Akeso's Ivonescimab vs. Pembrolizumab Phase III Data Revealed at WCLC 2024

Akeso has revealed promising data on its innovative drug ivonescimab, a PD-1/VEGF bispecific antibody, at the IASLC 2024 World Conference on Lung Cancer. The findings come from a Phase III clinical trial comparing ivonescimab monotherapy to pembrolizumab monotherapy for treating PD-L1 positive advanced non-small cell lung cancer (NSCLC). The study shows that ivonescimab markedly enhances progression-free survival (PFS) and other key efficacy metrics compared to pembrolizumab.

Professor Caicun Zhou, a prominent figure in oncology, presented the trial results. The HARMONi-2 study demonstrated that ivonescimab significantly reduced the risk of disease progression or death, with a PFS hazard ratio of 0.51, indicating a 49% reduction in risk compared to pembrolizumab. The median progression-free survival (mPFS) for ivonescimab was 11.15 months, substantially longer than the 5.82 months observed with pembrolizumab.

Ivonescimab also showed superior results in the objective response rate (ORR) and disease control rate (DCR). The ORR was 50.0% for ivonescimab, outperforming pembrolizumab's 38.5%. Similarly, the DCR for ivonescimab was 89.9%, compared to 70.5% for pembrolizumab. These findings underscore the drug's potent anti-tumor efficacy.

The trial further analyzed subgroups based on PD-L1 expression and histological types. In patients with PD-L1 expression of 50% or higher, ivonescimab achieved a PFS hazard ratio of 0.46, and for those with PD-L1 expression between 1-49%, the hazard ratio was 0.54. The drug demonstrated significant benefits in both squamous and non-squamous NSCLC subtypes, with PFS hazard ratios of 0.48 and 0.54, respectively.

Moreover, ivonescimab showed significant benefits in refractory patient populations, including those with liver or brain metastases. The PFS hazard ratio for patients with brain metastases was 0.55, and 0.47 for those with liver metastases, highlighting ivonescimab's robust efficacy in challenging clinical scenarios.

Safety profiles were another critical aspect of the study. Ivonescimab demonstrated an acceptable and manageable safety profile across various subgroups, including those with high bleeding risk conditions like centrally located tumors or tumors with cavitation. The incidence of severe treatment-related adverse events in patients treated with ivonescimab was comparable to those treated with pembrolizumab, ensuring its safety alongside its efficacy.

Akeso's partner, Summit, plans to initiate another Phase III trial, HARMONi-7, in early 2025, focusing on patients with high PD-L1 expression. This trial aims to further establish ivonescimab's potential as a leading treatment for advanced NSCLC.

Dr. Michelle Xia, CEO of Akeso, expressed optimism about these findings, emphasizing the significant advancement ivonescimab represents in cancer immunotherapy. The drug's superior efficacy and manageable safety profile position it as a potential cornerstone in the treatment of various cancers, underscoring its global market potential.

Ivonescimab, known as AK112 in China and SMT112 in other licensed territories, has already been approved in China for certain NSCLC patients. Akeso has licensed its development and commercialization rights to Summit Therapeutics for regions including the United States, Europe, and Japan.

As the clinical development of ivonescimab advances, multiple Phase III studies are ongoing or planned. These include comparing ivonescimab combined with chemotherapy to existing treatments for various cancers, including squamous NSCLC and other solid tumors. Ivonescimab's extensive clinical trial program involves over 25 trials across 17 indications, targeting cancers like lung, pancreatic, and breast cancer, through both monotherapy and combination therapy approaches.

Akeso continues to leverage its robust R&D platform to develop innovative biological medicines, positioning itself as a leader in the global biopharmaceutical landscape.

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