By Fineline Cube 
Akeso Inc. (HKG: 9926) today disclosed the results of its global first‑in‑class bispecific antibody ivonescimab (PD‑1/VEGF) in combination with chemotherapy versus tislelizumab + chemotherapy as first‑line therapy for advanced squamous non‑small cell lung cancer (sq‑NSCLC). The data from the registrational Phase III study AK112‑306 / HARMONi‑6 were presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress 2025.
Key Findings
| Endpoint | Ivonescimab + Chemo | Tislelizumab + Chemo | Statistical Significance |
|---|---|---|---|
| Median Progression‑Free Survival (mPFS) | 11.14 months | 6.90 months | HR 0.60, P < 0.0001 |
| PD‑L1 Stratified Benefit | Significant benefit regardless of PD‑L1 status | – | – |
| Liver Metastases / Metastatic Sites | Benefit maintained across sub‑groups | – | – |
| Safety Profile | No new safety signals; comparable TRAEs, irAEs, Grade 3 bleeding | Comparable | – |
- Safety – Treatment‑related serious adverse events, immune‑related adverse events, and Grade 3 bleeding events were similar to the tislelizumab arm. The most common adverse reactions were chemotherapy‑related myelosuppression.
Strategic Context
- First‑in‑Class – Ivonescimab is the world’s first approved bispecific antibody that couples PD‑1 blockade with VEGF inhibition, delivering a synergistic “immuno‑oncology + anti‑angiogenesis” mechanism.
- Regulatory Milestones – Approved by China’s National Medical Products Administration (NMPA) in May 2024 for locally advanced or metastatic non‑squamous NSCLC post‑EGFR‑TKI progression; added to the National Reimbursement Drug List in November 2024.
- Market Impact – The Phase III data position ivonescimab as a compelling first‑line option for sq‑NSCLC, potentially reshaping the therapeutic landscape and expanding Akeso’s global footprint.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech