeutics licensed exclusive rights to ivonescimab, a PD-1/VEGF bispecific antibody, from Akeso for markets outside Greater China (US, Canada, Europe, Japan) in a December 2022 collaboration worth $500M upfront and up to $5B with milestones (deal closed January 2023). Development has since advanced materially: the U.S. FDA accepted Summit's BLA on January 29, 2026 for ivonescimab plus chemotherapy in EGFR-mutated NSCLC post-3rd-generation TKI (Phase III HARMONi, PFS HR 0.52), with a PDUFA goal action date of November 14, 2026. At ASCO 2026, the Akeso-run Phase III HARMONi-6 showed a statistically significant overall-survival benefit versus tislelizumab plus chemotherapy in first-line squamous NSCLC (OS HR 0.66). The global HARMONi-3 trial (first-line non-squamous NSCLC vs pembrolizumab) is the pivotal US readout, with final PFS data expected in the second half of 2026.