Ivonescimab
Ivonescimab is a PD-1/VEGF bispecific antibody developed by Akeso, which sells it in China. Summit Therapeutics holds the rights in the Americas, Europe, Japan, the Middle East and Africa. The next event is the FDA decision on Ivonescimab, on Nov 14, 2026 (source).
- Also known as
- AK112, SMT112
- Company
- Summit Therapeutics (SMMT) · Rights in the Americas, Europe, Japan, the Middle East and Africa
- How it works
- PD-1/VEGF bispecific antibody
- Approved
- China (Akeso)
Development by disease
| Non-small cell lung cancer | Filed |
| Colorectal cancer | Phase 3 |
| Head and neck squamous cell carcinoma | Phase 3 |
| Urothelial carcinoma | Phase 2/3 |
Upcoming events
Firm dates · a specific day set by the company or regulator
Next 60 days
- Nov 14in 32 daysIvonescimab · FDA decision · Non-small cell lung cancer · EGFRm+ · second-line or later
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in H2 2026
- H2 2026Ivonescimab · Phase 3 results (HARMONi-3) · Non-small cell lung cancer · first-line · squamous
Expected in H1 2027
- H1 2027Ivonescimab · Phase 3 results (HARMONi-3) · Non-small cell lung cancer · first-line · non-squamous
Past results and milestones
- Sep 29, 2026HARMONi-3 Phase III enrollment completed by end of Q2 2026 as previously guided. Source
- Sep 15, 2026HARMONi-GI1 Phase III trial achieved statistically significant OS superiority for ivonescimab + chemotherapy vs durvalumab + chemotherapy as first-line treatment in advanced biliary tract cancer at pre-specified interim analysis. Detailed results and safety data presented at WCLC 2026. Source
- Nov 7, 2025HARMONi longer-term OS analysis completed in September 2025, showing improved nominal p-value (0.0332) with OS HR 0.78 (95% CI: 0.62–0.98), now statistically significant. Results support BLA submission intent for ivonescimab + chemotherapy in EGFRm NSCLC post-TKI progression. Source
- May 30, 2025HARMONi topline results announced: primary PFS endpoint met with statistically significant benefit (HR 0.52, p<0.00001). Secondary OS endpoint showed positive trend (HR 0.79, p=0.057) without statistical significance. Consistent results with single-region HARMONi-A study. Source
- Apr 25, 2025The NMPA approved ivonescimab as monotherapy for first-line treatment of advanced NSCLC with positive PD-L1 expression on April 25, 2025, based on HARMONi-2 trial results showing an interim OS hazard ratio of 0.777. Source
- Apr 23, 2025The HARMONi-6 Phase III trial met its primary endpoint of progression-free survival at a prespecified interim analysis, demonstrating a statistically significant and clinically meaningful improvement for ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in first-line squamous NSCLC, with no new safety signals identified. Source