Akeso 的 ivonescimab 在肺癌臨床試驗中展現強勁數據

🔑 增強重點摘要

•The HARMONi-6 trial demonstrated a statistically significant 34% reduction in the risk of death for patients treated with ivonescimab plus chemotherapy, compared to tislelizumab plus chemotherapy, in first-line advanced squamous non-small cell lung cancer (NSCLC).
•This marks a historic achievement for China's biotech industry, as ivonescimab is the first China-originated investigational oncology drug to be selected for presentation in a Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting.
•Ivonescimab has previously shown superior progression-free survival (PFS) compared to pembrolizumab monotherapy in first-line PD-L1-positive NSCLC (HARMONi-2 trial) and has demonstrated dual overall survival (OS) and PFS benefits in EGFR-mutant non-squamous NSCLC after TKI failure.
•The survival benefit observed in the HARMONi-6 trial was consistent across various patient subgroups, including those with PD-L1-negative and PD-L1-positive tumors, notably showing a 36% reduction in death risk for patients with very low PD-L1 expression (<1%).
•Akeso has partnered with Summit Therapeutics for the development and commercialization of ivonescimab in key global markets including the United States, Canada, Europe, and Japan, indicating a significant international collaboration.

📊 競品分析▸ Show

Feature/Drug	Ivonescimab (Akeso/Summit Therapeutics)	Tislelizumab (BeOne Medicines/BeiGene)	Pembrolizumab (Merck's Keytruda)
Drug Class	First-in-class PD-1/VEGF bispecific antibody	PD-1 inhibitor	PD-1 inhibitor
Mechanism	Dual blockade of PD-1 and VEGF-A, with cooperative binding and tetravalent structure.	Blocks PD-1 to reactivate T-cells.	Blocks PD-1 to reactivate T-cells.
HARMONi-6 (sq-NSCLC)	Reduced risk of death by 34% vs. tislelizumab + chemo. Median OS: 27.9 months.	Control arm in HARMONi-6. Median OS: 23.7 months (with chemo).	Not directly compared in HARMONi-6.
HARMONi-2 (PD-L1+ NSCLC)	Median PFS: 11.1 months (monotherapy).	Not directly compared in HARMONi-2.	Median PFS: 5.8 months (monotherapy).
Safety Profile	Favorable, comparable to tislelizumab + chemo in HARMONi-6, though higher rates of hemorrhage (24.8% vs 12.1% any grade) and blood clots (9 vs 4) were noted.	Favorable safety profile in HARMONi-6 control arm.	Acceptable, with grade ≥3 TRAEs of 16% in HARMONi-2.
Approval Status	Approved in China (May 2024). Investigational in US, EU, Japan.	Approved in China for first-line squamous NSCLC. Approved in EU for various indications.	Widely approved globally for various cancer types, including NSCLC.
Global Market	Positioned as potential backbone therapy in US$20 billion global market.	Generated US$737 million in global sales in 2025.	Leading immunotherapy with significant market share.

🛠️ 技術深入

Ivonescimab is a novel, first-in-class, IgG1-scFv humanized, tetravalent bispecific monoclonal antibody.
It is engineered to simultaneously target two critical pathways: Programmed Death-1 (PD-1) and Vascular Endothelial Growth Factor A (VEGF-A).
A key technical feature is its unique cooperative binding mechanism, where the presence of one target (e.g., VEGF) reciprocally augments its binding affinity for the other target (PD-1), leading to over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro.
This tetravalent structure and cooperative binding are designed to enhance its preferential accumulation and activity within the tumor microenvironment, where both PD-1 and VEGF are often highly expressed, potentially improving efficacy and reducing systemic side effects.
By blocking PD-1, ivonescimab reactivates cytotoxic T-cells to mount an anti-tumor response, while its inhibition of VEGF-A suppresses tumor angiogenesis, normalizes tumor vasculature, and enhances immune cell infiltration into the tumor.
The antibody features an Fc-silent IgG1 design, which results in reduced FcγR interactions and minimal Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP) activities, contributing to its observed safety profile.

🔮 前景展望基於引用來源的 AI 分析

Ivonescimab is poised to become a new standard of care for advanced squamous non-small cell lung cancer.

Its statistically significant and clinically meaningful improvement in overall survival in a head-to-head Phase III trial against an established PD-1 inhibitor plus chemotherapy sets a new benchmark for treatment efficacy.

The success of ivonescimab will significantly elevate the global standing and adoption of innovative oncology drugs originating from China.

Being the first China-originated investigational oncology drug to be featured in an ASCO Plenary Session underscores a pivotal shift in global biotech innovation and recognition, often referred to as China's 'DeepSeek moment' in biotech.

The bispecific antibody class targeting both PD-1 and VEGF will see accelerated development and investment.

Ivonescimab's strong clinical results validate the therapeutic potential of this dual-target approach, likely encouraging further research and development in similar bispecific molecules for various cancer types.

⏳ 時間線

2022-12

Summit Therapeutics licenses ivonescimab rights for major global markets from Akeso.

2023-08

New Drug Application (NDA) for ivonescimab accepted by China's NMPA CDE.

2023-10

Ivonescimab's novel cooperative binding and tetravalent structure mechanism presented at SITC 2023.

2024-05

Ivonescimab receives approval in China from the National Medical Products Administration (NMPA).

2025-03

HARMONi-2 trial results published in The Lancet, showing ivonescimab's superior PFS vs. pembrolizumab in PD-L1+ NSCLC.

2026-02

Ivonescimab granted its fifth Breakthrough Therapy Designation by China's NMPA for advanced biliary tract cancer.

2026-05

HARMONi-6 trial results presented at ASCO Plenary Session, demonstrating significant overall survival benefit in squamous NSCLC.

Akeso 的 ivonescimab 在肺癌臨床試驗中展現強勁數據

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關鍵要點

🧠 深度解析

🔑 增強重點摘要

🛠️ 技術深入

🔮 前景展望基於引用來源的 AI 分析

⏳ 時間線

📎 來源 (20)

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