Breakthrough Data on Ivonescimab for NSCLC Treatment
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Groundbreaking Phase III Data on Ivonescimab
At the IASLC 2024 World Conference on Lung Cancer (WCLC 2024), Akeso is excited to present their latest research on ivonescimab, a first-in-class PD-1/VEGF bispecific antibody. This data showcases the success of ivonescimab in comparison to pembrolizumab, especially for patients battling PD-L1 positive non-small cell lung cancer (NSCLC).
Key Findings from the Phase III Study
The trial demonstrated that ivonescimab provides a significant median progression-free survival (mPFS) advantage of 11.15 months, over 5.82 months with pembrolizumab, indicating its potential superior efficacy in a real-world clinical setting.
Overall Survival Rates
In the intention-to-treat (ITT) population, the hazard ratio (HR) of 0.51 (P<0.0001) indicates a 49% reduction in the risk of disease progression or death when using ivonescimab. The objective response rate (ORR) improved to 50.0%, compared to just 38.5% with pembrolizumab, with a disease control rate (DCR) of 89.9% for ivonescimab versus 70.5% for pembrolizumab.
Subgroup Efficacy Analysis
Subgroup analyses found that ivonescimab continued to outperform pembrolizumab across various demographics and clinical presentations, including age, sex, ECOG performance status, and histological types.
PD-L1 Expression Outcome
In patients with high PD-L1 expression (TPS ?50%), ivonescimab's PFS HR was remarkably low at 0.46, indicating a 54% reduction in progression or death, while for lower expressions (1-49%), the PFS HR stayed favorable at 0.54.
Safety and Tolerability of Ivonescimab
The data also affirmed that ivonescimab maintains an impressive safety profile. Despite treating a cohort with varying PD-L1 expressions and tumor types, the adverse events were manageable. The incidence of serious treatment-related adverse events in squamous NSCLC patients receiving ivonescimab was comparable to those on pembrolizumab.
Future Studies and Clinical Significance
With these promising results, Akeso's partner Summit plans to initiate the HARMONi-7 trial, aiming to further assess ivonescimab's efficacy in patients with PD-L1 high advanced NSCLC in the near future.
About Ivonescimab and Akeso
Ivonescimab has received approval in China for certain types of advanced NSCLC and represents a transformative drug in immunotherapy due to its dual mechanism targeting both PD-1 and VEGF pathways. Akeso (HKEX: 9926.HK), established in 2012, is dedicated to pioneering innovative biological medicines and has developed a leading R&D system to advance this mission.
Frequently Asked Questions
What is ivonescimab?
Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody developed by Akeso for the treatment of advanced NSCLC.
What were the results of the Phase III study on ivonescimab?
The study demonstrated that ivonescimab significantly improves median progression-free survival and objective response rates compared to pembrolizumab.
What are the future plans for ivonescimab?
Akeso and Summit are planning to conduct further trials, including HARMONi-7, to expand clinical evaluations of ivonescimab.
How does ivonescimab compare to pembrolizumab?
Ivonescimab shows better response rates and progression-free survival compared to pembrolizumab in clinical trials.
What is Akeso's role in the development of ivonescimab?
Akeso is responsible for the research, development, and commercialization of ivonescimab, focusing on innovative treatments in oncology.
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