Ivonescimab Shows Promise in Lung Cancer Treatment at ESMO 2025

2025-10-20 transformation

Berlin, Monday, 20 October 2025.
At ESMO 2025, ivonescimab demonstrated improved progression-free survival in lung cancer patients, showing a median PFS of 11.1 months compared to 6.9 months with tislelizumab.

Groundbreaking Results from HARMONi-6 Trial

At the European Society for Medical Oncology (ESMO) 2025 conference held in Berlin, the HARMONi-6 trial results highlighted the potential of ivonescimab as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC). The trial demonstrated a median progression-free survival (PFS) of 11.1 months for patients treated with ivonescimab, compared to 6.9 months for those receiving tislelizumab, representing a significant improvement in survival outcomes. The hazard ratio (HR) was noted as 0.60 with a 95% confidence interval (CI) of 0.46–0.78, and a P-value of less than 0.0001, indicating a substantial reduction in the risk of disease progression or death [1][2][3].

Comparative Efficacy and Safety

Ivonescimab, a bispecific antibody targeting both PD-1 and VEGF, has shown consistent efficacy across various subgroups, regardless of PD-L1 expression status. In patients with PD-L1 expression below 1%, the ivonescimab group achieved a PFS of 9.9 months compared to 5.7 months in the control group, with a hazard ratio of 0.55. For those with PD-L1 expression of 1% or more, the PFS was 12.6 months versus 8.6 months, with a hazard ratio of 0.66 [1][2][3]. Despite these promising results, the safety profile of ivonescimab requires careful consideration, as grade 3 or higher treatment-related adverse events occurred in 63.9% of patients, compared to 54.3% with tislelizumab [2][4].

Strategic Developments in Global Trials

The promising results from the HARMONi-6 trial have paved the way for further investigation of ivonescimab in global clinical trials. Summit Therapeutics is planning to submit a Biologics License Application (BLA) in the fourth quarter of 2025, aiming for regulatory approval beyond China. The ongoing HARMONi-3 trial is a key part of this strategy, designed to evaluate ivonescimab in a larger, more diverse patient population, including both squamous and non-squamous NSCLC subtypes [4][5]. This trial’s focus on progression-free survival as a primary endpoint may alleviate some of the pressure to demonstrate an especially strong overall survival benefit immediately [5].

Implications for Future Oncology Practices

While ivonescimab shows significant promise, its ultimate impact on clinical practice will depend on the translation of PFS benefits into overall survival gains and the replication of results in diverse populations. The HARMONi-3 trial, with its expanded enrollment target and revised endpoints, seeks to provide robust data that could solidify ivonescimab’s position in the global oncology treatment landscape. The potential approval of ivonescimab could mark a significant advancement in the treatment options available for NSCLC patients worldwide, offering a new standard of care in settings where PD-1 inhibitors like Keytruda currently dominate [4][5][6].

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lung cancer ivonescimab