Ivonescimab Redefines Lung Cancer Treatment with Promising Phase III Trial Results

Akeso, Inc. (9926.HK) is marking a significant milestone in the fight against lung cancer with its innovative PD-1/VEGF bispecific antibody, ivonescimab. The company has announced "statistically significant and clinically meaningful" results demonstrating an improvement in overall survival (OS) in lung cancer patients, a key achievement that strengthens its position as a potential new global standard of care.

Recently, Akeso reported that the first patient was dosed in its Phase III study (AK112-311/HARMONi-9), which evaluates ivonescimab as consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) after definitive chemoradiotherapy. This is the eighth registrational Phase III clinical trial for ivonescimab in lung cancer, aiming to address an unmet clinical need in an aggressive cancer type with a poor prognosis. In previous studies on extensive-stage SCLC, ivonescimab had already demonstrated its ability to prolong progression-free survival (PFS).

Furthermore, the Chinese company has revealed that ivonescimab has met its overall survival (OS) goal for the first time in the final analysis of the Phase III HARMONi-A study. This China-only trial evaluated the drug in combination with chemotherapy in patients with EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) whose diseases had progressed after tyrosine kinase inhibitor therapies. The results not only reinforce ivonescimab's value in PFS but also highlight its ability to improve OS, a crucial endpoint in global oncology drug development.

Previously, in April 2025, Akeso also announced "strongly positive" results from the Phase III clinical trial (AK112-306/HARMONi-6) for the first-line treatment of advanced squamous NSCLC. In this study, ivonescimab in combination with chemotherapy significantly outperformed tislelizumab plus chemotherapy in terms of PFS, in both PD-L1-positive and negative populations. These results position ivonescimab to improve upon and potentially replace the current standard of care for NSCLC treatment.

With these results, ivonescimab redefines lung cancer treatment.These advancements consolidate Akeso's "IO 2.0" strategy, which aims to expand ivonescimab's therapeutic coverage across various lung cancer indications and treatment lines. Akeso's therapy is being positioned as a rival to key drugs like Merck's Keytruda, and its positive results increase expectations for the global HARMONi trial, which could replicate these benefits in Western populations and support FDA approval.

---

🔖 Sources

Akeso says its closely watched drug improved patient survival in a lung cancer trial

Akeso, Summit's PD-1xVEGF drug meets overall survival goal for the first time in a lung cancer trial

Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy

---