#None #Akeso #Ivonescimab #Pembrolizumab

Positive Survival Results from HARMONi-2 Study

Akeso, Inc. has recently shared positive findings from the Phase III HARMONi-2 study at the 2026 World Conference on Lung Cancer (WCLC). This study is particularly significant as it compares the first-line use of ivonescimab, a next-generation immuno-oncology therapy, with the widely used pembrolizumab in patients diagnosed with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

Study Overview

The HARMONi-2 trial was designed as a randomized, double-blind, multicenter study and was particularly noted for its rigorous methodology and diverse patient population. On September 13, 2026, the data concerning overall survival (OS) was made public on the WCLC’s official website, garnering significant attention within the oncological community. Professor Caicun Zhou, a leading figure in the study, is set to present detailed findings at the conference, offering valuable insights into the clinical implications of ivonescimab.

Key Findings

After 36 months of median follow-up, the results indicated a clear survival advantage for patients treated with ivonescimab over those receiving pembrolizumab. Notably, ivonescimab increased the median OS to 30.8 months compared to 22.6 months for pembrolizumab, translating to a remarkable 27% reduction in the risk of death. This finding was supported across various predefined subgroups, showcasing the strength and consistency of ivonescimab’s benefit, especially among patients with high PD-L1 expression.

Specific Subgroup Analysis

1. Intention-to-Treat Population: The overall survival benefit was significant, underscoring ivonescimab's efficacy over pembrolizumab.

2. High-Risk Squamous Patients: In a cohort traditionally viewed as high-risk for anti-VEGF therapies, ivonescimab did not elevate bleeding risks as feared, showing efficacy in a population previously underserved by treatment options.

3. Variability in PD-L1 Levels: Among patients with PD-L1 TPS ≥50%, the survival advantage was even more pronounced, exhibiting a 42% reduction in the risk of death, contrasted with a 15% reduction in the 1–49% PD-L1 TPS subgroup, reaffirming ivonescimab's profile across diverse patient characteristics.

4. Histological Consistency: Noteworthy is the consistent OS benefit observed regardless of whether patients had squamous or non-squamous histology types, affirming that ivonescimab may offer valid treatment pathways across cancer typologies.

5. Safety Profile: Importantly, the safety profile of ivonescimab remained favorable and comparable to pembrolizumab, with no new safety signals reported, indicating a manageable risk for patients undergoing treatment.

Looking Ahead

The robustness of these results is encouraging as an international multicenter study evaluating ivonescimab is currently underway. This research further validates ivonescimab’s dual mechanisms in combining immunotherapy with anti-angiogenesis, positioning it as a potentially groundbreaking treatment choice within oncology.

About Akeso

Founded in 2012, Akeso, Inc. (HKEX 9926.HK) has emerged as a leader in biopharmaceuticals, emphasizing the development of innovative therapies. With a comprehensive research-driven platform and a strong clinical pipeline, Akeso continues to innovate in areas including oncology, autoimmune diseases, and more.

Conclusion

The findings from the HARMONi-2 study may serve to redefine treatment standards for PD-L1-positive NSCLC, suggesting ivonescimab as a formidable contender. As Akeso progresses in its clinical endeavors, these results will likely shape both clinical practice and patient management strategies in the near future.