Exciting Phase III Data on Ivonescimab
At the IASLC 2024 World Conference on Lung Cancer (WCLC 2024), Akeso is thrilled to share their latest findings on ivonescimab, a groundbreaking PD-1/VEGF bispecific antibody. This research highlights the effectiveness of ivonescimab compared to pembrolizumab, particularly for patients with PD-L1 positive non-small cell lung cancer (NSCLC).
Key Findings from the Phase III Study
The trial revealed that ivonescimab offers a notable median progression-free survival (mPFS) advantage of 11.15 months, compared to 5.82 months for pembrolizumab. This suggests its potential for superior efficacy in real-world clinical scenarios.
Overall Survival Rates
In the intention-to-treat (ITT) population, a hazard ratio (HR) of 0.51 (P<0.0001) indicates a 49% decrease in the risk of disease progression or death with ivonescimab. Additionally, the objective response rate (ORR) improved to 50.0%, versus 38.5% for pembrolizumab, while the disease control rate (DCR) was 89.9% for ivonescimab compared to 70.5% for pembrolizumab.
Subgroup Efficacy Analysis
Further subgroup analyses showed that ivonescimab consistently outperformed pembrolizumab across various demographics and clinical characteristics, including age, sex, ECOG performance status, and histological types.
PD-L1 Expression Outcome
For patients with high PD-L1 expression (TPS ?50%), ivonescimab's PFS HR was impressively low at 0.46, reflecting a 54% reduction in progression or death. For those with lower expressions (1-49%), the PFS HR remained favorable at 0.54.
Safety and Tolerability of Ivonescimab
The data also confirmed that ivonescimab has a commendable safety profile. Even among a cohort with diverse PD-L1 expressions and tumor types, the adverse events were manageable. The rate of serious treatment-related adverse events in squamous NSCLC patients treated with ivonescimab was similar to those receiving pembrolizumab.
Future Studies and Clinical Significance
Given these encouraging results, Akeso's partner Summit is set to launch the HARMONi-7 trial, which aims to further evaluate the efficacy of ivonescimab in patients with PD-L1 high advanced NSCLC in the near future.
About Ivonescimab and Akeso
Ivonescimab has already received approval in China for specific types of advanced NSCLC and is a transformative drug in immunotherapy, targeting both PD-1 and VEGF pathways. Akeso (HKEX: 9926.HK), founded in 2012, is committed to developing innovative biological medicines and has established a leading research and development system to support this mission.
Frequently Asked Questions
What is ivonescimab?
Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody developed by Akeso for treating advanced NSCLC.
What were the results of the Phase III study on ivonescimab?
The study showed that ivonescimab significantly enhances median progression-free survival and objective response rates compared to pembrolizumab.
What are the future plans for ivonescimab?
Akeso and Summit plan to conduct additional trials, including HARMONi-7, to broaden clinical evaluations of ivonescimab.
How does ivonescimab compare to pembrolizumab?
Ivonescimab demonstrates 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, with a focus on innovative oncology treatments.