What is the therapeutic effect of Ivonescimab injection?

Ivonescimab injection (Ivonescimab) is a new drug that has made important progress in the treatment of non-small cell lung cancer (NSCLC) in recent years. The drug has been approved by the NMPA as a supplemental new drug application (sNDA) for the first-line treatment of patients with epidermal growth factor receptor (EGFR)-negative and PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC). This marks the second major approval of ivocilimab.

Approval of the sNDA was based on breakthrough results from the Phase III study of AK 112-303/HARMONi-2. The study was a randomized, double-blind, controlled trial that directly compared the efficacy of evocilizumab with pembrolizumab (pembrolizumab) in first-line PD-L1-positive non-small cell lung cancer. The results of the study showed that compared with pembrolizumab, evocilimab showed a statistically significant improvement in the primary endpoint of median progression-free survival (PFS), with a median PFS of 11.14 months and a hazard ratio (HR) of 0.51, which means a 49% reduction in the risk of disease progression or death. This remarkable efficacy makes evocilimab stand out as a treatment option.

In addition, in an interim analysis of overall survival (OS) that had reached 39% data maturity (α=0.0001), ivocilimab also had a clinically meaningful improvement in OS compared with pembrolizumab, with a hazard ratio of 0.777, reflecting a 22.3% reduction in the risk of death. It is worth noting that evocilimab is the first therapy to achieve statistically significant positive results in a phase III clinical trial, bringing new hope for the treatment of non-small cell lung cancer.

As the world's first approved bispecific antibody, ivocilizumab combines the dual mechanism of "cancer immunotherapy + anti-angiogenesis". Its efficacy is not only reflected in the treatment of EGFR-TKI-resistant non-small cell lung cancer, but also showed significant positive results in multiple phase III trials, including comparison with pembrolizumab and tislelizumab combined with chemotherapy.

Reference materials:https://www.akesobio.com/en/media/akeso-news/240908/